DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 26 March 2026. The Examiner acknowledges the amendments to claims 1 and 4-5, the cancelation of claims 14-22, and the addition of new claims 34-35. Claims 1-13 and 34-35 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).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1, 3, 6, and 8-9 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 4, 9-11, and 13 of copending Application No. 18/725,207, hereinafter Hu, in view of Jepson (US-6261282-B1).
Claim 1 of conflicting Hu patent application is considered to anticipate each and every limitation of claim 1 of the instant application [see comparison below], except for wherein the connector comprises a “proximal end”, the proximal end “including the septum”, and “wherein with the housing coupled to the connector, the proximal end of the connector and the septum are positioned within the housing”.
Jepson discloses a catheter system comprising a connector coupled to a catheter and comprising a proximal end including a septum [The connector 10 generally provides multiple fluid connections with a penetrating member 12 (FIG. 2). In an example, the connector 10 may be attached to a conduit 14 in fluid communication with the human body. The conduit 14 may be a peripheral catheter 15, medical tubing or the like and forming a passageway 16 in fluid communication with the body for the flow of fluid to or from a body (Jepson Col 7:35-43, Fig. 1); the connector 10 includes a housing 26 and an elastic and resilient resealable member 27, preferably a septum 28, disposed at an upper end 30 of the housing to seal an opening 32 defined by the upper end 30 (Jepson Col 7:60-64, Fig. 1), wherein the upper end 30 is considered to be the “proximal” end of the connector]; and a blood collection set, comprising a housing, wherein the housing is coupled to the connector, wherein the housing is configured to create a fluid path through the connector [Referring to FIG. 2, in an example, the penetrating member 12 is preferably a male luer slip or luer lock 13 conforming to ANSI or ISO standards; however, examples of other members, with appropriate modifications to the housing and septum, may include blunt cannula, needles, specially designed connectors or the like. The luer lock 13 includes a luer tip 18 which, in the embodiment shown, is encircled by a locking flange 20 and forms the end of a syringe 24. Other devices which may utilize a penetrating member 12 include I.V. sets, blood collection and peritoneal dialysis devices and the like (Jepson Col 7:48-58, Fig. 2), wherein the structure of the penetrating member 12 defines a housing that includes locking flange 20]; wherein with the housing coupled to the connector, the proximal end of the connector and the septum are positioned within the housing [wherein as depicted in Jepson Fig. 2, the upper end 30 (proximal end) and the septum 28 (septum) are positioned within the locking flange 20 of the housing formed by penetrating member 12 when the connector 10 (connector) is coupled to the penetrating member 12 (structurally defines a housing)].
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 Hu to employ wherein the connector comprises a “proximal end”, the proximal end “including the septum”, and “wherein with the housing coupled to the connector, the proximal end of the connector and the septum are positioned within the housing”, 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 [define a particular position of the septum and allow for coupling between the connector and the housing of the blood collection set] [MPEP § 2143(I)(D)].
Claims 4, 9-11, and 13 of the conflicting Hu patent application in view of Jepson are further considered to anticipate dependent claims 3, 6, and 8-9 of the instant application.
Claim 1 of the Instant Application
Claim 1 of Conflicting Patent Application 18/725,207 (Hu)
A catheter system, comprising:
A catheter system, comprising: [claim 1 line 1]
a catheter adapter, comprising a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter;
a catheter adapter, comprising a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; [claim 1 lines 2-5]
a catheter extending distally from the distal end of the catheter adapter;
a catheter extending distally from the distal end of the catheter adapter; [claim 1 lines 6-7]
a connector coupled to the catheter adapter and comprising a septum; and
a connector coupled to the catheter adapter and comprising a septum; [claim 1 lines 8-9]
a blood collection set, comprising a needle assembly and a housing, wherein the housing is coupled to the connector, wherein the housing is configured to create a fluid path through the connector.
a blood collection adapter coupled to the connector, wherein the blood collection adapter is configured to create a fluid path through the connector; and a blood collection set coupled to the blood collection adapter, the blood collection set comprising a needle assembly configured to receive a blood collection container [claim 1 lines 10-16]
[wherein the Examiner notes that the recited blood collection adapter of Hu may be considered to read on the broadest reasonable interpretation of the instantly claimed “housing” due to the lack of further structural detail of the instantly claimed “housing”]
This is a provisional nonstatutory double patenting rejection.
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, 3, 6-7, 9, 11-13, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jepson (US-6261282-B1) in view of Close (US-20140188002-A1, previously presented).
Regarding claim 1, Jepson teaches
A catheter system, comprising:
a connector coupled to a catheter and comprising a proximal end including a septum [The connector 10 generally provides multiple fluid connections with a penetrating member 12 (FIG. 2). In an example, the connector 10 may be attached to a conduit 14 in fluid communication with the human body. The conduit 14 may be a peripheral catheter 15, medical tubing or the like and forming a passageway 16 in fluid communication with the body for the flow of fluid to or from a body (Jepson Col 7:35-43, Fig. 1); the connector 10 includes a housing 26 and an elastic and resilient resealable member 27, preferably a septum 28, disposed at an upper end 30 of the housing to seal an opening 32 defined by the upper end 30 (Jepson Col 7:60-64, Fig. 1), wherein the upper end 30 is considered to be the “proximal” end of the connector]; and
a blood collection set, comprising a housing, wherein the housing is coupled to the connector, wherein the housing is configured to create a fluid path through the connector [Referring to FIG. 2, in an example, the penetrating member 12 is preferably a male luer slip or luer lock 13 conforming to ANSI or ISO standards; however, examples of other members, with appropriate modifications to the housing and septum, may include blunt cannula, needles, specially designed connectors or the like. The luer lock 13 includes a luer tip 18 which, in the embodiment shown, is encircled by a locking flange 20 and forms the end of a syringe 24. Other devices which may utilize a penetrating member 12 include I.V. sets, blood collection and peritoneal dialysis devices and the like (Jepson Col 7:48-58, Fig. 2), wherein the structure of the penetrating member 12 defines a housing that includes locking flange 20];
wherein with the housing coupled to the connector, the proximal end of the connector and the septum are positioned within the housing [wherein as depicted in Jepson Fig. 2, the upper end 30 (proximal end) and the septum 28 (septum) are positioned within the locking flange 20 of the housing formed by penetrating member 12 when the connector 10 (connector) is coupled to the penetrating member 12 (structurally defines a housing)].
However, while Fields discloses that the connector is coupled to a catheter, Fields fails to explicitly disclose a catheter adapter, comprising a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending distally from the distal end of the catheter adapter, such that the connector is coupled to the catheter adapter; and wherein the fluid pathway set is a blood collection set that further comprises a needle assembly.
Close discloses a catheter system comprising a catheter adapter, comprising a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter [catheter head assembly 200 (Close Fig. 13); a catheter head assembly 200 for fluid coupling with the catheter 20. The blood collection lumen 150 and intravenous infusion lumen 160 couple the catheter head assembly 200 to the transfer valve and collection body 140 (Close ¶0115, Fig. 12); The catheter head body 202 provides fluid coupling between the microlumen 210 and blood collection lumen 150 (Close ¶0117), wherein the portion of catheter head 200 coupled to the catheter 20 is considered to define a distal end, and wherein the portion of catheter head assembly 200 coupled to the microlumen stabilizer pull handle 206 is considered to define a proximal end (see Close Fig. 13)]; a catheter extending distally from the distal end of the catheter adapter [catheter 20 (Close Fig. 13); The distal end of the catheter head body 202 includes a connector 204 for coupling the connector 83 (FIG. 23) at the proximate end 24 of a standard venous catheter 20 (Close ¶0116)]; a connector coupled to the catheter adapter [transfer valve housing 142 (Close Fig. 16); FIG. 18 and various subsequent FIGS. shows a semi-transparent view of the transfer valve housing 142, including fluid passageways defined by portions of the housing top 144, elastomeric valve layer 190, rotary valve 182. These fluid passageways are selectively in fluid communication with… the blood collection lumen 150 (Close ¶0127)]; and a blood collection set, comprising a needle assembly [tube penetration needle 136 (Close Fig. 22)] and a housing [tube holder 120 (Close Figs. 12, 15)], wherein the housing is coupled to the connector, wherein the housing is configured to create a fluid path through the connector [Additionally, in the infusion/collection mode of operation, the needleless draw nozzle 132 is in fluid communication with the needleless draw port 154, and thus the blood collection channel 152 is further defined in this operating mode by the needleless draw nozzle 132 and tube penetration needle 136 (Close ¶0129); FIG. 22 also shows the collection tube penetration needle 136 that is coupled to the tube holder 120, projecting upwardly into the center of tube receptacle 128, and in fluid communication with the needleless draw nozzle 132 (Close ¶0132)].
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 Jepson to employ a catheter adapter, comprising a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending distally from the distal end of the catheter adapter, such that the connector is coupled to the catheter adapter; and wherein the blood collection set further comprises a needle assembly, as these modifications would amount to mere simple substitution of known elements for another to obtain predictable results [define a fluid pathway from a catheter to a blood collection set to allow for blood collection] [MPEP § 2143(I)(B)] and merely applying a known technique to a known device (method, or product) to yield predictable results [define a fluid pathway from a catheter to a blood collection set to allow for blood collection] [MPEP § 2143(I)(D)].
Regarding claim 3, Jepson in view of Close teaches
The catheter system of claim 1, wherein the housing is integrated with the needle assembly [See § 103 modification of claim 1, above; FIG. 22 also shows the collection tube penetration needle 136 that is coupled to the tube holder 120 (Close ¶0132, Fig. 22)].
Regarding claim 6, Jepson in view of Close teaches
The catheter system of claim 1, wherein the connector is a needleless connector [Jepson Fig. 2].
Regarding claim 7, Jepson in view of Close teaches
The catheter system of claim 6, wherein the housing is disposed in a proximal position, wherein the housing comprises a male luer, wherein the male luer is configured to activate the septum and create the fluid path through the connector in response to the housing being moved from the proximal position to a distal position, wherein the housing is threaded from the proximal position to the distal position or pushed from the proximal position to the distal position [The other type is generally referred to as a luer lock connection whereby the male luer tip is encircled by an annular flange having a threaded internal surface. The female component includes a corresponding thread formed about the outer surface. Engaging the threaded flange to the threaded outside surface establishes the connection between the male luer tip and female component while preventing accidental disconnects (Jepson Col 1:45-52); Referring to FIG. 2, to insure universal connectivity, it is preferable that dimensions of luer connecting devices are standardized to ISO standards. For example, the dimensions of the luer tip 18 including the taper are set by the standard. Similarly, threads 64 on the inside of the locking flange 20 define a clearance radius which is set by the standard. As can be appreciated, when the male luer tip 18 extends within the connector 10 and the locking flange 20 extends about the exterior of the connector, the size of the connector and its components are constrained within the spacing between the luer tip and locking flange. Also, according to ISO standards, the male luer tip 18 should be able to penetrate to a desired insertion depth "D" of 0.300 inches which additionally constrains the size of the connector 12 and its components particularly about the upper end 30 of the housing 26 which must fit within the spacing between the luer tip 18 and locking flange 20 (Jepson Col 8:56-9:6), wherein the Examiner notes that a threaded connection between the housing that defines a male luer and the connector is considered to read on a proximal/unthreaded position and a distal/threaded position as claimed].
Regarding claim 9, Jepson in view of Close teaches
The catheter system of claim 1, wherein the housing comprises a cannula configured to penetrate the septum of the connector to create the fluid path through the connector [Jepson Col 7:48-58, Fig. 2].
Regarding claim 11, Jepson in view of Close teaches
The catheter system of claim 9, wherein the housing is movable from a proximal position to a distal position, wherein in response to the housing moving from the proximal position to the distal position, the cannula extends through the septum and the fluid path through the connector is created [Jepson Col 1:45-52, 7:48-58, 8:56-9:6, Fig. 2].
Regarding claim 12, Jepson in view of Close teaches
The catheter system of claim 9, wherein the cannula extends through the septum [Jepson Col 7:48-58, Fig. 2].
Regarding claim 13, Jepson in view of Close teaches
The catheter system of claim 1, further comprising an extension set, wherein the extension set comprises a distal end coupled to the proximal end of the catheter adapter and a proximal end coupled to the connector [See § 103 modification of claim 1 above; blood collection lumen 150 (see Close Figs. 11-13 and 16)], wherein the connector is a needleless connector [Jepson Fig. 2].
Regarding claim 35, Jepson in view of Close teaches
The catheter system of claim 1, wherein the needle assembly comprises a body [See § 103 modification of claim 1 above; tube holder 30 (Close Fig. 4)], a sharp needle extending proximally from the body [See § 103 modification of claim 1 above; needle 34 (Close Fig. 4)], and a sheath covering a proximal tip of the sharp needle See § 103 modification of claim 1 above; elastomeric cover 35 (Close Fig. 4), and wherein the housing is coupled to a distal end of the body [wherein as depicted in Jepson Fig. 2, the locking flange 20 extends distally from the end of syringe 24, which as modified in the § 103 modification of claim 1 above is a blood collection set as disclosed by Close].
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jepson in view of Close, as applied to claim 1 above, in further view of Noble (US-20090156963-A1, previously presented).
Regarding claim 2, Jepson in view of Close teaches
The catheter system of claim 1, wherein the housing is directly coupled to the needle assembly [See § 103 modification of claim 1, above; FIG. 22 also shows the collection tube penetration needle 136 that is coupled to the tube holder 120 (Close ¶0132, Fig. 22)].
However, Jepson in view of Close fails to explicitly disclose wherein the housing is further removably coupled to the needle assembly.
Noble discloses a blood collection set comprising a needle assembly [transfer needle 34 (Noble Fig. 3)] and a housing [retaining structure 20 (Noble Fig. 3)], wherein the housing is directly and removably coupled to the needle assembly [transfer needle 34 and patient needle 16 or the one-piece needle equivalent may be secured to a needle hub which is received by and attached to hub 14 (Noble ¶0028)].
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 Jepson in view of Close to employ wherein the housing is removably coupled to the needle assembly, as this modification would amount to merely applying a known technique [removable coupling between a housing and a needle assembly] to a known device (method, or product) ready for improvement to yield predictable results [define a blood collection set comprising a needle assembly] MPEP § 2143(I)(D)].
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jepson in view of Close, as applied to claim 1 above, in further view of Howes (US-4072146-A, previously presented).
Regarding claim 4, Jepson in view of Close teaches
The catheter system of claim 1, further comprising:
a side port disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter [See § 103 modification of claim 1 above; wherein the catheter head body 202 (see Close ¶0117) as coupled to the blood collection lumen 150 (see Close Fig. 13) is considered to define a side port];
an extension tube, comprising a distal end integrated with the side port of the catheter adapter and a proximal end [See § 103 modification of claim 1 above; blood collection lumen 150 (Close Fig. 13); A blood collection channel 152 is defined in part by the passage defined by the space between the catheter 20 and microlumen 210, the passageway 250, and the lumen 150 (Close ¶0118, Fig. 13); Specifically, and referring to FIGS. 21 and 28, the blood collection channel 152, described in part above, is further defined by a blood collection passageway 194, including blood collection transfer orifice 195, and draw port 154 (Close ¶0127, Fig. 18)].
However, Jepson in view of Close fails to explicitly disclose another adapter, comprising a distal end and a port, wherein the connector is coupled to the port of the another adapter and wherein the proximal end of the extension tube is integrated with the distal end of the another adapter.
Howes discloses catheter systems, wherein Howes discloses the use of adapters to couple tubes and connectors [the proximate ends of lumens 19, 21, 23 extend beyond the proximate end of the catheter tube 18, and each is provided with an adapter 29, 31, 33, respectively, for attachment to a suitable device or fluid source. Adapter 29 is shown receiving one leg 32 of a flow control valve 35 which may, in turn, have another leg 37 receiving a fitting 34 fixed to one end of a conduit 36 for a central venous pressure (CVP) measuring device 39 (Howes Col 4:7-15, Fig. 1)], wherein Howes is considered to depict an extension tube [lumen 19 (Howes Fig. 1)] comprising a distal end integrated with a port of a catheter adapter and a proximal end coupled to a connector [leg 32 of flow control valve 35 (Howes Fig. 1)] via another adapter comprising a distal end and a port [adapter 29 (Howes Fig. 1)], wherein the connector is coupled to the port of the another adapter and wherein the proximal end of the extension tube is integrated with the distal end of the another adapter [Howes Fig. 1, wherein the end of the adapter 29 coupled to leg 32 of flow control valve 35 (connector) is considered to define the port of the adapter, and wherein the end opposite the port of the adapter is considered to define the distal end of the adapter that is integrated with a proximal end of the extension tube].
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 Jepson in view of Close to employ another adapter, comprising a distal end and a port, wherein the connector is coupled to the port of the another adapter and wherein the proximal end of the extension tube is integrated with the distal end of the another adapter, as this modification would amount to mere simple substitution of one known element for another with similar expected results [provide coupling between a catheter adapter and a connector to define a fluid pathway] [MPEP § 2143(I)(B)].
Regarding claim 5, Jepson in view of Close and Howes teaches
The catheter system of claim 4, wherein the another adapter comprises a Y-adapter or a straight adapter [wherein adapter 29 (Howes Fig. 1) is considered to define a straight adapter].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jepson in view of Close, as applied to claim 6 above, in further view of Bejhed (US-20190275316-A1, previously presented).
Regarding claim 8, Jepson in view of Close teaches
The catheter system of claim 6.
However, while Jepson discloses that the penetration member 12 defining a housing of the blood collection set is a male luer [As can be appreciated, when the male luer tip 18 extends within the connector 10 and the locking flange 20 extends about the exterior of the connector, the size of the connector and its components are constrained within the spacing between the luer tip and locking flange (Jepson Col 8:62-67, Fig. 2)], Jepson in view of Close fails to explicitly disclose wherein the housing comprises a distal piece and a proximal piece movable distally towards the distal piece, wherein the distal piece of the housing comprises a male luer, wherein the male luer is configured to activate the septum and create the fluid path through the connector in response to the proximal piece moving distally towards the distal piece.
Bejhed discloses systems for transferring fluid, wherein Bejhed discloses a housing comprising a distal piece [first housing 110 (Bejhed Fig. 2a), wherein the Examiner notes that tube portion 140 of first housing 110 of Bejhed is structurally similar to the penetration member 12 of Jepson Fig. 2] and a proximal piece [second housing 200 (Bejhed Fig. 2a), wherein the Examiner notes that the first housing 110 is depicted (Fig. 2a) as extending distally beyond the second housing 200, such that the first housing 110 may read on the “distal” piece and the second housing 200 may read on the “proximal” piece] movable distally towards the distal piece, wherein the distal piece of the housing comprises a male connector [tube portion 140 (Bejhed Fig. 2c)], wherein the male connector is configured to couple to a connector [third housing 300 (Bejhed Fig. 2a)] comprising a septum [sealing element 320 (Bejhed Fig. 2a)] and activate the septum and create a fluid path through the connector in response to the proximal piece moving distally towards the distal piece [During the movement of the second housing 200 (and the third housing 300) from the first, extracted position to the second, retracted position of the second housing, the tube portion 140 of the first housing 110 gradually projects through the first sealing element 220 and the second sealing element 320 for connection with the channel 310 for enabling a transfer of fluid through the coupling device 100 (Bejhed ¶0060, Fig. 2c); The tube portion 140 projects or penetrates through the first sealing element 220 and the second sealing element 320. Furthermore, the tube portion 140 becomes fittingly inserted and debouches into the channel 310 of the third housing 300. In this configuration of the coupling device 100, a transfer of fluid through the coupling device 100 is enabled (Bejhed ¶0061, Fig. 2d); see each of Bejhed Figs. 2a-d].
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 Jepson in view of Close to employ wherein the housing comprises a distal piece and a proximal piece movable distally towards the distal piece, wherein the distal piece of the housing comprises a male luer, wherein the male luer is configured to activate the septum and create the fluid path through the connector in response to the proximal piece moving distally towards the distal piece, so as to prevent any leakage in the event of a disconnection between the housing and the connector [In other words, the respective first and second sealing elements may conveniently stop a flow on either side of the respective sealing elements upon disconnection/detachment of the coupling device. Hence, the coupling device of the present invention may provide excellent sealing properties and avoid leakage (Bejhed ¶0007)], as well as this modification amounting to mere simple substitution of one known element for another with similar expected results [define a fluid pathway between a blood collection set and a connector] [MPEP § 2143(I)(B)].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jepson in view of Close, as applied to claim 9 above, in further view of Frazier (US-20080200837-A1, previously presented).
Regarding claim 10, Jepson in view of Close teaches
The catheter system of claim 9.
However, Jepson in view of Close fails to explicitly disclose wherein the cannula comprises a side hole in fluid communication with a lumen of the cannula.
Frazier discloses a fluid sampling system, wherein Frazier discloses a housing [front fitting 198 (Frazier Fig. 6)] configured to couple to a connector comprising a septum [elastomeric seal 140 of rigid housing 130 (Frazier Fig. 6), wherein the Examiner notes that while Frazier Fig. 6 does expressly identify rigid housing 130, the rigid housing 130 is understood to be depicted in Fig. 6 (see Frazier ¶0069 regarding rigid housing 130)], wherein the housing comprises a cannula configured to penetrate the septum of the connector to create the fluid path through the connector [The bypass probe 194 is shown piercing the elastomeric seal 140 of the sampling site to enter the chamber 136… Because of one or more side openings 196 in the bypass probe 194, an inner throughbore (not shown) of the bypass cannula 190 opens to the chamber 136 within the sampling site. Inner threads on a front fitting 198 of the bypass cannula 190 mate with external threads formed on the sampling port 138 of the sampling site (Frazier ¶0075, Fig. 6)]; and wherein the cannula comprises a side hole in fluid communication with a lumen of the cannula [side openings 196 (Frazier ¶0075, Fig. 6)].
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 Jepson in view of Close to employ wherein the cannula comprises a side hole in fluid communication with a lumen of the cannula, as this modification would amount to mere simple substitution of one known element for another with similar expected results [define a fluid pathway between a penetrating cannula and a connector] [MPEP § 2143(I)(B)].
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jepson in view of Close, as applied to claim 1, in further view of Steyn (US-6468249-B1) and Rosenberg (US-20130218127-A1).
Regarding claim 34, Jepson in view of Close teaches
The catheter system of claim 1.
However, Jepson in view of Close fails to explicitly disclose wherein the housing is directly and removably coupled to the needle assembly via engagement between a proximal luer of the housing and a body of the needle assembly, with the blood collection set in a first configuration when the needle assembly is connected to the housing and in a second configuration when the needle assembly is removed from the housing, and wherein the needle assembly of the blood connection set is configured to receive a blood collection device when the blood collection set is in the first configuration and the proximal luer is configured to couple to an infusion device when the blood collection set is in the second configuration.
Steyn discloses systems for blood collection, wherein Steyn discloses a blood collection set comprising a housing [end wall 114 (Steyn Figs. 3-5), wherein the Examiner notes that the end wall 114 defines a luer connection at a distal end for coupling to a vascular access device (Steyn Col 4:28-29), similar to the connection between the upper end 30 and penetrating member 12 of Jepson (see Jepson Fig. 2)] and a needle assembly [inner needle 128 (Steyn Figs. 3-5)], wherein the housing is directly and removably coupled to the needle assembly via engagement between a proximal luer of the housing and a body of the needle assembly [Accordingly, the device 110 includes an inner needle 128 connected to the formation 116 by means of a Luer Slip attachment 130 (Steyn Col 4:26-28, Figs. 3-5)], with the blood collection set in a first configuration when the needle assembly is connected to the housing and in a second configuration when the needle assembly is removed from the housing [wherein the inner needle 128 being operatively connected via a luer slip is considered to define a removable connection, such that the luer connection defines a connected first configuration and a disconnected second configuration], and wherein the needle assembly of the blood connection set is configured to receive a blood collection device when the blood collection set is in the first configuration [when the vacuum vial 18 is fully inserted into the socket 14, the needle 32 punctures the stopper 52 and the sheath 36 is driven away from the point of this needle by the stopper, thereby exposing the point of the needle. As soon as the needle 32 penetrates the stopper 52 and enters the vial 18, the pressure differential across the needles 32 and 38 causes blood in the patient's blood stream to be drawn through the needles and into the vial (Steyn Col 3:58-65, Figs. 1-2)].
Rosenberg discloses catheter systems, wherein Rosenberg discloses a proximal luer that is configured to couple to either a blood collection device or an infusion device [the fluid fitting 117 may provide a luer connector, which includes a threaded region and a sealing face at the proximal-most end region of the proximal connector hub 115, for purposes of detachably coupling to an external fluid line (e.g., a supply of intravenous fluid, a medicine delivery line, a blood infusion line, a blood withdrawal line, or the like) (Rosenberg ¶0026)].
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 Jepson in view of Close to employ wherein the housing is directly and removably coupled to the needle assembly via engagement between a proximal luer of the housing and a body of the needle assembly, with the blood collection set in a first configuration when the needle assembly is connected to the housing and in a second configuration when the needle assembly is removed from the housing, and wherein the needle assembly of the blood connection set is configured to receive a blood collection device when the blood collection set is in the first configuration, as this modification would amount to mere simple substitution of one known element for another with similar expected results [define a fluid pathway between a housing of a blood collection set and a needle operably coupled to a blood collection device] [MPEP § 2143(I)(B)]; and to have further modified the system of Jepson in view of Close and Steyn to employ wherein the proximal luer is configured to couple to an infusion device when the blood collection set is in the second configuration, 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 [use of a luer connection to define a fluid pathway between a vascular system of a subject with a blood collection set or an infusion device] [MPEP § 2143(I)(D)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 26 March 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objections for reference characters not mentioned in the description and reference characters not included in the drawings overcome have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7, with respect to the previously presented specification objection(s) have been fully considered and are persuasive. The specification objection for incorporation by reference to a foreign reference overcome has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously applied rejection of claim 4 under § 112(b) have been fully considered and are persuasive. The rejection of claim 4 under § 112(b) has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under Non-Statutory Double Patenting Obviousness-type Provisional Rejection 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 copending Application No. 18/725,207, hereinafter Hu, in view of Jepson (US-6261282-B1).
The Applicant asserts that the amendments to claim 1 render claim 1 patentably distinct from that which is disclosed I claims 1-6, 9-11, and 14 of U.S. Application No. 18/725,207 (Hu), as the conflicting claims do not teach or suggest the amended subject matter of instant claim 1. 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. Conflicting patent application Hu is further modified by Jepson (US-6261282-B1), which is considered to teach the amended limitations of claim 1 [Jepson Col 7:35-43, 7:60-64, Figs. 1-2, wherein as depicted in Jepson Fig. 2, the upper end 30 (proximal end) and the septum 28 (septum) are positioned within the locking flange 20 of the housing formed by penetrating member 12 when the connector 10 (connector) is coupled to the penetrating member 12 (structurally defines a housing)].
Applicant’s arguments, see Applicant’s Remarks p. 8-12, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 102 and § 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 Jepson (US-6261282-B1) in view of Close (US-20140188002-A1, previously presented).
Regarding claim 1, the Applicant asserts that the previously presented Close reference fails to teach or disclose the amended limitations regarding “a connector coupled the catheter adapter and comprising a proximal end including a septum” along with a blood collection set comprising a needle assembly and a housing “wherein the housing is coupled to the connector and configured to create a fluid path through the connector such that, with the housing coupled to the connector, the proximal end of the connector and the septum are positioned within the housing”, as the Applicant notes that needless draw port 154 of Close cannot be considered to be provided at a proximal end of transfer valve housing 142 [taken to read to read on the connector] and with the tube holder 120 of Close [taken to read on the claimed housing] coupled to the transfer valve housing 142, a proximal end of the transfer valve housing 142 and the valve 182 and/or valve layer 190 [taken to read on the claimed septum] cannot be considered to be positioned within the housing tube holder 120. 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. Jepson (US-6261282-B1) in view of Close (US-20140188002-A1, previously presented) is presently applied to teach the argued amended limitations [Jepson Col 7:35-43, 7:60-64, Figs. 1-2, wherein as depicted in Jepson Fig. 2, the upper end 30 (proximal end) and the septum 28 (septum) are positioned within the locking flange 20 of the housing formed by penetrating member 12 when the connector 10 (connector) is coupled to the penetrating member 12 (structurally defines a housing)].
Regarding new claim 34, the Applicant asserts that the tube holder 120 of Close fails to teach the structure and functionality of the blood collection set as claimed in claim 34. 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. Jepson (US-6261282-B1) in view of Close (US-20140188002-A1, previously presented), Steyn (US-6468249-B1), and Rosenberg (US-20130218127-A1) is presently applied to teach the argued subject matter [Steyn Col 3:58-65, 4:26-28, Figs. 1-5; Rosenberg ¶0026].
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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