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
This office action is responsive to the amendment filed on 3/10/26. As directed by the amendment: claims 1, 2, 11, 16, and 17 have been amended, claims 3 and 18 have been cancelled, and no new claims have been added. Thus, claims 1, 2, 4-17, 19, and 20 are presently pending in this application.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) from the prior action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4-17, 19, and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding independent claims 1, 11, and 16, there is insufficient written description for the newly recited limitation of “a molded bellows structure” in the original disclosure, which constitutes new matter.
The remaining claims inherit the deficiencies of their respective parent independent claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 4-17, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink et al. (US 20210196167) in view of Burkholz et al. (US 20210212618) and Bullington et al. (US 20180140240).
Regarding claim 1, Vandenbrink et al. discloses a system (Fig. 2B, system 200), comprising: a container assembly (Fig. 2B, container assembly 210) comprising a cap (Fig. 2B, cap 212) and defining a reservoir (Fig. 2B, reservoir 211), the container assembly (Fig. 2B, container assembly 210) having a first end (Fig. 2B, cap 12 defines a first end; para. [0052]) and a second end (Fig. 2B, closed end 216), the cap (Fig. 2B, cap 212) disposed at the first end (Fig. 2B, the defined first end) of the container assembly (Fig. 2B, container assembly 210); a fluid access assembly (Fig. 2B, fluid access assembly 220) comprising a housing (Fig. 2B, housing 228) defining an interior (Fig. 2B, interior 221), a fluid access component (Fig. 2B, fluid access component 224), a fluid connector component (Fig. 2B, fluid connector component 226), and an engagement feature (Fig. 2B, engagement feature 222), the housing (Fig. 2B, housing 228) having a first end (Fig. 2B, first end 223) and a second end (Fig. 2B, second end 225), the fluid access component (Fig. 2B, fluid access component 224; para. [0054]) extending from the first end (Fig. 2B, first end 223) of the housing (Fig. 2B, housing 228) into the interior (Fig. 2B, interior 221) of the housing (Fig. 2B, housing 228), the fluid access component (Fig. 2B, fluid access component 224) defining a lumen (Fig. 2B, the fluid access component 224 includes a needle defining a lumen; para. [0054]), a connection portion (tubing of the patient access device defines a connection portion; para. [0102]), the fluid connector component (Fig. 2B, fluid connector component 226; para. [0055]) disposed on the first end (Fig. 2B, first end 223) of the housing (Fig. 2B, housing 228); and an adapter (Fig. 2B, adapter 230) including a first engagement feature (Fig. 2B, first engagement feature 231) and a second engagement feature (Fig. 2B, second engagement feature 232), the first engagement feature (Fig. 2B, first engagement feature 231) of the adapter (Fig. 2B, adapter 230) configured to releasably engage (Fig. 2B, the first engagement feature 231 is configured to releasably engage with the cap 212; para. [0052]) with the cap (Fig. 2B, cap 212) of the container assembly (Fig. 2B, container assembly 210) and the second engagement feature (Fig. 2B, second engagement feature 232) i of the adapter (Fig. 2B, adapter 230) configured to releasably engage (Fig. 2B, the second engagement feature 232 is configured to releasably engage with the engagement feature 222; para. [0052]) with the engagement feature (Fig. 2B, engagement feature 222) of the fluid access assembly (Fig. 2B, fluid access assembly 220) such that, in a first configuration in which the first engagement feature (Fig. 2B, first engagement feature 231) of the adapter (Fig. 2B, adapter 230) is engaged with the cap (Fig. 2B, cap 212) and the second engagement feature (Fig. 2B, second engagement feature 232) of the adapter (Fig. 2B, adapter 230) is engaged with the engagement feature (Fig. 2B, engagement feature 222) of the fluid access assembly (Fig. 2B, fluid access assembly 220), the cap (Fig. 2B, cap 212) of the container assembly (Fig. 2B, container assembly 210) is at least partially disposed within the interior (Fig. 2B, interior 221) of the housing (Fig. 2B, housing 228) and spaced from the fluid access component (Fig. 2B, Fig. 2B, Figs. 2F-21, in a first configuration, when the first engagement feature 231 of the adapter 230 is engaged with the cap 212 and the second engagement feature 232 is engaged with the gag engagement feature 222 of the fluid access assembly 220, the cap 212 is spaced away from the fluid access component 224 and the cap 212 is at least partially disposed within the housing 228; para. [0060]). Vandenbrink et al. does not explicitly disclose a connection portion having a distal end and a proximal end, the connection portion comprising a fluid path member, wherein the fluid path member comprises a compact connector, the compact connector comprising a proximal connector portion configured to couple the compact connector the fluid connector component, a distal connector portion configured to couple the compact connector to an access port of a vascular access device, and a central portion, wherein the central portion comprises a tube and a molded bellows structure disposed within the tube and defining a fluid path such that the central portion is shaped and configured to reduce hemolysis of a blood sample passing therethrough.
However, Burkholz et al. is in the field of an extension set for vascular access (para. [0007]) and teaches a system (Fig. 2, extension set 100 and PIVC 200 define a system), comprising a connection portion (Fig. 1A, extension set 100) having a distal end (Fig. 1A, distal end 100a) and a proximal end (Fig. 1A, proximal end 100b), the connection portion (Fig. 1A, extension set 100) comprising a connector interface (Fig. 1A, distal connector 110) disposed at the distal end (Fig. 1A, distal end 100a) and a fluid path member (Fig. 1A, extension tube 120) fluidly coupled to the connector interface (Fig. 1A, distal connector 100) and configured to be coupled to the fluid connector component of the fluid access assembly (Fig. 2, extension tube 120 is coupled to a fluid connector component of vacuum tube receiver 220 via connector 130; para. [0029]-[0030]; para. [0040]; para. [0047]), wherein the fluid path member (Fig. 1A, extension tube 120) is configured to reduce hemolysis of a blood sample passing therethrough (Fig. 1A, the configuration of extension tube 120 is optimized to minimize hemolysis while providing adequate flow rate; para. [0031]), and wherein the connection portion (Fig. 1A, extension set 100) comprises a compact connector (Fig. 1A, Fig. 2, extension set 100 defines a compact connector), the compact connector (Fig. 1A, Fig. 2, the defined compact connector) comprising a proximal connector portion (Fig. 1A, proximal connector 130) configured to couple the compact connector (Fig. 1A, Fig. 2, the defined compact connector) to the fluid connector component (Fig. 1A, Fig. 2, proximal connector 130 is configured in any form that would enable another device, such as vacuum tube 220, to be connected to extension set 100; para. [0030]; para. [0038]; para. [0040]), a distal connector portion (Fig. 1A, distal connector 110) 10) configured to couple the compact connector (Fig. 1A, Fig. 2, the defined compact connector) to an access port of a vascular access device (Fig. 1A, Fig. 2, distal connector 110 is configured in any form that would enable it to be coupled to a vascular access device; para. [0030]), and a central portion (Fig. 1A, extension tube 120) shaped and configured to reduce hemolysis of a blood sample passing therethrough (Fig. 1A extension tube 120 is optimized to minimize hemolysis while providing adequate flow rate; para. [0031]; para. [0050]-[0051]). Bullington et al. further teaches optimizing a tube 1250, similar to element 120 of Vandenbrink et al., for hemolysis by utilizing a bellows shape (see fig. 25; para. [0134-0136]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vandenbrink et al. to include an extension set including an inner tube 120 as taught by Burkholz et al., further modified with a bellows shape as taught by Bullington et al., the motivation being to minimize hemolysis (Burkholz et al., para. [0031]; Bullington et al., para. [0136]), thereby minimizing sample damage during collection.
Regarding claim 2, modified Vandenbrink et al. discloses the system of claim 1. Vandenbrink et al. does not explicitly disclose wherein the fluid path member comprises a flexible tube. However, Burkholz et al. is in the field of an extension set for vascular access (para. [0007]) and teaches a system (Fig. 2, extension set 100 and PIVC 200 define a system), wherein the fluid path member comprises a flexible tube (Fig. 1A, element 140). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vandenbrink et al. to include a tube as taught by Burkholz et al., the motivation being to allow selective access to tube 120 while also shielding from exposure to blood or other fluids (Burkholz et al., para. [0038]).
Regarding claim 4, modified Vandenbrink et al. discloses the system of claim 1. Vandenbrink et al. does not explicitly disclose wherein the connector interface comprises one of a threaded luer, a slip luer, a threaded luer lock with collar, a blunt plastic cannula, a male luer, a cannula for PRN access,aneedle-free connector, or a needle access cannula. However, Burkholz et al. is in the field of an extension set for vascular access (para. [0007]) and teaches a system (Fig. 2, extension set 100 and PIVC 200 define a system), wherein the connector interface (Fig. 1A, distal connector 110) comprises one of a threaded luer, a slip luer, a threaded luer lock with collar, a blunt plastic cannula, a male luer, a cannula for PRN access, a needle-free connector, or a needle access cannula (Fig. 1A, distal connector 110 is configured in any form, includinga blunt cannula snap connect, athreated male luer, asslip luer: para. [0030]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vandenbrink et al. to include connector as taught by Burkholz et al., the motivation being to facilitate connection to a vascular access device (Burkholz et al., para. [0030]).
Regarding claim 5, modified Vandenbrink et al. discloses the system of claim 1. Regarding wherein the fluid component connector is integrated with the fluid access assembly, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the fluid component connector to be integrated with the fluid access assembly, since the use of a one piece construction would have required only routine skill in the art. The motivation for doing so would have been to minimize part shifting and simplify manufacture.
Regarding claim 6, modified Vandenbrink et al. discloses the system of claim 1. Regarding wherein the fluid component connector is removably coupled to the fluid access assembly, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the fluid component connector to be removably coupled to the fluid access assembly, since separating parts involves only routine skill in the art. The motivation for doing so would have been to facilitate sterilization of parts.
Regarding claim 7, modified Vandenbrink et al. discloses the system of claim 1, Vandenbrink et al. further disclosing wherein the container assembly (Fig. 2B, container assembly 210) is configured to be transitioned from the first configuration to a second configuration (Fig. 2G, the system 200 is transitioned from the firsts configuration to a second configuration; para. [0061]) via translating the container assembly (Fig. 2B, container assembly 210) toward the first end (Fig. 2B, first end 223) of the fluid access assembly (Fig. 2B, fluid access assembly 220) such that the cap (Fig. 2B, cap 212) is disengaged from the first engagement feature (Fig. 2B, first engagement feature 231) of the adapter (Fig. 2B, the container assembly 210 is translated toward the first end 223 such that the cap 212 is engaged with the fluid access component 224 and the cap 212 is disengaged from the first engagement feature 231; para. [00611) and the fluid access component (Fig. 2B, Fig. 2G, pierces a resealable membrane of the cap (Fig. 2B, fluid access component 224 pierces a resealable membrane of the cap 212; para. [0053]-[0054]) such that the reservoir (Fig. 2G, reservoir 211) of the container assembly (Fig. 2G, container assembly 210) is in fluidic communication with the fluid connector component (Fig. 2B, Fig. 2G, fluid connector component 226) and the connection portion (the defined connection portion; para. [0102]) via the lumen of the fluid access component (Fig. 2B, Fig. 2G, the reservoir 211 is in fluidic communication with the fluid connector component 226 via the lumen of the fluid access component 224; para. [0061]).
Regarding claim 8, modified Vandenbrink et al. discloses the system of claim 1, Vandenbrink et al. further disclosing wherein the reservoir (Fig. 2B, reservoir 211) of the container assembly (Fig. 2B, container assembly 210) is evacuated (Fig. 2B, reservoir 211 is an evacuated reservoir; para. [0053]).
Regarding claim 9, modified Vandenbrink et al. discloses the system of claim 1, Vandenbrink et al. further disclosing wherein the engagement feature (Fig. 2B, engagement feature 222) of the fluid access assembly (Fig. 2B, fluid access assembly 220) includes a flange extending outward (Fig. 2B, engagement feature 222 includes a flange extending perpendicularly from a central axis of the housing 228; para. [0056]) relative to central axis (Fig. 2B, housing 228 defines a central axis) of the housing (Fig. 2B, housing 228) of the fluid access assembly (Fig. 2B, fluid access assembly 220).
Regarding claim 10, modified Vandenbrink et al. discloses the system of claim 1, Vandenbrink et al. further disclosing wherein the container assembly is a first container assembly (the container assembly is a first container assembly; para. [0106]), and further comprising a second container assembly (a second container assembly; para. [0106]) configured to be engaged with the fluid access component after removal of the first container assembly via translating the second container assembly toward the first end of the fluid access assembly such that a resealable membrane of the second container assembly is pierced by the fluid access component and a reservoir of the second container assembly is in fluidic communication with the fluid connector component via the lumen of the fluid access component (a second container assembly is translated toward the first end of the fluid access assembly such that a resealable membrane of the second container assembly is pierced by the fluid access component and a reservoir of the second container assembly is in fluidic communication with the fluid connector component via the lumen of the fluid access component; para. [0106]).
Regarding claim 11, Vandenbrink et al. discloses a method (Fig. 9, method 900; para. [0102]) of using a blood sample collection system em (Fig. 2B, system 200),comprising: providing the blood sample collection system (Fig. 2B, Fig. 9, system 200 is provided; para. [0102]), the system comprising: a container assembly (Fig. 2B, container assembly 210) comprising a cap (Fig. 2B, cap 212) and defining a reservoir (Fig. 2B, reservoir211), the container assembly (Fig. 2B, container assembly 210) having a first end (Fig. 2B, cap 12 defines a first end; para. [0052]) and a second end (Fig. 2B, closed end 216), the cap (Fig. 2B, cap 212) disposed at the first end (Fig. 2B, the defined first end) of the container assembly (Fig. 2B, container assembly 210); a fluid access assembly (Fig. 2B, fluid access assembly 220) comprising a housing (Fig. 2B, housing 228) defining an interior (Fig. 2B, interior 221),a fluid access component (Fig. 2B, fluid access component 224), a fluid connector component (Fig. 2B, fluid connector component 226), and an engagement feature (Fig. 2B, engagement feature 222), the housing (Fig. 2B, housing 228) having a first end (Fig. 2B, first end 223) and a second end (Fig. 2B, second end 225), the fluid access component (Fig. 2B, fluid access component 224; para. [0054]) extending from the first end (Fig. 2B, first end 223) of the housing (Fig. 2B, housing 228) into the interior (Fig. 2B, interior 221) of the housing (Fig. 2B, housing 228), the fluid access component (Fig. 2B, fluid access component 224) defining a lumen (Fig. 2B, the fluid access component 224 includes a needle defining a lumen; para. [0054]), the fluid connector component (Fig. 2B,fluid connector component 226; para. [0055]) disposed on the first end (Fig. 2B, first end 223) of the housing (Fig. 2B, housing 228), a connection portion (tubing off the patient access device defines a connection portion; para. [0102]), and an adapter (Fig. 2B, adapter 230) including a first engagement feature (Fig. 2B, first engagement feature 231) and a second engagement feature (Fig. 2B, second engagement feature 232), the first engagement feature (Fig. 2B, first engagement feature 231) of the adapter (Fig. 2B, adapter 230) configured to releasably engage (Fig. 2B, the first engagement feature 231 is configured to releasably engage with the cap 212; para. [0052]) with the cap (Fig. 2B, cap 212) of the container assembly (Fig. 2B, container assembly 210) and the second engagement feature (Fig. 2B, second engagement feature 232) of the adapter (Fig. 2B, adapter 230) configured to releasably engage (Fig. 2B, the second engagement feature 232 is configured to releasably engage with the engagement feature 222; para. [0052]) with the engagement feature (Fig. 2B, engagement feature 222) of the fluid access assembly (Fig. 2B, fluid access assembly 220) such that, in a first configuration in which the first engagement feature (Fig. 2B, first engagement feature 231) of the adapter (Fig. 2B, adapter 230) is engaged with the cap (Fig. 2B, cap 212) and the second engagement feature (Fig. 2B, second engagement feature 232) of the adapter (Fig. 2B, adapter 230) is engaged with the engagement feature (Fig. 2B, engagement feature 222) of the fluid access assembly (Fig. 2B. fluid access assembly 220), the cap (Fig. 2B, cap 212) of the container assembly (Fig. 2B, container assembly 210) is at least partially disposed within the interior (Fig. 2B, interior 221) of the housing (Fig. 2B, housing 228) and spaced from the fluid access component (Fig. 2B, Fig. 2B, Figs. 2F-21, in a first configuration, when the first engagement feature 231 of the adapter 230 is engaged with the cap 212 and the second engagement feature 232 is engaged with the engagement feature 222 of the fluid access assembly 220, the cap 212 is spaced away from the fluid access component 224 and the cap 212 is at least partially disposed within the housing 228; para. [0060]): translating the container assembly (Fig. 2B, container assembly 210) toward the first end (Fig. 2B, first end 223) of the fluid access assembly (Fig. 2B, fluid access assembly 220) and relative to the adapter (Fig. 2B, adapter 230) such that the cap (Fig. 2B, cap 212) is disengaged from the first engagement feature (Fig. 2B, first engagement feature 231) of the adapter (Fig. 2B, adapter 230) and the fluid access component (Fig. 2B, fluid access component 224) pierces a resealable membrane of the cap (Fig. 2B, fluid access component 224 pierces a resealable membrane of the cap 212; para. [0053]-[0054]) such that the reservoir (Fig. 2B, reservoir 211) of the container assembly (Fig. 2B. is in container assembly 210) is in fluidic communication with the fluid connector component (Fig. 2B, fluid connector component 226) via the lumen of the fluid access component (Fig. 2B, the system 200 is transitioned to a second configuration by translating the container assembly 210 toward the first end 223 of the fluid access assembly 220 such that the cap 212 is engaged with the fluid access component 224 and fluid is drawn through the fluid connector component 226, through the fluid access component 224, and into the reservoir 211: para. [0061]; para. [0103]); decoupling (Fig. 2B, Fig. 2H, the system 200 is transitioned to a third configuration in which the second engagement feature 232 of the adapter 230 is disengaged from the engagement feature 222; para. [0062]) the second engagement feature (Fig. 2B, second engagement feature 232) of the adapter (Fig. 2B, adapter 23) from the engagement feature (Fig. 2B, engagement feature 222) of the fluid access assembly (Fig. 2B, fluid access assembly 220); and translating the container assembly (Fig. 2B, container assembly 210) away from the first end (Fig. B, first end 223) of the fluid access assembly (Fig. 2B, fluid access assembly 220) and out of the interior (Fig. 2B, interior 221) of the fluid access assembly (Fig. 2B, fluid access assembly 220) such that the container assembly (Fig. 2B, container assembly 210) and the adapter (Fig. 2B, adapter 230) are separated from the fluid access assembly (Fig 2B, Fig. 21, the container assembly 210 is translated in the direction of arrow C such that the cap 212 is disengaged from the fluid access component 224 and the adapter 230 and container assembly 210 are decoupled from the fluid access assembly 220; para. [0063]). Vandenbrink et al. does not explicitly disclose a connection portion having a distal end and a proximal end, the connection portion comprising a fluid path member, wherein the fluid path member comprises a compact connector, the compact connector comprising a proximal connector portion configured to couple the compact connector the fluid connector component, a distal connector portion configured to couple the compact connector to an access port of a vascular access device, and a central portion, wherein the central portion comprises a tube and a molded bellows structure disposed within the tube and defining a fluid path such that the central portion is shaped and configured to reduce hemolysis of a blood sample passing therethrough, coupling the connector interface of the connection portion to a vascular access device.
However, Burkholz et al. is in the field of an extension set for vascular access (para. [0007]) and teaches a method (Fig. 2, method; para. [0047]), a system (Fig. 2, PIVC 200 and extension set 100 define a system) a connection portion (Fig. 1A, extension set 100) having a distal end 1A. (Fig. 1A, distal end 100a) and a proximal end (Fig. 1A, proximal end 100b), the connection portion (Fig. 1A, extension set 100) comprising a connector interface (Fig. 1A, distal connector 110) disposed at the distal end (Fig. 1A, distal end 100a) and a fluid path member (Fig. extension tube 120) fluidly coupled to the connector interface (Fig. 1A, distal connector 100) and configured to be coupled to the fluid connector component of the fluid access assembly (Fig. 2, extension tube 120 is coupled to a fluid connector component of vacuum tube receiver 220 via connector 130; para. [0029]-[0030]; para. [0040]; para. [0047]), wherein the fluid path member (Fig. 1A, extension tube 120) is configured to reduce hemolysis of a blood sample passing therethrough (Fig. 1A, the configuration of extension tube 120 is optimized to minimize hemolysis while providing adequate flow rate; para. [0031]), the method comprising coupling the connector interface (Fig. 1A, distal connector 110) of the connection portion (Fig. 1A, extension set 100) to a vascular access device (Fig. 1A, Fig. 2, distal connector 110 is coupled to a vascular access device; para. [0030]); the compact connector (Fig. 1A, Fig. 2, the defined compact connector) comprising a proximal connector portion (Fig. 1A, proximal connector 130) configured to couple the compact connector (Fig. 1A, Fig. 2, the defined compact connector) to the fluid connector component (Fig. 1A, Fig. 2, proximal connector 130 is configured in any form that would enable another device, such as vacuum tube 220, to be connected to extension set 100; para. [0030]; para. [0038]; para. [0040]), a distal connector portion (Fig. 1A, distal connector 110) 10) configured to couple the compact connector (Fig. 1A, Fig. 2, the defined compact connector) to an access port of a vascular access device (Fig. 1A, Fig. 2, distal connector 110 is configured in any form that would enable it to be coupled to a vascular access device; para. [0030]), and a central portion (Fig. 1A, extension tube 120) shaped and configured to reduce hemolysis of a blood sample passing therethrough (Fig. 1A extension tube 120 is optimized to minimize hemolysis while providing adequate flow rate; para. [0031]; para. [0050]-[0051]). Bullington et al. further teaches optimizing a tube 1250, similar to element 120 of Vandenbrink et al., for hemolysis by utilizing a bellows shape (see fig. 25; para. [0134-0136]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vandenbrink et al. to include an extension set including an inner tube 120 as taught by Burkholz et al., further modified with a bellows shape as taught by Bullington et al., the motivation being to minimize hemolysis (Burkholz et al., para. [0031]; Bullington et al., para. [0136]), thereby minimizing sample damage during collection.
Regarding claim 12, modified Vandenbrink et al. discloses the method of claim 11,Vandenbrink et al. further disclosing further comprising sterilizing the blood sample collection system (Fig. 2B, system 200) prior to coupling the connector interface of the connection portion to the vascular access device (Fig. 2B, the system 200 is sterilized in the first configuration and packaged for sterile transport to a user; para. [0060]; para. [0104]).
Regarding claim 13, modified Vandenbrink et al. discloses the t method of claim 11, Vandenbrink et al. further disclosing wherein decoupling the second engagement feature (Fig. 2B, second engagement feature 232) of the adapter (Fig. 2B, adapter 230) from the engagement feature (Fig. 2B, engagement feature 222) of the fluid access assembly (Fig. 2B, fluid access assembly 220) includes at least one of rotating (Fig. 2B, to disengage the adapter 230 from the fluid access assembly 220, the adapter 230 is rotatable relative to the fluid access assembly 220 such that the second engagement feature 232 is rotated out of engagement with the engagement feature 222; para. [0059]), unlatching, or deforming the adapter (Fig. 2B, adapter 230) relative to the housing (Fig. 2B, housing 228) of the fluid access assembly (Fig. 2B, fluid access assembly 220).
Regarding claim 14, modified Vandenbrink et al. discloses the method of claim 11, Vandenbrink et al. further disclosing wherein the container assembly is a first container assembly (the container assembly is a first container assembly; para. [0106]), the method further comprising: after translating the first container assembly away from the first end of the fluid access assembly and out of the interior of the fluid access assembly (after translating the first container assembly away from the first end of the fluid access assembly and out of the interior of the fluid access assembly; para. [0106]), translating a second container assembly toward the first end of the fluid access assembly such that a resealable membrane of the second container assembly is pierced by the fluid access component and a reservoir of the second container assembly is in fluidic communication with the fluid connector component via the lumen of the fluid access component (a second container assembly is translated toward the first end of the fluid access assembly such that a resealable membrane of the second container assembly is pierced by the fluid access component and a reservoir of the second container assembly is in fluidic communication with the fluid connector component via the lumen of the fluid access component; para. [0106]).
Regarding claim 15, modified Vandenbrink et al. discloses the method of claim 11, Vandenbrink et al. further disclosing wherein translating the container assembly (Fig. 2B, container assembly 210) toward the first end (Fig. 2B, first end 223) of the fluid access assembly (Fig. 2B, fluid access assembly 220) and relative to the adapter (Fig. 2B, adapter 230) such that the fluid access component (Fig. 2B, fluid access component 224) pierces a resealable membrane of the cap (Fig. 2B, fluid access component 224 pierces a resealable membrane of the cap 212; para. [0053]-[0054]) causes the reservoir (Fig. 2B, reservoir 211) to draw a blood sample (Fig. 2B, the system 200 is transitioned to a second configuration by translating the container assembly 210 toward the first end 223 of the fluid access assembly 220 such that the cap 212 is engaged with the fluid access component 224 and fluid is drawn through the fluid connector component 226, through the fluid access component 224, and into the reservoir 211; para. [0061]) from an indwelling vascular access device (patient access device; para. [0102]) through the fluid access component (Fig. 2B, fluid access component 224),and into the reservoir (Fig. 2B, reservoir 211) of the container assembly (Fig. 2B, container assembly 210) due to the reservoir (Fig. 2B, reservoir 211) of the container assembly (Fig. 2B, container assembly 210) being evacuated (Fig. 2B, reservoir 211 is an evacuated reservoir; para. [0053]). Vandenbrink et al. does not explicitly disclose the reservoir to draw a blood sample from an indwelling vascular access device fluidically coupled to the connection portion, through the fluid path member. However, Burkholz et al. is in the field of an extension set for vascular access (para. [0007]) and teaches a method (Fig. 2, method; para. [0047]), the reservoir (Fig. 2, vacuum tube 230 defines a reservoir) to draw a blood sample from an indwelling vascular access device (vascular access device; para. [0030]) fluidically coupled to the connection portion (Fig. 2, distal connector 110 is fluidically coupled to the vascular access device; para. [0030]), through the fluid path member (Fig. 1A, Fig. 2, fluid flows from the vascular access device through the distal connector 110 and through extension tube 120; para. [0030]; para. [0040]). Itwould have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Vandenbrink et al. to include connecting an extension set as taught by Burkholz et al., the motivation being to minimize hemolysis (Burkholz et al., para. [0031]), thereby minimizing sample damage during collection.
Regarding claim 16, Vandenbrink et al. discioses a system (Fig. 2B, system 200), comprising: a fluid access assembly (Fig. 2B, fluid access assembly 220) including a housing (Fig. 2B, housing 228) defining an interior (Fig. 2B, interior 221), a fluid access component (Fig. 2B, fluid access component 224), a fluid connector component (Fig. 2B, fluid connector component 226), and an engagement feature (Fig. 2B, engagement feature 222), the housing (Fig. 2B, housing 228) having a first end (Fig. 2B, first end 223) and a second end (Fig. 2B, second end 225), the fluid access component (Fig. 2B, fluid access component 224; para. [0054]) extending from the first end (Fig. 2B, first end 223) of the housing (Fig. 2B, housing 228) into the interior (Fig. 2B, interior 221) of the housing (Fig. 2B, housing 228), the fluid access component (Fig. 2B, fluid access component 224) defining a lumen (Fig. 2B, the fluid access component 224 includes a needle defining a lumen; para. [0054]), the fluid connector component (Fig. 2B, fluid connector component 226; para. [0055]) disposed on the first end (Fig. 2B, first end 223) of the housing (Fig. 2B, housing 228), and the engagement feature (Fig. 2B, engagement feature 222) of the fluid access assembly (Fig. 2B, fluid access assembly 220) disposed on the second end (Fig. 2B, second end 225) of the housing (Fig. 2B, housing 228); a container assembly (Fig. 2B, container assembly 210) including a cap (Fig. 2B, cap 212) and an engagement feature (Fig. 2B, ridges 218), the container assembly (Fig. 2B, container assembly 210) defining a reservoir (Fig. 2B, reservoir 211), the container assembly (Fig. 2B, container assembly 210) having a first end (Fig. 2B, cap 12 defines a first end; para. [0052]) and a second end (Fig. 2B, closed end 216), the cap (Fig. 2B, cap 212) disposed at the first end (Fig. 2B, the defined first end) of the container assembly (Fig. 2B, container assembly 210), the engagement feature (Fig. 2B, ridges 218; para. [0057]) of the container assembly (Fig. 2B, container assembly 210) configured toto releasably engage with engagement feature (Fig. 2B, ridges 218 engaged with engagement feature 222 via adapter 230; para. [0052]) of the fluid access assembly (Fig. 2B, fluid access assembly 220) such that, in a first configuration in which the engagement feature (Fig. 2B, ridges 218) of the container assembly (Fig. 2B, container assembly 210) is engaged with the engagement feature (Fig. 2B, engagement feature 222) of the fluid access assembly (Fig. 2B, fluid access assembly 220), the cap (Fig. 2A, Fig. 2B, cap 221) is at least partially disposed within the interior (Fig. 2B, interior 221) of the housing (Fig. 2B, housing 228) and spaced from the fluid access component (Fig. 2A, Fig. 2B, Figs. 2F-21, in a first configuration, ridges 218 are engaged with the first engagement feature 231, the second engagement feature 232 is engaged with the engagement feature 222 of the fluid access assembly 220 and the cap 212 is spaced away from the fluid access component 224 and the cap 212 is at least partially disposed within the housing 228; para. [0052]; para. [0057]; para. [0060]); and a connection portion (tubing of the patient access device defines a connection portion; para. [0102]). Vandenbrink et al. does not explicitly disclose a connection portion having a distal end and a proximal end, the connection portion comprising a fluid path member, wherein the fluid path member comprises a compact connector, the compact connector comprising a proximal connector portion configured to couple the compact connector the fluid connector component, a distal connector portion configured to couple the compact connector to an access port of a vascular access device, and a central portion, wherein the central portion comprises a tube and a molded bellows structure disposed within the tube and defining a fluid path such that the central portion is shaped and configured to reduce hemolysis of a blood sample passing therethrough.
However, Burkholz et al. is in the field of an extension set for vascular access (para. [0007]) and teaches a system (Fig. 2, extension set 100 and PIVC 200 define a system), comprising a connection portion (Fig. 1A, extension set 100) having a distal end (Fig. 1A, distal end 100a) and a proximal end (Fig. 1A, proximal end 100b), the connection portion (Fig. 1A, extension set 100) comprising a connector interface (Fig. 1A, distal connector 110) disposed at the distal end (Fig. 1A, distal end 100a) and a fluid path member (Fig. 1A, extension tube 120) fluidly coupled to the connector interface (Fig. 1A, distal connector 100) and configured to be coupled to the fluid connector component of the fluid access assembly (Fig. 2, extension tube 120 is coupled to a fluid connector component of vacuum tube receiver 220 via connector 130; para. [0029]-[0030]; para. [0040]; para. [0047]), wherein the fluid path member (Fig. 1A, extension tube 120) is configured to reduce hemolysis of a blood sample passing therethrough (Fig. 1A, the configuration of extension tube 120 is optimized to minimize hemolysis while providing adequate flow rate; para. [0031]), and wherein the connection portion (Fig. 1A, extension set 100) comprises a compact connector (Fig. 1A, Fig. 2, extension set 100 defines a compact connector), the compact connector (Fig. 1A, Fig. 2, the defined compact connector) comprising a proximal connector portion (Fig. 1A, proximal connector 130) configured to couple the compact connector (Fig. 1A, Fig. 2, the defined compact connector) to the fluid connector component (Fig. 1A, Fig. 2, proximal connector 130 is configured in any form that would enable another device, such as vacuum tube 220, to be connected to extension set 100; para. [0030]; para. [0038]; para. [0040]), a distal connector portion (Fig. 1A, distal connector 110) 10) configured to couple the compact connector (Fig. 1A, Fig. 2, the defined compact connector) to an access port of a vascular access device (Fig. 1A, Fig. 2, distal connector 110 is configured in any form that would enable it to be coupled to a vascular access device; para. [0030]), and a central portion (Fig. 1A, extension tube 120) shaped and configured to reduce hemolysis of a blood sample passing therethrough (Fig. 1A extension tube 120 is optimized to minimize hemolysis while providing adequate flow rate; para. [0031]; para. [0050]-[0051]). Bullington et al. further teaches optimizing a tube 1250, similar to element 120 of Vandenbrink et al., for hemolysis by utilizing a bellows shape (see fig. 25; para. [0134-0136]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vandenbrink et al. to include an extension set including an inner tube 120 as taught by Burkholz et al., further modified with a bellows shape as taught by Bullington et al., the motivation being to minimize hemolysis (Burkholz et al., para. [0031]; Bullington et al., para. [0136]), thereby minimizing sample damage during collection.
Regarding claim 17, modified Vandenbrink et al. discloses the system of claim 16. Vandenbrink et al. does not explicitly disclose wherein the fluid path member comprises a flexible tube. However, Burkholz et al. is in the field of an extension set for vascular access (para. [0007]) and teaches a system (Fig. 2, extension set 100 and PIVC 200 define a system), wherein the fluid path member (Fig. 1A, extension tube 120) comprises a flexible tube (Fig. 1A, Fig. 4, tube 120). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vandenbrink et al. to include a tube as taught by Burkholz et al., the motivation being to minimize hemolysis (Burkholz et al., para. [0031]), thereby minimizing sample damage during collection.
Regarding claim 19, modified Vandenbrink et al. discloses the system of claim 16, Vandenbrink et al. further disclosing wherein the container assembly (Fig. 2B, the container assembly 210) is configured to be transitioned from the first configuration to a second configuration via translating the container assembly (Fig. 2B, the container assembly 210) toward the first end (Fig. 2B, first end 223) of the fluid access assembly (Fig. 2B, fluid access assembly 220) such that the engagement feature (Fig. 2B, ridges 218) of the container assembly (Fig. 2B, the container assembly 210) is disengaged from the engagement feature (Fig. 2B, engagement feature 222) of the fluid access assembly (Fig. 2B, fluid access assembly 220) and the fluid access component (Fig. 2B, fluid access component 224) pierces a resealable membrane of the caр (Fig. 2B, Fig. 2F, Fig. 2G, fluid access component 224 pierces a resealable membrane of the cap 212; para. [0053]) such that the reservoir (Fig. 2B, reservoir 211) of the container assembly (Fig. 2B, the defined container assembly 210) is in fluidic communication with the fluid connector component (Fig. 2B, fluid connector component 226) and the connection portion (the defined connection portion; para. [0102]) via the lumen of the fluid access component (Fig. 2A, Fig. 2B, Figs. 2F-21, the system 200 is transitioned to a second configuration by translating the container assembly 210 toward the first end 223 such that the cap 212 is engaged with the fluid access component 224 and disengaged from the first engagement feature of the adapter, and the reservoir 211 is in fluid communication with the fluid connector component 226 via the lumen of the fluid access component 224; para. [0061]; para. [0103]).
Regarding claim 20, modified Vandenbrink et al. discloses the system of claim 16. Vandenbrink et al. does not explicitly disclose wherein the connector interface comprises one of a threaded luer, a slip luer, a threaded luer lock with collar, a blunt plastic cannula, a male luer, a cannula for PRN access, a needle-free connector, or a needle access cannula. However, Burkholz et al. is in the field of an extension set for vascular access (para. [0007]) and teaches a system (Fig. 2, extension set 100 and PIVC 200 define a system), wherein the connector interface (Fig. 1A, distal connector 110) comprises one of a threaded luer, a slip luer, a threaded luer lock with collar, a blunt plastic cannula, a male luer, a cannula for PRN access, a needle-free connector, or a needle access cannula (Fig. 1A, distal connector 110 is configured in any form, including a blunt cannula snap connect, a threated male luer, a slip luer: para. [0030]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vandenbrink et al. to include connector as taught by Burkholz et al., the motivation being to facilitate connection to a vascular access device (Burkholz et al., para. [0030]).
Response to Arguments
Applicant's arguments filed 3/10/26 have been fully considered but they are not persuasive. Specifically, applicant’s arguments directed to the newly amended limitations have been addressed by further modification with Bullington et al. above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Paspa (US 20140364815) discloses a molded bellows structure inside a flow path (for example, elements 22, 26, and 36 in fig. 5 and 6).
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.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783