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 .
Response to Amendment
The amendment filed 03/12/2026 has been entered. Amendments to claims 1, 9, 11, 13, 17, 19, and 20, and cancellation of claims 7-8, 10, and 21. Claims 1-6, 9, and 11-20 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 11/14/2025.
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 1-6, 9, and 11-20 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.
The term “approximately” in claims 1 and 17 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “approximately” renders the length of the blunt cannula indefinite as it is unclear to what degree it must extend to a distal end of the cavity.
Claims 2-6, 9, 11-16, and 18-20 are rejected due to dependency.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 and 5-6, 9, 11-17, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Devgon et al. (US 20200100716 A1, as cited by applicant’s IDS file 04/26/2023), hereinafter Devgon.
Regarding claim 1, Devgon discloses a catheter system ([0030]: " systems, devices, and methods for aspirating bodily fluid from a patient via an indwelling vascular access device such as a peripheral intravenous line… relatively soft and/or flexible catheter") comprising: a catheter having a catheter distal end and a catheter proximal end, the catheter defining a catheter lumen ([0033]: "catheter has a proximal end portion and a distal end portion and defines a lumen therethrough"); a catheter hub coupled to the catheter proximal end ([0034]: “end portion of the hub is coupled to the first catheter such that a lumen of the first catheter is in fluid communication with the central lumen of the hub”), the catheter hub comprising: a hub body having a hub distal end and a hub proximal end, the hub body having a cavity formed therein extending between the hub distal end and the hub proximal end ([0034]: "The hub has a proximal end portion and a distal end portion and defines a central lumen therethrough."); and an end port positioned at the hub proximal end and providing an opening into the cavity ([0034]: “The distal end portion of the hub has a first port that defines a seal member. The seal is configured to be transitioned from an open state to a closed state after the first catheter is disposed within the portion of the body.”); and a split-septum connector positioned at least partially within the end port ([0060]: " the seal 274 can be pierceable member, a self-sealing and/or self-healing member, a valve, a split septum,".), the split- septum connector configured to seal the cavity when in a closed configuration and provide a fluid path to the catheter lumen when in an open configuration ([0059]: “when the seal 274 is in an open configuration or state, the lumen 275 of the hub 271 can be accessed via the proximal port 273 and when the seal 274 is in a closed configuration and/or state, the access to the lumen 275 of the hub 271 via the proximal port 273 is blocked and/or prevented”); and a blood draw device ([0068]: “fluid transfer device”), the blood draw device coupled to the end port and/or the split- septum connector ([0068]; ", the fluid transfer device 210 can be used with (e.g., coupled to) the access device 270 and manipulated to withdraw a volume of blood from the vein of the patient into one or more fluid collection devices, reservoirs, containers, etc."), a secondary catheter (Fig 5 element 245); an introducer (Fig 5 element 215) having a proximal end (Fig 5 element 216) and a distal end (Fig 5 element 217), and a top surface and a bottom surface, that define an inner volume configured to movably receive the secondary catheter ([0070]: “the introducer 215 defines an inner volume within which at least a portion of the catheter 230 and at least a portion of the actuator 220 are movably disposed”); an actuator movably coupled to the introducer (Fig 5 element 220), the actuator configured to move relative to the introducer to move a distal end of the secondary catheter from a position within the introducer to a position outside the introducer housing and past the catheter distal end of the catheter ([0070]: “As described in further detail herein, prior to use, the catheter 230 can be in a first position, configuration, and/or state in which the catheter 230 is disposed or substantially disposed within the inner volume of the introducer 215. Such an arrangement can, for example, protect the catheter 230 from being physically damaged prior to use and/or protect the catheter 230 from being contaminated by a nonsterile environment. In use, the catheter 230 can be transitioned to a second position, configuration, and/or state in which at least a portion of the catheter 230 is distal to and outside of the introducer 215.”); and a connector positioned at the distal end of the introducer that is coupled to the end port and/or the split-septum connector (Fig 5 element 240), the connector comprising a blunt cannula and a pair of locking arms (Fig 5 element 241 and 242); wherein when the blood draw device is coupled to the end port and/or the split-septum connector (Fig 6, wherein element 242 is connected to 274), the blunt cannula penetrates through the split-septum connector and into the cavity (Fig 6 element 242), with each of the blunt cannula and the cavity having a length such that the blunt cannula extends approximately to a distal end of the cavity (Fig 6 element 242 extending through element 271).
Regarding claim 2, Devgon further discloses wherein the catheter hub further comprises a side port extending out from the hub body between the hub distal end and the hub proximal end, the side port defining a side port lumen in fluid communication with the catheter lumen ([0061]: "side port 276 of the access device 270", Fig 3 element 276).
Regarding claim 3, Devgon further discloses wherein the side port extends out from the hub body at an angle relative to the catheter lumen of between 15-165 degrees (Fig 3, wherein side port 276 forms a 45 degree angle).
Regarding claim 5, Devgon further discloses a needle-free access connector coupled to the side port ([0060]: "a needle-free connector").
Regarding claim 6, Devgon further discloses wherein the cavity comprises a cylindrical cavity having a constant diameter along at least a majority of a length thereof between the hub distal end and the hub proximal end (Fig 3, element 272).
Regarding claim 9, Devgon further discloses wherein the split-septum connector comprises a first ring and a second ring spaced apart laterally from the first ring (Fig 6 element 274 and the ring formed at the end of element 217) and wherein the pair of locking arms engages the split-septum connector by snapping-in between the first ring and the second ring (Fig 6 element 241).
Regarding claim 11, Devgon further discloses wherein extension of the blunt cannula to approximately the distal end of the cavity places a lumen of the blunt cannula adjacent the catheter lumen (Fig 6 element 242 through lumen 275).
Regarding claim 12, Devgon further discloses wherein the catheter hub further comprises a wedge positioned within the cavity adjacent the hub distal end, the wedge coupled to the catheter proximal end to retain the catheter to the catheter hub, and wherein the wedge includes a wedge lumen formed therein, and extension of the blunt cannula to approximately the distal end of the cavity directly aligns the lumen of the blunt cannula with the wedge lumen ([0034]: “The hub has a guide defining at least a portion of the central lumen that is configured to engage a second catheter inserted through the second port to guide the second catheter through the central lumen of the hub and into the lumen of the first catheter.”).
Regarding claim 13, Devgon further discloses wherein the split-septum connector is positioned entirely within the end port (Fig 6 element 274), and wherein the pair of locking arms engages a groove formed on an outer surface of the end port ([0076]: “the set of arms 241 can be configured to engage an outer surface of the proximal port 273 of the access device 270 when the lock 240 is coupled thereto.”).
Regarding claim 14, Devgon further discloses a needle introducer coupled to the split-septum connector ([0070]: “the introducer”, Fig 6 element 215 as connected to 274), with a needle extending through the catheter hub and through the catheter lumen, and wherein the split-septum connector is configured to have an initial configuration where a first portion of the split-septum connector is separated from a second portion of the split-septum connector ([0064]: “the body 291 of the insertion device can be coupled to the proximal port 273 of the access device 270 such that the insertion member 292 extends through the lumen 275 defined by the hub 271 and through the catheter 272. The coupling of the access device 270 and the insertion device 290 is such that the seal 274 of the access device 270 is placed in an open state and/or configuration by the insertion member 292 extending therethrough.”), such that the needle passes through the split-septum connector without making contact therewith ([0035]: “A seal included in the proximal port of the hub is transitioned from a closed state to an open state as a result of the coupling of the introducer to the proximal port of the hub.”, [0056]: “engage a portion of the hub 171 of the access device 170 to transition the seal 174 from its closed state to its open state. The transitioning of the seal 174 to the open state and/or configuration, in turn, can allow the catheter 130 of the fluid transfer device 110 to be advanced through the access device 170”, wherein the coupling of the introducer may transition to an open or close state without the needle).
Regarding claim 15, Devgon further discloses wherein the catheter hub comprises an open peripheral intravenous catheter (PIVC) catheter hub ([0039]: " PIV catheter ").
Regarding claim 16, Devgon further discloses wherein the split-septum connector comprises a side port formed thereon, with an integrated extension tube extending out from the side port ([0175]: “the port 2665 can be and/or can include, for example, a Luer Lok™ (e.g., a female luer), a split septum, a needle free connector, and/or any other suitable port. As such, a fluid transfer device can be coupled to the port 2665 and can be manipulated to advance a catheter of the fluid transfer device through the port 2665 and the tubing 2662, through the side port of the access device (not shown), and toward and/or beyond a catheter of the access device”)
Regarding claim 17, Devgon discloses a catheter system ([0030]: " systems, devices, and methods for aspirating bodily fluid from a patient via an indwelling vascular access device such as a peripheral intravenous line… relatively soft and/or flexible catheter") comprising: a catheter having a catheter distal end and a catheter proximal end, the catheter defining a catheter lumen ([0033]: "catheter has a proximal end portion and a distal end portion and defines a lumen therethrough"); a catheter hub coupled to the catheter proximal end ([0034]: “end portion of the hub is coupled to the first catheter such that a lumen of the first catheter is in fluid communication with the central lumen of the hub”), the catheter hub comprising: a hub body having a hub distal end and a hub proximal end, the hub body having a cavity formed therein extending between the hub distal end and the hub proximal end ([0034]: "The hub has a proximal end portion and a distal end portion and defines a central lumen therethrough."); an end port positioned at the hub proximal end and providing an opening into the cavity ([0034]: “The distal end portion of the hub has a first port that defines a seal member. The seal is configured to be transitioned from an open state to a closed state after the first catheter is disposed within the portion of the body.”); and a fluid cut-off positioned at or adjacent the end port, ([0102]: " one or more of the seals (e.g., latches, flaps, etc.) can define a notch, cutout, contour, and/or the like that is exposed when the seal 674 is placed in the open configuration… ".), the fluid cut off configured to seal the cavity when in a closed configuration and provide a fluid path to the catheter lumen when in an open configuration ([0102]: “the seal 674 can be disposed in a substantially closed or sealed state or configuration, in which the multiple latches, flaps, etc. form a substantially fluid tight seal therebetween (e.g., the notch, cutout, contour, and/or the like is substantially obstructed, occluded, blocked, covered, etc.”).
Regarding claim 20, Devgon further discloses a deformable tubing coupled to the end port and extending our proximally therefrom ([0140]: the side port 1476 can be coupled to tubing 1451 and can be in fluid communication with a lumen 1453 defined by the tubing 1451. The tubing 1451 can be of any predetermined length to be compatible with the catheter 1430 of suitable length.”) , and wherein the fluid cut-off comprises a slide clamp positioned on the deformable tubing and actuatable between an open position and a closed position to selectively allow fluid flow through the deformable tubing ([0140]: “the tubing 1451 can be configured to include a proximal coupler 1454 that can be configured as a threaded coupler, a slidable collar, one or more engagement members, a male or female luer lock (e.g., a slip luer or a locking luer)”).
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.
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon.
Regarding claim 4, Devgon discloses the catheter system of claim 1. In a different embodiment, Devgon further discloses wherein the side port comprises a female luer connection ([0049]: “the proximal port 173 of the hub 171 can be a luer lock (e.g., a male or female luer lock) or the like within which the seal 174 is disposed”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the side port to include the luer connection as disclosed in a different embodiment to form a more secure connection.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Bullington et al. (US 20190175087 A1), hereinafter Bullington.
Regarding claim 18, Devgon discloses the catheter system of claim 17 but fails to disclose wherein the fluid cut-off comprises: a stop cock valve within the cavity adjacent the end port; and an actuator positioned on an outer surface of the hub body and operable to open and close the stop cock valve.
Bullington discloses a catheter system (Fig 5) including a fluid cut-off ([0060]: “modify access to one or more openings to allow a flow of air or gas disposed within parts of the sequestration portion”) comprising: a stop cock valve ([0060]: “external control mechanisms (e.g. a switch, stop cock, lever, clamp, or press-button activated flow blocks, etc.)”) within the cavity adjacent the end port (Fig 1 element 150 within cavity 134); and an actuator positioned on an outer surface of the hub body (Fig 5 element 350 adjacent to end port 332) and operable to open and close the stop cock valve ([0060]: “the actuator 150 can be configured to physically block or occlude of one or more openings in one or more portions of the fluid flow path 133”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known fluid cut-off disclosed by Devgon to the known stop cock valve disclosed by Bullington for the predictable result of controlling fluid flow.
Regarding claim 19, Devgon as modified by Bullington discloses the catheter system of claim 18, and Bullington further discloses a split-septum connector within the cavity and proximal from the stop cock valve. ([0187]: “an opening, port, coupler, septum, Luer-Lok, gasket, valve, threaded connecter, standard fluidic interface, etc. (referred to for simplicity as a “port”) in fluid communication with the sequestration chamber.”).
Response to Arguments
Applicant's arguments filed 03/12/2026 have been fully considered but they are not persuasive.
Applicant argues on page 10 that Devgon fails to disclose a blunt cannula that extends approximately to a distal end of the cavity. However, applicant does not clearly define what “approximately to a distal end” refers to (see rejection above). As per Fig 6, the end of element 242 is closer to the distal end than the proximal end. Additionally, Devgon states that the proboscis may have a variable length ([0077], and applicant’s remarks page 10). As such, applicant’s arguments are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Naing et al (US 20180256857 A1) – discloses a blunt cannula that extends to a distal end of a cavity
Wyatt (US 5603706 A) – discloses a blunt cannula that extends to a distal end of a cavity (See fig 8B)
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 8:30 - 5:30 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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