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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/20/26 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 7/20/26. As directed by the amendment: claims 1, 5, 6, 11, and 16 have been amended, 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 11-15, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4, 11, and 20, “the connector interface” lacks antecedent basis. It is not clear how this limitation relates to any of the recited limitations in parent claim 1 or 16 (for claims 4 and 20, respectively, or any of the preceding limitations in claim 11.
Claims 12-15 are rejected as they depend from claim 11.
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, 4-16, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink et al. (US 20210196167) in view of Salehi Borojerdi et al. (US 20230309876; hereinafter “Salehi”).
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]), the fluid connector component 226 disposed on the first end of the housing (see fig. 2B);
a connection portion (tubing of 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 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 axial fluid path 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 as the blood sample flows through the tube and around the molded axial fluid path structure.
However, Salehi teaches a connection portion 100 (fig. 1-4) having a distal end (towards 110) and a proximal end (towards 122), the connection portion comprising a fluid path member (par. 0031), wherein the fluid path member comprises a compact connector (see fig. 2, comprised at least of 110 and 120), the compact connector comprising a proximal connector portion 120 configured to couple the compact connector the fluid connector component (see fig. 1, 42 being the equivalent fluid connector component; par. 0030), a distal connector portion 110 configured to couple the compact connector to an access port 90 of a vascular access device 50 (par. 0029), and a central portion (comprising at least 114, 130, 135, and 136), wherein the central portion comprises a tube 114 and a molded axial fluid path structure 130 disposed within the tube and defining a fluid path 135 (see fig. 2-4) such that the central portion is shaped and configured to reduce hemolysis of a blood sample passing therethrough as the blood sample flows through the tube and around the molded axial fluid path structure (par. 0032-0038). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vandenbrink et al. to utilize a connection portion as taught by Salehi for the purpose of reducing hemolysis (par. 0032-0038).
Regarding claim 4, as best understood, Salehi teaches the connector interface (interpreted as one or more of the proximal and/or distal connectors in claim 1) comprises a threaded luer (at least 110 in fig. 3; par. 0029).
Regarding claim 5, Vandenbrink et al. discloses the fluid connector component is integrated with the fluid access assembly (226 is integrated to 220 as assembled in fig. 1).
Regarding claim 6, Vandenbrink et al. discloses the fluid component connector is removably coupled to the fluid access assembly (par. 0055).
Regarding claim 7, Vandenbrink et al. discloses 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, Vandenbrink et al. discloses 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, Vandenbrink et al. discloses 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, Vandenbrink et al. discloses 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, as best understood, Vandenbrink et al. discloses a method (Fig. 9, method 900; para. [0102]) of using a blood sample collection system (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, 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]), the fluid connector component 226 disposed on the first end of the housing (see fig. 2B);
a connection portion (tubing of 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 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]);
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 axial fluid path 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 as the blood sample flows through the tube and around the molded axial fluid path structure, and coupling the connector interface of the connection portion to a vascular access device.
However, Salehi teaches a connection portion 100 (fig. 1-4) having a distal end (towards 110) and a proximal end (towards 122), the connection portion comprising a fluid path member (par. 0031), wherein the fluid path member comprises a compact connector (see fig. 2, comprised at least of 110 and 120), the compact connector comprising a proximal connector portion 120 configured to couple the compact connector the fluid connector component (see fig. 1, 42 being the equivalent fluid connector component; par. 0030), a distal connector portion 110 configured to couple the compact connector to an access port 90 of a vascular access device 50 (par. 0029), and a central portion (comprising at least 114, 130, 135, and 136), wherein the central portion comprises a tube 114 and a molded axial fluid path structure 130 disposed within the tube and defining a fluid path 135 (see fig. 2-4) such that the central portion is shaped and configured to reduce hemolysis of a blood sample passing therethrough as the blood sample flows through the tube and around the molded axial fluid path structure (par. 0032-0038), and coupling the connector interface of the connection portion (interpreted as one or more of the proximal and/or distal connectors in claim 1) to a vascular access device 50 (par. 0029). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vandenbrink et al. to utilize a connection portion as taught by Salehi for the purpose of reducing hemolysis (par. 0032-0038).
Regarding claim 12, Vandenbrink et al. discloses 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, Vandenbrink et al. discloses 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, Vandenbrink et al. discloses 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, Vandenbrink et al. discloses 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, Salehi teaches drawing a blood sample from an indwelling vascular access device (PIVC 10, fig. 1; par. 0021-0025) fluidically coupled to the connection portion (via connection between 90 and 110; see fig. 1), through the fluid path member (par. 0032-0038). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vandenbrink et al. as taught by Salehi for the purpose of providing sufficient structure to achieve Vandenbrink et al.’s disclosed intended purpose of drawing/sampling blood.
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 axial fluid path 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 as the blood sample flows through the tube and around the molded axial fluid path structure.
However, Salehi teaches a connection portion 100 (fig. 1-4) having a distal end (towards 110) and a proximal end (towards 122), the connection portion comprising a fluid path member (par. 0031), wherein the fluid path member comprises a compact connector (see fig. 2, comprised at least of 110 and 120), the compact connector comprising a proximal connector portion 120 configured to couple the compact connector the fluid connector component (see fig. 1, 42 being the equivalent fluid connector component; par. 0030), a distal connector portion 110 configured to couple the compact connector to an access port 90 of a vascular access device 50 (par. 0029), and a central portion (comprising at least 114, 130, 135, and 136), wherein the central portion comprises a tube 114 and a molded axial fluid path structure 130 disposed within the tube and defining a fluid path 135 (see fig. 2-4) such that the central portion is shaped and configured to reduce hemolysis of a blood sample passing therethrough as the blood sample flows through the tube and around the molded axial fluid path structure (par. 0032-0038). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vandenbrink et al. to utilize a connection portion as taught by Salehi for the purpose of reducing hemolysis (par. 0032-0038).
Regarding claim 19, Vandenbrink et al. discloses 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, as best understood, Salehi teaches the connector interface (interpreted as one or more of the proximal and/or distal connectors in claim 1) comprises a threaded luer (at least 110 in fig. 3; par. 0029).
Claim(s) 2 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink et al. in view of Salehi, and further in view of Burkholz et al. (US 20210212618).
Regarding claims 2 and 17, Vandenbrink et al. does not explicitly disclose wherein the fluid path member comprises a flexible tube. However, Burkholz et al. teaches a fluid path member that comprises a flexible tube (Fig. 1A, element 140; par. 0032). 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. in view of Salehi to utilize a flexible tube, as taught by Burkholz et al., for the purpose of allowing selective component access while also shielding from exposure to blood or other fluids (par. 0038).
Response to Arguments
Applicant's arguments filed 7/20/26 have been fully considered and are persuasive as directed to the amendments made to the independent claims vs. the prior 103 rejection over Vandenbrink, Burkholz, and Bullington. In response, new grounds of rejection are presented above utilizing Vandenbrink et al. in view of Salehi, which address the amended limitations of the independent claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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