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 .
Claim Objections
The Claims are objected to because of the following informalities:
In Claim 7, lines 5-6, the term “wherein the flexible tube ‘is configured to reduce hemolysis of a blood sample passing therethrough” should be replaced with -- wherein the flexible tube [[‘is]] is configured to reduce hemolysis of a blood sample passing therethrough -- to address a typographical error.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink et al (US 2021/0196167) (“Vandenbrink”) as noted in Applicant IDS dated 4/28/2025 in view of Okman et al (US 2021/0008237) (“Okman”).
Regarding Claim 1, while Vandenbrink teaches a system (Abstract, Figs. 1-2B, [0039]-[0059]), comprising:
a container assembly comprising a cap and defining a reservoir, the container assembly having a distal end and a proximal end, the cap disposed at the distal end of the container assembly (Fig. 1, [0039]-[0040], Fig. 2B, [0052] container assembly 210 comprises a cap 212 and tube 214 defining a reservoir 211, the container assembly having a distal end and a proximal end 216, the cap 212 disposed at the distal end of the container assembly 210);
a fluid access assembly comprising a housing defining an interior, a fluid access component, and a fluid connector component (Fig. 1, [0039]-[0040], Fig. 2B, [0052] fluid access assembly 220 comprises a housing 228 defining an interior 221, a fluid access component 224, and a fluid connector component 226), the housing having a distal end and a proximal end, the fluid access component extending from the distal end of the housing into the interior of the housing ([0054] distal end 223, proximal end 225, fluid access component 224 reflect this relationship), the fluid access component defining a lumen, the fluid connector component disposed on the distal end of the housing ([0054] a fluid access component 224 defines a lumen by a needle, the fluid connector component 226 is disposed on the distal end of the housing 223);
and further teaches that the system can be configured for transport in a sterile manner ([0060]),
Vandenbrink fails to teach the system comprising a scrubbing cap provided at or adjacent a distal end of the fluid access assembly, the scrubbing cap comprising:
A scrubbing insert; and
a housing defining a cavity configured to retain the scrubbing insert therein.
However Okman teaches a disinfection device for fluid accessing systems (Abstract) that comprises a scrubbing cap to interface with a luer connector (Abstract, [0011], [0017], [0047]-[0048], [0051]-[0052] scrubbing element for disinfecting a luer connector, [0043] where at least a portion of the system may be housed within a cap), the scrubbing cap comprising:
A scrubbing insert ([0011], [0017], [0035]-[0036], [0048] scrubbing element 110); and
a housing defining a cavity configured to retain the scrubbing insert therein ([0041], [0043], [0051]-[0052] container houses the scrubbing components, indicating a cavity to retain scrubbing element within).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the scrubbing cap of Okman to the fluid access assembly of Vandenbrink as Okman teaches that fluid connector component are susceptible to contamination (Abstract, [0003]), for example luer connectors. And Vandebrink distal end is a fluid connector, and specifically, a luer connector ([0055]). Thus Okman is providing a remedy for this susceptibility by interfacing the susceptible luer connector with a device to maintain sterility, a goal of Vanderbrink ([0060]).
Regarding Claim 2, Vandenbrink and Okman teach the system of claim 1, wherein the fluid connector component comprises a luer connector configured to be coupled to an access port of a vascular access device ([0055] fluid connector component 226 can be a luer connector, luer connectors are configured to be coupled to an access port of a vascular access device), and wherein the scrubbing cap comprises a connector portion configured to engage with the luer connector to secure the scrubbing cap to the fluid access assembly (See Claim 1 Rejection, Okman [0047] threading portion and sidewalls of scrub element can engage with luer connectors for secure contact).
Regarding Claim 3, Vandenbrink and Okman teach the system of claim 2, wherein the luer connector comprises one of a slip luer, a threaded luer, or a luer lock with collar (Fig. 4, [0047] a luer connector may comprise external threads and engages with the disinfecting cap by a twisting action, and thus is a threaded luer).
Regarding Claim 4, Vandenbrink and Okman teach the system of claim 1, comprising an adapter including a first engagement feature and a second engagement feature, the first engagement feature of the adapter configured to releasably engage with the cap of the container assembly and the second engagement feature of the adapter configured to releasably engage with a housing engagement feature of the fluid access assembly such that, in a first configuration in which the first engagement feature of the adapter is engaged with the cap and the second engagement feature of the adapter is engaged with the engagement feature of the fluid access assembly, the cap of the container assembly is at least partially disposed within the interior of the housing and spaced from the fluid access component ([0039], [0048]-[0050], [0052], [0060], [0061] adaptor 230 with first engagement feature 231 and second engagement feature 232, housing engagement feature 222 show this relationship, the cap of the reservoir has a resealable membrane).
Regarding Claim 5, Vandenbrink and Okman teach the system of claim 4, wherein the container assembly is configured to be transitioned from the first configuration to a second configuration via translating the container assembly toward the first end of the fluid access assembly such that the cap is disengaged from the first engagement feature of the adapter and the fluid access component pierces a resealable membrane of the cap such that the reservoir of the container assembly is in fluidic communication with the fluid connector component and the connection portion via the lumen of the fluid access component (See Claim 4 Rejection).
Regarding Claim 10, Vandenbrink and Okman teach the system of claim 2, wherein the connector portion of the scrubbing cap secures the scrubbing cap via a twist-type engagement (Fig. 4, [0047] a luer connector may comprise external threads and engage with the disinfecting cap by a twisting action), and wherein the scrubbing cap is removable (Fig. 4, [0047] threaded connections are removable) to enable connection of the system to an access port of a vascular access device (See Claim 2 Rejection, removal of the scrubbing cap enables the connection of the system of Vandenbrink to other devices).
Regarding Claim 12, Vandenbrink and Okman teach the system of claim 1, and Okman teaches wherein the scrubbing cap comprises a seal attached over the cavity to seal the scrubbing insert within the cavity ([0052]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the scrubbing cap of Vandenbrink and Okman with a removable seal as taught by Okman to prevent the disinfectant or the antimicrobial agent from exiting the chamber of a container.
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink in view of Okman and further in view of Burkholz et al (US 2021/0213245) (“Burkholz”).
Regarding Claim 6, while Vandenbrink and Okman teach the system of claim 1, their combined efforts fail to teach the system comprising an extension member having a distal end and a proximal end, the proximal end of the extension member coupled to the fluid connector component, wherein the extension member is configured to reduce hemolysis of a blood sample passing therethrough, and wherein the scrubbing cap comprises a connector portion configured to engage with the distal end of the extension member to secure the scrubbing cap to the extension member.
However Burkholz teaches a vascular system (Abstract, [0005]) comprising a fluid access assembly (Fig. 1, [0047] luer-lock access device 130 / fluid access assembly) and an extension member having a distal end and a proximal end (Fig. 1, [0047] multi-lumen extension system 100 / extension member), the proximal end of the extension member coupled to a fluid connector component ([0047] proximal end of multi-lumen extension system 100 / extension member couples to a fluid connector component of a luer-lock access device 130, i.e. a luer lock), wherein the extension member is configured to reduce hemolysis of a blood sample passing therethrough ([0055]-[0059] geometric factor of extension member’s lumens designed to reduce hemolysis) where the distal end of the extension member is configured to secure the extension member to another device ([0048]-[0049])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the system of Vandenbrink with an extending member intermediate to a vascular access device and a fluid access assembly as taught by Burkholz to reduce blood hemolysis occurring during blood collection. This ensures the blood cells are not damaged during collection, which may require discarding of the blood sample. Furthermore, it would be obvious to place the scrubbing cap’s connector portion configured to engage with the distal end of the extension member as this ensures the location interfacing with a secondary medical connector (now the distal end of the extension member rather than the distal end of the blood sample collection system) is maintained sterile.
Regarding Claim 7, Vandenbrink, Okman, and Burkholz teach the system of claim 6, and Burkholz teaches wherein the extension member comprises:
a connector interface disposed at the distal end and configured to couple the extension member to a vascular access port (See Claim 6 Rejection, [0047]-[0048]); and
a flexible tube fluidly coupled to a connector interface and configured to be coupled to the fluid connector component of a fluid access assembly ([0123] extension tubing may also be constructed as flexible, coupling to a luer-lock access device at the proximal end 135 indicating a connection to a connector interface, [0047]-[0048] fluidly coupled at the connector interface), wherein the tube is configured to reduce hemolysis of a blood sample passing therethrough (See Claim 6 Rejection).
Regarding Claim 8, Vandenbrink, Okman, and Burkholz teach the system of claim 6, wherein the extension member comprises a compact connector, the compact connector comprising:
a proximal connector portion configured to couple the compact connector to the fluid connector component (See Claim 6 Rejection, proximal end portion coupling to luer-lock access device);
a distal connector portion configured to couple the compact connector to an access port of a vascular access device (See Claim 6 Rejection, [0047]-[0048] distal end portion coupling to an IV device); and
a central portion shaped and configured to reduce hemolysis of a blood sample passing therethrough (See Claim 6 Rejection, length of multi-lumen extension system 100, including the lumens constructed to reduce hemolysis).
Regarding Claim 9, Vandenbrink, Okman, and Burkholz teach the system of claim 7, wherein the connector interface or the distal connector 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 ([0052] connector interface of extension system is a male adapter for connection to an IV device, [0060] the connection being a luer port).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink in view of Okman as evidenced by Strowe (US 5,992,899).
Regarding Claim 11, Vandenbrink and Okman teach the system of claim 1, and Okman further teaches wherein the scrubbing insert comprises a resilient material ([0015], [0036] scrub element is a nonwoven material, foam, or a sponge, specifically a polyurethane foam, where polyurethan is known in the art as a resilient material as evidenced by Strowe: Col. 7, L. 14-22) including an antimicrobial solution or agent absorbed therein (Abstract, [0017], [0036] scrubbing element 110 may absorb antimicrobial agent) configured to disinfect a surface of the access port of the vascular access device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have scrubbing insert of Vandenbrink and Okman be a resilient material including an absorbed antimicrobial solution as taught by Okman as a standardized construction to achieve consistent disinfecting results across applications of the invention.
Claim(s) 13-15 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink in view of Howlett et al (US 2009/0062766) (“Howlett”).
Regarding Claim 13, while Vandenbrink teaches a method of using a blood sample collection system (Fig. 1, [0039]-[0040], Fig. 2B, [0052], [0054]), comprising:
providing the blood sample collection system (Fig. 1, [0039]-[0040], Fig. 2B, [0052]), the system comprising:
a container assembly comprising a cap and defining a reservoir, the container assembly having a distal end and a proximal end, the cap disposed at the distal end of the container assembly (Fig. 1, [0039]-[0040], Fig. 2B, [0052] container assembly 210 comprises a cap 212 and tube 214 defining a reservoir 211, the container assembly having a distal end and a proximal end 216, the cap 212 disposed at the distal end of the container assembly 210);
a fluid access assembly comprising a housing defining an interior, a fluid access component, and a fluid connector component (Fig. 1, [0039]-[0040], Fig. 2B, [0052] fluid access assembly 220 comprises a housing 228 defining an interior 221, a fluid access component 224, and a fluid connector component 226), the housing having a distal end and a proximal end, the fluid access component extending from the distal end of the housing into the interior of the housing ([0054] distal end 223, proximal end 225, fluid access component 224 reflect this relationship), the fluid access component defining a lumen, the fluid connector component disposed on the distal end of the housing ([0054] a fluid access component 224 defines a lumen by a needle, the fluid connector component 226 is disposed on the distal end of the housing 223);
and further teaches that the system can be configured for transport in a sterile manner ([0060]),
Vandenbrink fails to teach the system comprising a scrubbing cap provided at or adjacent a distal end of the fluid access assembly, the scrubbing cap comprising:
A scrubbing insert; and
a housing defining a cavity configured to retain the scrubbing insert therein.
positioning the scrubbing cap over an access port of a vascular access device, such that the access port contacts the scrubbing insert; and
cleaning the access port with the scrubbing insert.
However Howlett teaches a sterility protecting cap for fluid sample collection system (Abstract, Fig. 15, [0085]-[0086]) comprising
placing a scrubbing cap provided at or adjacent a distal end of the fluid access assembly ([0085] “In one embodiment of cap assembly 270, secondary cap portion 276 can be selectively disconnected from cap 274 either before or after use of syringe 278. Likewise, secondary cap portion 276 could be disconnected from pair of caps 272 so that pair of caps 272 and syringe 276 can be used independently from one another.” Scrubbing cap / nestable pair of caps 272 with the placement of the scrub assembly at the distal end of a syringe 278 noted as occurring prior to use of the syringe) the scrubbing cap comprising:
A scrubbing insert ([0071]-[0073] caps are described with a scrubbing insert / pad for scrubbing the opening edge of the medical connector); and
a housing defining a cavity configured to retain the scrubbing insert therein ([0071]-[0073] the shown outer portion of caps act as housing for an internal cavity with the scrubbing insert);
positioning the scrubbing cap over an access port of a vascular access device, such that the access port contacts the scrubbing insert ([0062] scrubbing caps / nestable pair of caps 272 described herein may be structured to interface with male and female luer connectors, common fluid access connectors, [0085] “In one embodiment of cap assembly 270, secondary cap portion 276 can be selectively disconnected from cap 274 either before or after use of syringe 278. Likewise, secondary cap portion 276 could be disconnected from pair of caps 272 so that pair of caps 272 and syringe 276 can be used independently from one another.” Scrubbing cap / nestable pair of caps 272 can be separated from distal end of the fluid access assembly for independent use [0086] where independent use comprises removing secondary cap portion, connecting the syringe to medical connectors for syringe actuation, then utilizing the pair of cap by positioning the scrubbing cap over an access port of both the medical connector and the syringe, [0013] such as a vascular access device, such that the access port contacts the scrubbing insert); and
cleaning the access port with the scrubbing insert ([0086]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the scrubbing cap of Howlett to the fluid access assembly of Vandenbrink as Howlett teaches that fluid connector component are susceptible to contamination ([0014-[0016], [0062]-[0063]), for example luer connectors. And Vandebrink distal end is a fluid connector, and specifically, a luer connector ([0055]). Thus Howlett is providing a remedy for this susceptibility by interfacing the susceptible luer connector with a device to maintain sterility, a goal of Vanderbrink ([0060]). Furthermore, it would be obvious to follow the positioning and cleaning steps of Howlett to positively perform the action of disinfecting for the system Vandenbrink.
Regarding Claim 14, Vandenbrink and Howlett teach the method of claim 13, wherein the fluid connector component comprises a luer connector configured to be coupled to an access port of a vascular access device ([0062]-[0064]), and wherein the scrubbing cap comprises a connector portion configured to engage with the luer connector to secure the scrubbing cap to the fluid access assembly (See Claim 13 Rejection, Howlett [0062]-[0064] has caps structured to engage with luer connectors for securing of the scrubbing cap).
Regarding Claim 15, Vandenbrink and Howlett teach the method of claim 14, and Howlett further teaches the application of the scrubbing caps can be performed prior to connection between medical connectors ([0081]) and applying the separated nestable caps on separated medical connectors after a fluid transfer step ([0086]), their combined efforts fail to teach the method specifically comprising:
detaching the scrubbing cap from the luer connector subsequent to cleaning of the access port; and
coupling the luer connector to the access port, to place the fluid access assembly in fluid connection with the vascular access device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the separate teachings of Howlett of applying paired scrubbing caps on paired medical connectors and applying scrubbing caps for cleaning prior to connection of medical connectors can both be applied to Howlett’s Fig. 15 to provide the desired sterilized sampling connection before fluid collection occurs. And in doing so, the method would be applied to the connection of a fluid access assembly and vascular access device and cause the detaching of the scrubbing cap from the luer connector to be applied subsequent to cleaning of the access port to enable the coupling of the luer connector to the access port. This connection will then be actuated and place the fluid access assembly in fluid connection with the vascular access device.
Regarding Claim 18, Vandenbrink and Howlett teach the method of claim 13, wherein the system comprises an adapter including a first engagement feature and a second engagement feature, the first engagement feature of the adapter configured to releasably engage with the cap of the container assembly and the second engagement feature of the adapter configured to releasably engage with a housing engagement feature of the fluid access assembly such that, in a first configuration in which the first engagement feature of the adapter is engaged with the cap and the second engagement feature of the adapter is engaged with the engagement feature of the fluid access assembly, the cap of the container assembly is at least partially disposed within the interior of the housing and spaced from the fluid access component ([0039], [0048]-[0050], [0052], [0060], [0061] adaptor 230 with first engagement feature 231 and second engagement feature 232, housing engagement feature 222 show this relationship).
Regarding Claim 19, Vandenbrink and Howlett teach the method of claim 18, comprising:
translating the container assembly toward the first end of the fluid access assembly and relative to the adapter such that the cap is disengaged from the first engagement feature of the adapter and the fluid access component pierces a resealable membrane of the cap such that the reservoir of the container assembly is in fluidic communication with the fluid connector component via the lumen of the fluid access component (See Claim 18 Rejection, [0048], [0050] the cap of the reservoir has a resealable membrane);
decoupling the second engagement feature of the adapter from the engagement feature of the fluid access assembly ([0050]); and
translating the container assembly away from the first end of the fluid access assembly and out of the interior of the fluid access assembly such that the container assembly and the adapter are separated from the fluid access assembly ([0050]-[0051] removal of container assembly for discarding indicates a translation of the container assembly out of the interior of the fluid access assembly has occurred).
Regarding Claim 20, Vandenbrink and Howlett teach the method of claim 13, wherein the scrubbing cap comprises a seal attached over the cavity to seal the scrubbing insert within the cavity, and wherein the method further comprises removing the seal from the scrubbing cap, to enable positioning of the scrubbing cap over the access port of the vascular access device and contacting of the scrubbing insert with the access port (See Claim 13 Rejection, nested caps of nestable pair of caps 272 act as a seal to one another, thus indicating a seal attached over the cavity to seal the scrubbing insert within the cavity).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandenbrink in view of Howlett and further in view of Burkholz.
Regarding Claim 16, while Vandenbrink and Howlett teach the method of claim 13, their combined efforts fail to teach wherein the system comprises an extension member having a distal end and a proximal end, the extension member configured to reduce hemolysis of a blood sample passing therethrough, and wherein the scrubbing cap comprises a connector portion engaged with the distal end of the extension member to secure the scrubbing cap to the extension member.
However Burkholz teaches a vascular system (Abstract, [0005]) comprising a fluid access assembly (Fig. 1, [0047] luer-lock access device 130 / fluid access assembly) and an extension member having a distal end and a proximal end (Fig. 1, [0047] multi-lumen extension system 100 / extension member), the proximal end of the extension member coupled to a fluid connector component ([0047] proximal end of multi-lumen extension system 100 / extension member couples to a fluid connector component of a luer-lock access device 130, i.e. a luer lock), wherein the extension member is configured to reduce hemolysis of a blood sample passing therethrough ([0055]-[0059] geometric factor of extension member’s lumens designed to reduce hemolysis) where the distal end of the extension member is configured to secure the extension member to another device ([0048]-[0049])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the system of Vandenbrink with an extending member intermediate to a vascular access device and a fluid access assembly as taught by Burkholz to reduce blood hemolysis occurring during blood collection. This ensures the blood cells are not damaged during collection, which may require discarding of the blood sample. Furthermore, it would be obvious to place the scrubbing cap’s connector portion configured to engage with the distal end of the extension member as this ensures the location interfacing with a secondary medical connector (now the distal end of the extension member rather than the distal end of the blood sample collection system) is maintained sterile.
Regarding Claim 17, Vandenbrink, Howlett, and Burkholz teach the method of claim 16, comprising:
detaching the scrubbing cap from the distal end of the extension member subsequent to cleaning of the access port; and
coupling the distal end of the extension member to the access port, to place the fluid access assembly in fluid connection with the vascular access device.
and Howlett further teaches the application of the scrubbing caps can be performed prior to connection between medical connectors ([0081]) and applying the separated nestable caps on separated medical connectors after a fluid transfer step ([0086]), their combined efforts fail to teach the method specifically comprising:
detaching the scrubbing cap from the distal end of the extension member subsequent to cleaning of the access port; and
coupling the distal end of the extension member to the access port, to place the fluid access assembly in fluid connection with the vascular access device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the separate teachings of Howlett of applying paired scrubbing caps on paired medical connectors and applying scrubbing caps for cleaning prior to connection of medical connectors can both be applied to Howlett’s Fig. 15 to provide the desired sterilized sampling connection before fluid collection occurs. And in doing so, the method would be applied to the connection of a fluid access assembly’s extension member and a vascular access device and cause the detaching of the scrubbing cap from the luer connector to be applied subsequent to cleaning of the access port to enable the coupling of the luer connector to the access port. This connection will then be actuated and place the extension member in fluid connection with the vascular access device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791