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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/09/2026 has been entered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Botich et al (US 6,096,005) (“Botich”).
Regarding Claim 1, while Botich teaches a system (Abstract, Figs. 7-8, Col. 7, L. 51 – Col. 8, L. 65) comprising:
a container assembly including a cap and defining a reservoir (Figs. 7-8, Col. 8, L. 31-37, cap / resilient perforatable seal 390 and reservoir / fluid sampling receptacle 381), the container assembly having a first end and a second end, the cap disposed at the first end of the container assembly (Figs. 7-8, Col. 8, L. 31-37, cap / resilient perforatable seal 390 disposed at first end and reservoir / fluid sampling receptacle 381 closed dome bottom disposed at second end);
a fluid access assembly including a housing defining an interior, a fluid access component, a fluid connector component, and an engagement feature (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 12, a fluid access assembly includes housing with defined interior / barrel 322, a fluid access component / hollow plunger 324, fluid connector component / converging tapered surface 346, and engagement feature / outside surface of barrel 322 at the open end 322a), the housing having a first end and a second end (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 12, housing . barrel 322 has a first end / reduced-diameter end 322b and a second end / open end 322a), the fluid access component extending from the first end of the housing into the interior of the housing (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 12, fluid access component / hollow plunger 324 extends from the first end / reduced-diameter end 322b into the interior the housing with hollow linking needle 384), the fluid access component defining a lumen (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 12, lumen within hollow plunger 324 continuous through the hollow linking needle 384), the fluid connector component disposed on the first end of the housing and configured to be coupled to a patient access device such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the fluid connector component and the patient access device (Figs. 7-8, Col. 7, L. 51-58, fluid connector component / converging tapered surface 346 disposed on the first end / reduced-diameter end 322b of the housing / barrel and configured to be coupled to a patient access / hypodermic needle 325 and associated spring and coupling structure, Col. 8, L. 38-65, such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the fluid connector component and the patient access device by the drawing of fluid through hypodermic needle 325 and into receptacle 381); and
an adapter (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 3, adapter / washer 380), the adapter including a first engagement feature and a second engagement feature (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 3, adapter / washer 380 including a first engagement feature / internal surface of washer 380 that defines a throughhole and a second engagement feature / curved surface of washer 380 engaging with open end 322a), the first engagement feature of the adapter to releasably engage with the cap of the container assembly and the second engagement feature of the adapter configured to releasably engage with the engagement feature of the fluid access assembly (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 3 and L. 38-65, the first engagement feature is the internal surface of the washer defining a throughhole. The replaceable centering washer 380 being a centering washer indicates the internal surface provides a controlled engagement interaction between the container assembly and the washer to stabilize the container into the center position and the movement of the container assembly past the washer indicates that the fitting of the container assembly at the cap is releasable. The second engagement features is the fitting of the replaceable centering washer 380 over top of the open end 322a of the barrel. The replaceable centering washer being replaced by washers of different sizes corresponding to container assembly size indicates a releasable engagement with 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 apart from the fluid access component, such that the reservoir of the container assembly remains fluidically isolated (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 3 and L. 38-65, when the cap / perforatable seal 390 is within replaceable centering washer 380, i.e. engaged with the first engagement feature and the second engagement feature is engaged by the washer being fit over the open end of the barrel, the cap of the container assembly is at least partially disposed within the interior of the housing and spaced apart from the fluid access component, such that the reservoir of the container assembly remains fluidically isolated);
wherein the first engagement feature comprises an inner surface of the adapter that defines a through hole through the adapter (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 3),
with the inner surface engaged with the cap via a friction fit (Col. 11, L. 8-22, confirms that engagement where positioning is controlled and engagement is between a first cylinder contacting the inner surface of an outer cylinder is occurring by friction fit); and
wherein the container assembly is transitionable 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, so as to no longer be engaged therewith via the friction fit (Figs. 7-8, Col. 8, L. 38-65, withdrawing fluid requires the container assembly / receptacle 381 to connect to the fluid access component / hollow plunger 324 so the container assembly is transitionable 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 as shown in Fig. 7), 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 (Figs. 7, Col. 8, L. 38-65, withdrawing fluid requires the container assembly / receptacle 381 to connect to the fluid access component / hollow plunger 324 by the resilient perforatable plug 390 being pierced by the hollow plunger 324, where the plug would be understood as resealable if it is representing a vacutainer).
Regarding Claim 3, Botich teaches the system of claim 1, wherein the reservoir of the container assembly is evacuated (See Claim 1 Rejection, Col. 8, L. 29-37, receptacle 381 is evacuated).
Regarding Claim 5, Botich teaches the system of claim 1, wherein the container assembly is a first container assembly, and further comprising a second container assembly 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 (Figs. 7-8, Col. 8, L. 38-65, the receptacle 381 may be replaced if another sample of blood is required, where movement maintaining centering would be translational movement).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Botich in view of Ebara et al (US 5,360,012) (“Ebara”).
Regarding Claim 4, while Botich teaches the system of claim 1, Botich fails to teach wherein the engagement feature of the fluid access assembly includes a flange extending outward relative to central axis of the housing of the fluid access assembly.
However Ebara teaches a system (Abstract, Fig. 1-2) comprising:
a container assembly including a cap and defining a reservoir, the container assembly having a first end and a second end, the cap disposed at the first end of the container assembly (Figs. 1-3, Col. 4, L. 5-26, container assembly / evacuated tube 3 including a cap / plug 15 and defining a reservoir, the container assembly having a first end and a second end, the cap disposed at the first end of the container assembly as shown in Figs. 1-2);
a fluid access assembly including a housing defining an interior, a fluid access component, a fluid connector component, and an engagement feature (Figs. 1-3, Col. 4, L. 5-26, fluid access assembly / tube holder 1 including a housing defining an interior made up of cylindrical body 5 a conical end 6, and a flange 7, a fluid access component / interior end of sampling needle with elastic sheath 12, fluid connector component / needle body 11, and an engagement feature / flange 7), the housing having a first end and a second end (Figs. 1-2, Col. 4, L. 5-26, first end / conical end 6 second end / end with flange 7), the fluid access component extending from the first end of the housing into the interior of the housing (Figs. 1-2, Col. 4, L. 5-26, a fluid access component / interior end of sampling needle with elastic sheath 12 extends from the first end / conical end 6 into the inner volume of the housing), the fluid access component defining a lumen (Fig. 1, lumen made by sampling needle), the fluid connector component disposed on the first end of the housing and configured to be coupled to a patient access device such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the fluid connector component and the patient access device (Figs. 1-2, the sampling needle 2 of the device is configured to be coupled to a patient access device such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the fluid connector component and the patient access device by being a sampling needle); and
and an adapter (Figs. 1-3, Col. 4, L. 5-26 adapter 4 / adapter), the adapter including a first engagement feature and a second engagement feature (Figs. 1-3, Col. 4, L. 27 — Col. 5, L. 10, adapter 4 includes a first engagement feature / flexible extensions 23 and a second engagement feature / flange 22).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the engagement feature of the fluid access assembly of Botich with an outwardly extending flange as taught in Ebara as a simple substitution of one form maintaining an adapter’s position at an end of a barrel (Botich: adapter curving over the walls of the open end) for another (Ebara: adapter flanges stopping flush with barrel flanges extending from the walls of the open end) to obtain predictable results of securely attached adapters.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Botich in view of Bullington et al (US 2015/0246352) (“Bullington”) as noted in Applicant IDS dated 12/21/2023.
Regarding Claim 6, while Botich teaches the system of claim 5, Botich fails to teach wherein the reservoir of the second container assembly includes a medium configured to be combined with a blood sample to perform a blood culture.
However Bullington teaches a system (Abstract, Figs. 9-12), comprising:
a container assembly including a cap and defining a reservoir, the container assembly having a first end and a second end, the cap disposed at the first end of the container assembly (Figs. 9-12, [0093]-[0094], [0106] fluid reservoir 310 / container assembly including a port 313 / cap and defining a reservoir, having a distal end portion 311 / first end and a second end, the port 313 / cap disposed at the distal end portion 311 / first end of the container assembly);
a fluid access assembly including a housing defining an interior, a fluid access component, a fluid connector component, and an engagement feature (Figs. 9-12, [0093]-[0096], [0102] transfer adapter 320 / fluid access assembly including a housing defining an inner volume 336 / interior, puncture member 350 / a fluid access component, port 324 / a fluid connector component, and an inner portion of the annular walls 325 / an engagement feature), the housing having a first end and a second end (Figs. 9-12, [0093]-[0096], distal end portion 323 / first end and proximal end portion 321 / a second end), the fluid access component extending from the first end of the housing into the interior of the housing (Figs. 9-12, puncture member 350 / a fluid access component extends from the distal end portion 323 / first end of the housing into the inner volume 336 / interior of the housing), the fluid access component defining a lumen ([0102]), the fluid connector component disposed on the first end of the housing and configured to be coupled to a patient access device such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the fluid connector component and the patient access device (Figs. 9-12, [0102] port 324 / fluid connector component disposed on the distal end portion 323 / first end of the housing and configured to be coupled to a patient access device, such as “a catheter, cannula, needle, trocar, or the like”, such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the port 324 / fluid connector component and the patient access device); and
an adapter including a first engagement feature and a second engagement feature (Figs. 9-12, [0098] release member 330 / adapter includes release member 330’s tabs 330 / first engagement features and a second engagement feature / release member 330’s attachment to the transfer adaptor 320 / fluid access assembly), the first engagement feature of the adapter configured to releasably engage with the shoulder of the container assembly ([0098] tabs 333 selectively limit movement of fluid reservoir, shown in Fig. 11 to maintain spacing between the fluid reservoir and the fluid access component), and the second engagement feature of the adapter configured to be continuous with the engagement feature of the fluid access assembly ([0098] release members 330 / adapter configured to be formed with the inner surface of the annular walls 325 / engagement feature of the fluid access assembly).
wherein the reservoirs of container assemblies include a medium configured to be combined with a blood sample to perform a blood culture ([0084] the utilized container assemblies may include culture bottles configured to be combined with a blood sample to perform a blood culture).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply blood culture bottles of Bullington as the fluid container assemblies in Botich as a way for the secure collection of a blood sample to enable streamlining of the process of testing blood for the presence of particular organisms ([0084]).
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Botich in view of Lee (US 2014/0207082).
Regarding Claim 25, while Botich teaches the system of claim 1, their combined efforts fail to teach wherein the engagement feature of the fluid access assembly comprises a flange, and wherein the second engagement feature of the adapter comprises a pair of oppositely disposed tabs, with each of the tabs including a latch configured to receive a portion of the flange to releasably engage the second engagement feature with the engagement feature.
However Lee teaches a syringe (Abstract) comprising a fluid access component with a flange as an engagement feature (Fig. 1, [0053]-[0055] cylinder 120 / fluid access component with a cylinder flange 122 as an engagement feature), where the fluid access component connects to an interfacing component (Fig. 1, [0053]-[0055] cylinder 120 / fluid access component connects to interfacing component / auxiliary device 200) where the second engagement feature of the interfacing component comprises a pair of oppositely disposed tabs, with each of the tabs including a latch configured to receive a portion of the flange to releasably engage the second engagement feature with the engagement feature ([0053]-[0057] fixing clips 215 includes oppositely disposed tabs with latches / fixing jaws 216 to receive a portion of the flange of a syringe).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the curved engagement feature of the fluid access assembly of Botich with a syringe flange and interfacing component utilizing rotation fixation with the syringe flange to achieve connection between the two syringe components as taught by Lee as a simple substitution of one form maintaining an adapter’s position at an end of a barrel (Botich: adapter curving over the walls of the open end) for another (Lee: a rotating engagement mechanism over a flange) to obtain predictable results of securely attached adapters.
Regarding Claim 26, Botich and Lee teach the system of claim 25, wherein the adapter is rotatable relative to the fluid access assembly, to rotate the latches out of engagement with the flange, thereby enabling disengagement of the adapter from the fluid access assembly (See Claim 25 Rejection).
Claim(s) 8-9, 11, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Botich in view of Porcher et al (US 4,976,925) (“Porcher”).
Regarding Claim 8, while Botich teaches a method of using a system (Abstract, Figs. 7-8, Col. 7, L. 51 – Col. 8, L. 65), the system in an initial configuration including:
a container assembly including a cap and defining a reservoir (Figs. 7-8, Col. 8, L. 31-37, cap / resilient perforatable seal 390 and reservoir / fluid sampling receptacle 381), the container assembly having a first end and a second end, the cap disposed at the first end of the container assembly (Figs. 7-8, Col. 8, L. 31-37, cap / resilient perforatable seal 390 disposed at first end and reservoir / fluid sampling receptacle 381 closed dome bottom disposed at second end);
a fluid access assembly including a housing defining an interior, a fluid access component, a fluid connector component, and an engagement feature (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 12, a fluid access assembly includes housing with defined interior / barrel 322, a fluid access component / hollow plunger 324, fluid connector component / converging tapered surface 346, and engagement feature / outside surface of barrel 322 at the open end 322a), the housing having a first end and a second end (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 12, housing . barrel 322 has a first end / reduced-diameter end 322b and a second end / open end 322a), at least a portion of the fluid access component extending from the first end of the housing into the interior of the housing (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 12, fluid access component / hollow plunger 324 extends from the first end / reduced-diameter end 322b into the interior the housing with hollow linking needle 384), the fluid access component defining a lumen (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 12, lumen within hollow plunger 324 continuous through the hollow linking needle 384), the fluid connector component disposed on the first end of the housing and configured to be coupled to a patient access device such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the fluid connector component and the patient access device (Figs. 7-8, Col. 7, L. 51-58, fluid connector component / converging tapered surface 346 disposed on the first end / reduced-diameter end 322b of the housing / barrel and configured to be coupled to a patient access / hypodermic needle 325 and associated spring and coupling structure, Col. 8, L. 38-65, such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the fluid connector component and the patient access device by the drawing of fluid through hypodermic needle 325 and into receptacle 381), the engagement feature of the fluid access assembly disposed on the second end of the housing (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 12, engagement feature / outside surface of barrel 322 at the open end 322a); and
an adapter including a first engagement feature and a second engagement feature (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 3, adapter / replaceable centering washer 380 including a first engagement feature / internal surface of washer 380 that defines a throughhole and a second engagement feature / curved surface of washer 380 engaging with open end 322a), the first engagement feature of the adapter to releasably engage with the cap of the container assembly and the second engagement feature of the adapter configured to releasably engage with the engagement feature of the fluid access assembly (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 3 and L. 38-65, the first engagement feature is the internal surface of the washer defining a throughhole. The replaceable centering washer 380 being a centering washer indicates the internal surface provides a controlled engagement interaction between the container assembly and the washer to stabilize the container into the center position and the movement of the container assembly past the washer indicates that the fitting of the container assembly at the cap is releasable. The second engagement features is the fitting of the replaceable centering washer 380 over top of the open end 322a of the barrel. The replaceable centering washer being replaced by washers of different sizes corresponding to container assembly size indicates a releasable engagement with the fluid access assembly) in the initial configuration such that the cap of the container assembly is at least partially disposed within the interior of the housing and spaced apart from the fluid access component, such that the reservoir of the container assembly remains fluidically isolated (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 3 and L. 38-65, when the cap / perforatable seal 390 is within replaceable centering washer 380, i.e. engaged with the first engagement feature and the second engagement feature is engaged by the washer being fit over the open end of the barrel, the cap of the container assembly is at least partially disposed within the interior of the housing and spaced apart from the fluid access component, such that the reservoir of the container assembly remains fluidically isolated);
wherein the first engagement feature comprises an inner surface of the adapter that defines a through hole through the adapter (Figs. 7-8, Col. 7, L. 59 – Col. 8, L. 3), with the inner surface engaged with the cap via a friction fit (Col. 11, L. 8-22, confirms that engagement where positioning is controlled and engagement is between a first cylinder contacting the inner surface of an outer cylinder is occurring by friction fit); and
wherein the method comprises
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, so as to no longer be engaged therewith via the friction fit, and the fluid access component pierces a 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 (Figs. 7-8, Col. 8, L. 38-65, the receptacle 381 is urged forward / translated toward the first end of the fluid access assembly, where an end state is shown in Fig. 7 with the cap disengaged from the first engagement feature of the adapter, so as to no longer be engaged therewith via the friction fit, and the fluid access component / hollow plunger 324 pierces a 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 for the drawing of the fluid into the receptacle),
with translation of the container assembly being responsive to application of a pushing force to the container assembly that overcomes a force of the friction fit between the cap and the inner surface of the adapter (Figs. 7-8, Col. 8, L. 38-65, urging forward motion enables the receptacle 381 to reach the hollow plunger 324 in a centered manner by washer 380, indicating a pushing force to the container assembly that overcomes a force of the friction fit between the cap and the inner surface of the adapter while the container assembly as a whole is maintained centered);
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 is separated from the fluid access assembly (Figs. 7-8, Col. 8, L. 38-65, removal of receptacle 381 is noted with no note of change in washer and Fig. 8 shows washer maintained at open end. Thus a translation happens in a centered manner through the washer when separating from the fluid access assembly), Botich fails to teach
decoupling the second engagement feature of the adapter from the engagement feature of the fluid access assembly; 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.
However Porcher teaches a method of using a system (Abstract, Figs. 1-3 and 5), the system in an initial configuration including:
a container assembly including a cap and defining a reservoir, the container assembly having a first end and a second end, the cap disposed at the first end of the container assembly (Figs. 1-3 and 5, Col. 43-55, collecting tube 38 / container assembly including a cap 44 / cap and defining a reservoir, having an end 42 / first end and an end 40 / second end, the cap 44 / cap disposed at the end 42 first end of the container assembly);
a fluid access assembly including a housing defining an interior, a fluid access component, a fluid connector component, and an engagement feature (Fig. 1-3 and 5, Col. 3, L. 8-25, head 12 / fluid access assembly including a housing defining an interior, pin 26 / a fluid access component, needle mounting 22 / a fluid connector component, and moulded joining unit / an engagement feature), the housing having a first end and a second end (Figs. 1-3, 5, Col. 3, L. 10-25, first end where base 16 and envelope 18 are found, second end where the head 12 / fluid access assembly meets with body 14), the fluid access component extending from the first end of the housing into the interior of the housing (Figs. 1-3, 5, Col. 3, L. 10-25), the fluid access component defining a lumen (Figs. 1-3, 5, central canal 28 / lumen), the fluid connector component disposed on the first end of the housing and configured to be coupled to a patient access device such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the fluid connector component and the patient access device (Figs. 1-3, 5, Col. 3, L. 16-21, needle mount 22 / fluid connector component can be coupled to a patient access device such as a needle to provide fluid communication with a patient's vasculature via the fluid connector component and the patient access device), the engagement feature of the fluid access assembly disposed on the second end of the housing (Figs. 1-3, and 5); and
an adapter including a first engagement feature and a second engagement feature (Figs. 1-3, 5, Col. 2, L. 25-37, Col. 4, L. 15-19 body 14 / adapter includes a second engagement features of an end connected to the moulded joining unit/detachable joining ring and a first engagement feature of outer collar 32 and retaining studs 36), the first engagement feature of the adapter releasably engaged with the cap of the container assembly (Figs. 1-3, 5, Col. 3, L. 26-39, cap 44 / cap releasably engages with the retaining studs 36 / first engagement feature to enable translation of cap to fluid access component), and the second engagement feature of the adapter releasably engaged with the engagement feature of the fluid access assembly in the initial configuration (Figs. 1-3, 5, Col. 3, L. 46 – 57, after sampling, the portion of the body 14 connected to the moulded joining unit/detachable joining ring / second engagement feature may releasably engage with the engagement feature of the fluid access assembly / moulded joining unit by breaking away or detachment of the detachable joining ring) such that the cap of the container assembly is at least partially disposed within the interior of the housing and spaced from the fluid access component (Figs. 1, Col. 2, L. 43 – Col. 3, L. 15, while the cap of the cap of the container assembly is shown very closely with the fluid access component, they are considered as spaced apart as contact, i.e. piercing, does not occur until translation of the container assembly described as occurring in Fig. 2), the method 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 (Figs. 2-3, Col. 3, L. 8-49);
decoupling the second engagement feature of the adapter from the engagement feature of the fluid access assembly (Fig. 5, Col. 3, L. 46-57, end of body 14 attached to head 12 decouples from the moulded joining unit/detachable joining ring); 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 (Fig. 5, Col. 3, L. 46-57, collecting tube 38 translates away from the first end of head 12 and out of the interior such that the collecting tube and the body 14 are separated from the head 12).
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 steps of adapter configuration of Porcher to Botich as a step that can simplify the process of replacing the replaceable washer of the barrel of Botich – by making the removal of the washer automatic.
Regarding Claim 9, Botich and Porcher teach the method of claim 8, and Porcher further teaches where the method comprises sterilizing the system (Col. 3, L. 3-8).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the system of Botich and Porcher with a sterilization step as taught by Porcher to reduce the risk of transmitting infections.
Regarding Claim 11, Botich and Porcher teach the method of claim 8, wherein the container assembly is a first container assembly, 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, 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 (See Claim 8 Rejection, Figs. 7-8, Col. 8, L. 38-65, the receptacle 381 may be replaced if another sample of blood is required, where movement maintaining centering would be translational movement, done in conjunction with the method rendered obvious in the rejection of Claim 8).
Regarding Claim 13, Botich and Porcher teach the method of claim 8, and Botich teaches wherein translating a container assembly toward the first end of the fluid access assembly and relative to the adapter such that the fluid access component pierces a resealable membrane of the cap causes the reservoir to draw fluid from a fluid source fluidically coupled to the fluid connector component, through the fluid access component, and into the reservoir of the container assembly due to the reservoir of the container assembly being evacuated (See Claim 8 Rejection, Col. 8, L. 29-37, by nature of the reservoir 381 being evacuated).
Regarding Claim 14, Botich and Porcher teach the method of claim 13, and Botich teaches wherein the fluid source is a vasculature system of a patient (See Claim 13 Rejection).
Claim(s) 10 and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Botich in view of Porcher and further in view of Lee (US 2014/0207082).
Regarding Claim 10, while Botich and Porcher teach the method of claim 8, their combined efforts fail to teach wherein decoupling the second engagement feature of the adapter from the engagement feature of the fluid access assembly includes at least one of rotating, unlatching, and/or deforming the adapter relative to the housing of the fluid access assembly.
However Lee teaches a syringe (Abstract) where a fluid access component connects to an interfacing component (Fig. 1, [0053]-[0055] cylinder 120 / fluid access component connects to interfacing component / auxiliary device 200) where the second engagement feature of the interfacing component comprises a pair of oppositely disposed tabs, with each of the tabs including a latch configured to receive a portion of the flange to releasably engage the second engagement feature with the engagement feature ([0053]-[0057] fixing clips 215 includes oppositely disposed tabs with latches / fixing jaws 216 to receive a portion of the flange of a syringe).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the curved engagement feature of the fluid access assembly of Botich with a syringe flange and interfacing component utilizing rotation fixation with the syringe flange to achieve connection between the two syringe components as taught by Lee as a simple substitution of one form maintaining an adapter’s position at an end of a barrel (Botich: adapter curving over the walls of the open end) for another (Lee: a rotating engagement mechanism over a flange) to obtain predictable results of securely attached adapters.
Regarding Claim 23, while Botich and Porcher teach the method of claim 8, their combined efforts fail to teach wherein the engagement feature of the fluid access assembly comprises a flange, and wherein the second engagement feature of the adapter comprises a pair of oppositely disposed tabs, with each of the tabs including a latch configured to receive a portion of the flange to releasably engage the second engagement feature with the engagement feature.
However Lee teaches a syringe (Abstract) comprising a fluid access component with a flange as an engagement feature (Fig. 1, [0053]-[0055] cylinder 120 / fluid access component with a cylinder flange 122 as an engagement feature), where the fluid access component connects to an interfacing component (Fig. 1, [0053]-[0055] cylinder 120 / fluid access component connects to interfacing component / auxiliary device 200) where the second engagement feature of the interfacing component comprises a pair of oppositely disposed tabs, with each of the tabs including a latch configured to receive a portion of the flange to releasably engage the second engagement feature with the engagement feature ([0053]-[0057] fixing clips 215 includes oppositely disposed tabs with latches / fixing jaws 216 to receive a portion of the flange of a syringe).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the curved engagement feature of the fluid access assembly of Botich with a syringe flange and interfacing component utilizing rotation fixation with the syringe flange to achieve connection between the two syringe components as taught by Lee as a simple substitution of one form maintaining an adapter’s position at an end of a barrel (Botich: adapter curving over the walls of the open end) for another (Lee: a rotating engagement mechanism over a flange) to obtain predictable results of securely attached adapters.
Regarding Claim 24, Botich, Porcher, and Lee teach the method of claim 23, wherein the adapter is rotatable relative to the fluid access assembly, to rotate the latches out of engagement with the flange, thereby enabling disengagement of the adapter from the fluid access assembly (See Claim 23 Rejection).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Botich in view of Porcher and further in view of Bullington.
Regarding Claim 12, while Botich and Porcher teaches the method of claim 11, Botich fails to teach wherein the reservoir of the second container assembly includes a medium configured to be combined with a blood sample to perform a blood culture.
However Bullington teaches a system (Abstract, Figs. 9-12), comprising:
a container assembly including a cap and defining a reservoir, the container assembly having a first end and a second end, the cap disposed at the first end of the container assembly (Figs. 9-12, [0093]-[0094], [0106] fluid reservoir 310 / container assembly including a port 313 / cap and defining a reservoir, having a distal end portion 311 / first end and a second end, the port 313 / cap disposed at the distal end portion 311 / first end of the container assembly);
a fluid access assembly including a housing defining an interior, a fluid access component, a fluid connector component, and an engagement feature (Figs. 9-12, [0093]-[0096], [0102] transfer adapter 320 / fluid access assembly including a housing defining an inner volume 336 / interior, puncture member 350 / a fluid access component, port 324 / a fluid connector component, and an inner portion of the annular walls 325 / an engagement feature), the housing having a first end and a second end (Figs. 9-12, [0093]-[0096], distal end portion 323 / first end and proximal end portion 321 / a second end), the fluid access component extending from the first end of the housing into the interior of the housing (Figs. 9-12, puncture member 350 / a fluid access component extends from the distal end portion 323 / first end of the housing into the inner volume 336 / interior of the housing), the fluid access component defining a lumen ([0102]), the fluid connector component disposed on the first end of the housing and configured to be coupled to a patient access device such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the fluid connector component and the patient access device (Figs. 9-12, [0102] port 324 / fluid connector component disposed on the distal end portion 323 / first end of the housing and configured to be coupled to a patient access device, such as “a catheter, cannula, needle, trocar, or the like”, such that the lumen of the fluid access component can be in fluidic communication with a patient's vasculature via the port 324 / fluid connector component and the patient access device); and
an adapter including a first engagement feature and a second engagement feature (Figs. 9-12, [0098] release member 330 / adapter includes release member 330’s tabs 330 / first engagement features and a second engagement feature / release member 330’s attachment to the transfer adaptor 320 / fluid access assembly), the first engagement feature of the adapter configured to releasably engage with the shoulder of the container assembly ([0098] tabs 333 selectively limit movement of fluid reservoir, shown in Fig. 11 to maintain spacing between the fluid reservoir and the fluid access component), and the second engagement feature of the adapter configured to be continuous with the engagement feature of the fluid access assembly ([0098] release members 330 / adapter configured to be formed with the inner surface of the annular walls 325 / engagement feature of the fluid access assembly).
wherein the reservoirs of container assemblies include a medium configured to be combined with a blood sample to perform a blood culture ([0084] the utilized container assemblies may include culture bottles configured to be combined with a blood sample to perform a blood culture).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply blood culture bottles of Bullington as the fluid container assemblies in Botich as a way for the secure collection of a blood sample to enable streamlining of the process of testing blood for the presence of particular organisms ([0084]).
Response to Arguments
Applicant’s amendments and arguments filed 3/09/2026 with respect to the 35 USC 103 rejections have been fully considered and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of
Botich for Claim 1, and
Botich and Porcher for Claim 8.
The rejection stands.
Consequently, claims 3-6, 9-14, and 23-26 remain rejected due to their dependency on rejected independent claims 1 and 8.
Conclusion
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights