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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 March 2026 has been entered.
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.
Claim(s) 1, 7-9, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0135703 (“Yeh”) in view of U.S. Publication No. 2017/0239443 (“Abitabilo”), U.S. Publication No. 2012/0016302 (“Stout”), U.S. Publication No. 2014/0046214 (“Devgon”), and WO 2011/011436 (“Byrne-Cabot”).
Regarding Claim 1, Yeh discloses a system (100, 110, 180) for facilitating instrument delivery through a peripheral intravenous catheter (130, 140) that includes a blood control valve (136) to obtain a blood sample through the peripheral intravenous catheter throughout a dwell time of the peripheral intravenous catheter (Par. 21), comprising:
A catheter assembly (130) comprising:
A catheter adapter (132) having a proximal end (634), a distal end (see Fig. 6A, i.e. the end to which the catheter 140 affixes), and a lumen extending therethrough (see Fig. 2), the proximal and distal ends being aligned on an axis (i.e. the longitudinal axis which extends concentrically therethrough as is aligned with the axis of the catheter 140);
A blood control valve (136) disposed in the lumen of the catheter adapter;
A peripheral intravenous catheter (140) extending distally from the distal end of the catheter adapter, the PIC being in fluid communication with the lumen (see Fig. 5);
A needle assembly (110) removably coupled to the proximal end of the catheter adapter (see Fig. 2-4), the needle assembly including an introducer needle (150) that inserts directly through the blood control valve and extends through the peripheral intravenous catheter to thereby allow the peripheral intravenous catheter to be inserted into a patient's vasculature overtop the introducer needle when the introducer needle is inserted into the patient's vasculature (see Fig. 1), and wherein the needle assembly is configured to be separated from the proximal end of the catheter adapter after the peripheral intravenous catheter is inserted into the patient's vasculature (see Fig. 4B, Par. 12); and
An extension set (180) that is configured to be coupled to the proximal end of the catheter adapter (see Fig. 4) after the needle assembly has been separated from the proximal end of the catheter adapter to thereby cause the introducer needle to be withdrawn from the blood control valve (Fig. 3), the extension set comprising:
a distal connector (182) coupled to the proximal end of the catheter adapter (see Fig. 4), the distal connector being configured to insert directly through the blood control valve when the distal connector is coupled to the proximal end of the catheter adapter to thereby bypass the blood control valve and form a fluid pathway through the blood control valve (see Fig. 5);
a proximal connector (184); and
tubing (186) disposed between the distal connector and the proximal connector.
Yeh discloses the invention substantially as claimed except that that the catheter adapter has a side port. However, such side ports are notoriously well-known in the art. For example, Abitabilo discloses a related catheter (100) which includes a hub/adapter (110) having a side port (not specifically labeled, see the section of the hub to which 114 affixes) and an extension tube (114) extending from the side port, the extension tube terminating in needleless connector (118) for permitting selective connection of additional fluid sources (186), the blood control valve (132) being disposed in the lumen of the catheter adapter proximal to the side port (see Fig. 10B). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Yeh with a side port and associated extension tube, as disclosed by Abitabilo, in order to allow for the connection of additional fluid sources as needed to deliver a multiplicity of fluids to the patient.
Yeh discloses the invention substantially as claimed except that that the blood control valve is “configured to vent air, but not blood”. Yeh discloses, explicitly, that the valve is configured to seal against blood (Par. 17), but no mention is made with respect to air sealing and venting is only discussed in the context of separate attachment of the introducer needle. However, Stout discloses a related catheter assembly (10) having a catheter hub (14) with a blood control valve (50) formed as a pre-slit septum (see at 56), wherein the blood control valve can be configured to vent air, but not blood thereby relieving pressure distal to the valve (Par. 49-53) allowing for blood flashback to be observable in the catheter hub (Par. 41) thereby ensuring that the catheter lumen is patent and remains properly located within the patient’s vein and the vein has not collapsed (Par. 41). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the blood control valve of Yeh to be configured to vent air, but not blood, as disclosed by Stout, in order to allow pressure distal to the valve to vent and thereby permit the creation of a distal flashback chamber in the catheter system that allows the clinician to confirm continued proper placement of the catheter within the vasculature, allowing visual confirmation that the catheter remains in the vein, the vein has not collapsed, and the catheter has not become obstructed/occluded.
Yeh discloses the invention substantially as claimed except that introducer needle includes a “distal notch” which is configured to allow primary flashback flow into a space formed between an exterior surface of the introducer needle and an interior surface of the peripheral intravenous catheter. However, such features are well-known to the prior art. For example, Abitabilo discloses an introducer needle (104) comprising a distal notch (276) which is configured to allow primary flashback to flow into a space between an exterior surface of the introducer needle and an interior surface of the peripheral intravenous catheter thereby allowing the clinician to view flashback through translucent portions of the catheter tube (Par. 112) as the introducer needle and PIC are inserted together into the patient’s vasculature to thereby cause the primary flashback to flow proximally within the PIC and the lumen toward the blood control valve (132). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the introducer needle of Yeh to comprise a distal notch and the catheter tube to comprise translucent portions, as disclosed by Abitabilo, in order to allow flashback to be observed through the catheter wall upon proper receipt of the system within the vasculature thereby ensuring that the clinician can accurately determine the presence of flashback at a variety of locations.
In performing such a modification to modified Yeh the blood control valve will be configured to vent air (see Stout) during insertion of the needle and catheter into the vasculature to thereby permit the flow of blood through the distal notch of the needle into the catheter tube and into the catheter hub toward the blood control valve.
Yeh, as modified, discloses the invention substantially as claimed except that that the proximal end of the extension tube comprises a Y-adapter coupled thereto. Abitabilo discloses that side ports and extension tubes (114) can be provided having a Y-adapter (115) coupled to a proximal end thereof, the Y-adapter comprising a first port (118A) and a second port (118B), wherein a first needless connector is coupled to the first port and a second needleless connector is coupled to the second port (see Fig. 28 – Par. 167). No mention is explicitly made as to whether these needleless connectors do or do not vent air. However, it is strongly implied by Abitabilo that the connectors are incapable of venting air inasmuch as the system discloses further inclusion of a vent cap (120) to provide venting (Par. 169), wherein the vent cap is not ordinary included in order to prevent extended compression of the seal which might cause premature failure of the seal (Par. 170). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a Y-adapter at the proximal end of the extension tube of modified Yeh, the Y-adapter comprising two needlessless connectors which are ordinarily non-venting, as disclosed by Abitabilo, in order allow a plurality of fluid sources to be selectively connectable to the catheter system as needed.
As modified, Yeh will be configured such that during insertion the modified blood control valve (see venting in view of Stout) alone will vent air during the insertion of the PIC thereby allowing the primary flashback to flow within the catheter and catheter hub (see the notched introducer needle in view of Abitabilo), the needless connectors at the extension tubing (see modifications in view of Abitabilo) being non-venting.
Yeh discloses the invention substantially as claimed except that that the system further comprises an “instrument delivery device for obtaining a blood sample through the peripheral intravenous catheter”. However, Devgon discloses in the art of peripheral intravenous catheters (6300) it is known to use the catheter to provide additional medical devices for blood draws and the like. Devgon disclose an instrument delivery device (6100) may be provided to communicate with the proximal end of an adapter/extension set (6431; 6430) which has been affixed to the PIC (6300). Devgon discloses the instrument delivery device to comprise:
A housing (inter alia 6120 to 6131) having a distal end (6131) that is configured to be coupled to the proximal connector of the adapter/extension set (see generally Fig. 9), the housing including a slot (not shown - see generally 1111; note the advancement of 6520 – Fig. 11 and 12) that extends along a length of the housing;
An additional catheter (6200) contained within the housing; and
An additional catheter (6200) contained within the housing; and
An advancement tab (6500) positioned in the slot that is configured to advance the additional catheter distally from the housing when the distal end of the housing is coupled to the proximal connector of the adapter/extension set to thereby cause the additional catheter to pass distally along the axis through the catheter adapter and the peripheral intravenous catheter (see Fig. 11 and 12 in series), the additional catheter having a length sufficient to cause a distal end of the additional catheter to extend distally beyond a distal end of the peripheral intravenous catheter to thereby enable blood draw through the additional catheter while the additional catheter is advanced trough the peripheral intravenous catheter (see Fig. 13; Par. 8 and 84).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a suitably dimensioned intravenous delivery device configured to be received through the modified distal connector of the modified extension set/adapter and thereby bypass the blood control valve of the system of Yeh and to be delivered through the peripheral intravenous catheter, as disclosed by Devgon, in order to allow a clinician to provide for phlebotomy through a PIC while overcoming the difficulties recognized by Devgon (Par. 2-7 – Devgon).
Devgon describes that the introducer (6100) may be paired with not only the “adapter 6400” shown, but also “any other suitable intervening structure, such as, for example, a known valve or cap” (Par. 71). As such, the modified adapter of Yeh is merely one type of adapter that the ordinary artisan would have found obvious to pair a suitable length introducer of Devgon with, in order to allow the device to bypass the valve in a known and predictable manner through the patent conduit formed by the extension set/adapter.
For example, Byrne-Cabot discloses a related catheter (20) which is provided with a related extension set/adapter (30) which like that of Yeh provides for a distal connector (38), a proximal connector (39) and flexible tubing therebetween (34), whereby the extension set/adapter may serve to provide for receipt a secondary catheter system (40, 50) therethrough in a nested fashion (see Fig. 3) with the tubing straightened to permit receipt therethrough. As such, the ordinary artisan would have found it obvious and predictable to use the modified invention of Yeh to introduce any of a variety of interventional appliances, including those described by Devgon, via a clear expectation for success for nesting together such interventional appliances (see Byrne-Cabot). Any modifications as to the relative dimensions of the various components of modified Yeh needed to ensure interoperability is held to be an obvious design constraint requiring only routine and customary skill in the art, whereby such changes in size and proportion necessary to carry forward the principle matters of an invention is obvious, see In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
Regarding Claim 7, Yeh discloses a needleless connector (188) coupled to the proximal end of the catheter adapter (see Fig. 5), the distal connector of the extension set being configured to couple to the proximal end of the catheter adapter via the needleless connector (see Fig. 5).
Regarding Claim 8, Yeh discloses the distal connector of the extension set comprises a cannula (188) that penetrates the blood control valve in response to the distal connector being coupled to the proximal end of the catheter adapter (see Fig. 5).
Regarding Claim 9, Yeh discloses the proximal connector of the extension set comprises a needleless connector (184).
Regarding Claim 19, Yeh discloses the proximal end of the catheter adapter comprises a non-luer adapter (see Fig. 5).
Regarding Claim 20, Yeh discloses a distal portion of the lumen is narrowed to provide a guide feature (see Fig. 5).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0135703 (“Yeh”) in view of U.S. Publication No. 2017/0239443 (“Abitabilo”), U.S. Publication No. 2012/0016302 (“Stout”), U.S. Publication No. 2014/0046214 (“Devgon”), and WO 2011/011436 (“Byrne-Cabot”) as applied above, and further in view of U.S. Patent No. 5,807,347 (“Bonaldo”).
Regarding Claim 6, Yeh discloses the invention substantially as claimed for a cap coupled to the proximal end of the catheter adapter when the extension set distal end is not coupled to the catheter adapter proximal end. However, Bonaldo discloses a related catheter adapter (65) which can be provided with a cap (83) selectively affixable to the proximal end of the catheter to protect the sterility of the fitting. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the system of Yeh with a cap which may be selectively attached and removed from the proximal end of the catheter adapter after the needle assembly has been removed, but before the distal connector of the extension set is coupled, as disclosed by Bonaldo, in order to protect the proximal end (and valve) from exposure to contaminants when not in use.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0135703 (“Yeh”) in view of U.S. Publication No. 2017/0239443 (“Abitabilo”), U.S. Publication No. 2012/0016302 (“Stout”), U.S. Publication No. 2014/0046214 (“Devgon”), and WO 2011/011436 (“Byrne-Cabot”) as applied above, and further in view of U.S. Patent No. 6,213,996 (“Jepson”).
Regarding Claim 10, Yeh discloses the cannula is blunt (see Fig. 5), but fails to explicitly discloses a “plastic or steel” construction. However, the use of such plastic materials is notoriously well-known in the art (see Jepson Fig. 4B – note the cross-hatching, see MPEP 608.02, see Jepson at Col. 3). It would have been obvious for one having ordinary skill in the art at the time the invention was made to use a plastic material for the blunt cannula, as disclosed by Jepson, whereby it has been held that selection of a specific art-recognized material based upon its recognized suitability for a specific purpose is obvious, achieving only predictable and expected results, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding Claim 11, Yeh discloses the invention substantially as claimed that the cannula comprises a plurality of flushing windows. However, Jepson, as discussed above, discloses a related blunted cannula wherein the cannula has various provision including to a plurality of flushing windows (e.g. 294) to facilitate fluid flow, but also to decrease surface contact area and further minimize insertion force (see Col. 12). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the cannula of Yeh with a plurality of flushing windows, as disclosed by Jepson, in order to allow for diffuse fluid flow through the cannula while also reducing the necessary insertion force.
Claim(s) 12-13 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0135703 (“Yeh”) in view of U.S. Publication No. 2017/0239443 (“Abitabilo”), U.S. Publication No. 2012/0016302 (“Stout”), U.S. Publication No. 2014/0046214 (“Devgon”), and WO 2011/011436 (“Byrne-Cabot”) as applied above, and further in view of U.S. Publication No. 2003/0105452 (“Mayer”).
Regarding Claim 12-13, Yeh discloses the proximal connector of the extension set to comprise a needleless connector (184), but fails to disclose that that the distal connector of the extension set comprises a male luer, rather Yeh discloses using locking wings (190) to interface the distal connector to the proximal end (191) of the catheter adapter. However, Mayer discloses a related blood control valve system (10, 16) likewise configured to interface with an extension set (e.g. 54, 56) wherein the extension set comprises an elongated cannula/actuator (54) forming an extension of the male luer fitting to open the blood control valve interface (see generally Fig. 15) wherein the proximal end of the catheter adapter and the distal connector comprise corresponding luer fittings with the distal connector comprising a male luer, such a luer being a standardized and typical connecting geometry. It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the wing-type connectors of the invention of Yeh with a standardized luer lock arrangement, as disclosed by Mayer, in order to utilize a well-known and predictable connection interface with the luer threads being understood to be a more secure connection by virtue of the cooperative threads and greater contact area between the connection.
Regarding Claim 18, Yeh discloses the invention substantially as claimed except that the proximal end of the catheter adapter comprises a luer fitting. However, Mayer discloses a related blood control valve system (10, 16) which utilizes a standardized luer fitting (70) to permit the attachment of a diverse set of ancillary equipment (see Fig. 6). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the proximal end of the invention of Yeh to comprise a standardized luer fitting, as disclosed by Mayer, in order to permit standardized equipment to be selectively affixed directly to the proximal end of the catheter adapter in order to directly deliver fluids as needed.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues (Pg. 4) “The obviousness inquiry requires more. In Yeh, it appears venting is structurally separated from the catheter adapter and occurs in the needle assembly”. However, here Stout provides clear direction and motivation as to why air venting of a blood control valve/septum is known to be useful in order to allowing for continued venting of air, while sealing egress of blood, to permit confirmation of maintained patency of the catheter inserted within the catheter. Along with Stout, Abitabilo maintains that a plurality of flashback indicators can be relied upon and observance of flashback through the catheter and catheter hub in place of or in addition to a separate flashback chamber within the introducer needle is known, obvious, beneficial, and presents only expected and predictable results.
Applicant argues (Pg. 4) that “if the combination were made, it would be necessary to consider whether the side port would be proximal or distal to the seal”. However, this is not persuasive inasmuch as Abitabilo already settles such a consideration (see Fig. 10B) wherein an equivalent blood control valve (132) is provided at a location proximal to the side port (150).
Applicant argues (Pg. 4) that “it would be necessary to consider… whether the flashback pathway would need to be redesigned”. However, this is not persuasive. Specifically, the occurrence of flashback, as described by the instantly claimed invention, via a notched needle into a transparent catheter and hub is well-known as exemplified by Abitabilo which provides for such a configuration in catheter hubs having side ports establishing known expected and predictable results. Furthermore, venting of the blood control valve is separately obvious, in view of Stout, to permit flashback to be observed within the catheter hub after placement of the catheter to ensure continued patency of the catheter and proper placement of the catheter within patent vasculature.
Applicant argues (Pg. 4) that “it would be necessary to consider… whether changes in pressure or priming dynamics would impact function”. However, this is not persuasive inasmuch as Abitabilo already largely resolves a similar catheter system which implements a side-port having a Y-adapter extension wherein the a venting plug (120) is not integral, but optionally included in a configuration without prior installation (Par. 170). Whether the valve (120) is or is not installed during use is a product of clinician preference should its necessity be later determined by the clinician. As such, it is understood that the needless connectors of Abitabilo are no inherently vented and are supplied to a clinician in an ordinarily non-vented configuration since the vent cap is not provided pre-installed. Furthermore, it has been held that elimination of a component and its function is obvious, see Ex Parte Wu, whereby venting of air and flashback during placement is already resolvable via flashback observable in either the needle or catheter/catheter hub (see Abitabilo) and whereby flashback can be continually observed after placement and removal of the needle within the catheter hub in view of Stout through obvious modifications to the blood control valve to make the valve venting to air, but not to blood. Again, because the venting plug (120) of Abitabilo is provided separately, this plug can be later installed, as needed should the clinician later determine that observing flashback within the side branch and the extension tubing is desirable, but otherwise since the venting and flashback confirmation through the extension tubing is redundant in view of features described by Abitabilo and/or Stout elimination of the venting plug entirely is contemplatable and obvious.
Finally, the instant specification appears suggestive that the venting of the blood control valve and the venting of the needleless valves of the Y-adapter are nominal variants of one another requiring little, if any, additional consideration as to whether or not they can be implemented between embodiments. Specifically, in embodiments where the blood control valve lies proximally of the side port (as claimed) it is recited that “the blood control valve may not allow air venting” (Par. 9). Likewise venting of air by the blood control valve is recited as something that “may” be allowed when the system uses a Y-adapter at the proximal end of the extension tube (Par. 10). The needless connectors (40a/b) are recited, as non-limiting examples, as being of the venting type (Par. 34) or that vent-plugs can be provided separately without any substantial consideration (Par. 34). Venting and non-venting arrangements appear to be disclosed as alternatives to one another (Par. 41-42) that can simply be replaced without any significant consideration. The significance of the venting of the blood control valve is only explicitly considered with respect to the ability to confirm flashback (see Par. 10, 42) a function which is wholly expected and predictable as discussed by Stout (see above).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 07/17/2026
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