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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03 October 2025 has been entered.
Response to Amendment
Claims 1-10 are currently pending. Claims 1-3 and 5-7 have been amended. Claims 9 and 10 have been added. The amendments to claim 1 have rendered the specification objection and 35 U.S.C. 112(a) rejection moot.
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.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers et al. ‘445 (US Pub No. 2018/0177445 – previously cited).
Regarding claim 1, Rogers et al. ‘445 teaches a device (Title, Abstract), comprising:
a housing (Fig. 23A blood sequestration device 2300 and [0137]) having an inlet configured to be fluidically coupled to a bodily-fluid source (Fig. 23A inlet port 2302 and [0135]) and an outlet (Fig. 23A outlet port 2304 and [0135]) configured to be fluidically coupled to a fluid collection device ([0135]; “…toward the outlet port 2304 and to the collection device.”), the housing defining a containment channel (Fig. 23C sequestration chamber 2320 and [0137]) and a sampling channel (Fig. 23C main collection channel 2322 and [0137]), both of which being fluidically disposed between the inlet and the outlet (Fig. 23C shows sequestration chamber 2320 and main collection channel 2322 are between the inlet port 2302 and outlet port 2304.);
a movable seal configured, in a first state, to substantially obstruct fluid flow into at least a portion of the sampling channel ([0142], Fig. 25C seal 2508 and [0145]); and
a selectively permeable blood barrier defining a portion of the containment channel, the selectively permeable blood barrier being fluidically coupled between the containment channel and the outlet (Fig. 23D, 23E air-permeable, blood impermeable barrier 2324 and [0137]),
the selectively permeable blood barrier and the containment channel are configured to define at least a portion of a flow path between the inlet and the outlet through which a gas flows in response to a suction force introduced at the outlet ([0135], [0142]), and
the selectively permeable blood barrier further configured to facilitate, based on a volume of the blood in the containment channel, an amount of the suction force building in the sampling channel to transition the movable seal from the first state to a second state ([0135], [0141]-[0143]).
Regarding claim 2, Rogers et al. ‘445 teaches wherein the movable seal is made from an elastomeric material (Fig. 25C seal 2508 and [0145]).
Regarding claim 3, Rogers et al. ‘445 teaches wherein the movable seal forms a fluid tight seal with at least one inner surface of the housing ([0138]; “…valve 2308 can also be formed as a flap, door or closable window or barrier within the sampling channel 2308.”).
Regarding claim 4, Rogers et al. ‘445 teaches wherein the gas flowing from the containment channel and through the selectively permeable blood barrier ceases when the volume of blood is in the containment channel ([0143]).
Regarding claim 5, Rogers et al. ‘445 teaches wherein transitioning the movable seal from the first state to the second state includes moving the movable seal from a first position to a second position ([0141]-[0142]).
Regarding claim 6, Rogers et al. ‘445 teaches wherein the movable seal is configured to transition from the first state to the second state automatically ([0141]-[0143]).
Regarding claim 7, Rogers et al. ‘445 teaches wherein the movable seal, in the second state, is configured such that the sampling channel facilitates a flow of a subsequent volume of blood from the bodily-fluid source to the outlet ([0141]-[0143]).
Regarding claim 8, Rogers et al. ‘445 teaches wherein the housing is configured such that the containment channel contains the volume of blood to limit contamination of the subsequent volume of blood that f lows through the sampling channel, which reduces false results in culture testing of the subsequent volume of blood ([0141]-[0143]).
Regarding claim 9, Rogers et al. ‘445 teaches a lock configured to engage the movable seal to at leas temporarily maintain the movable seal in the second position ([0142]; “…a locking mechanism of one or more small tabs, grooves, detents, bumps, ridges, or the like, to maintain the inner chamber housing 2419 in the first position until the blood sequestration chamber 2418 is filled, providing force to overcome the locking mechanism to enable movement of the inner chamber housing 2419 to the second position.”).
Regarding claim 10, Rogers et al. ‘445 teaches wherein the movable seal is configured to move relative to the selectively permeable blood barrier ([0145]).
Response to Arguments
Applicant’s filing of the terminal disclaimers over the ‘709 patient, ‘710 patent, and ‘863 patent have aided in overcoming the double patenting rejection. As such, the double patenting rejection has been withdrawn.
Applicant’s arguments regarding the 35 U.S.C. 102(a)(1) rejections have been fully considered however are not persuasive. Applicant argues that Rogers et al. ‘445 fails to teach “each and every limitation set forth in the claim.” However, Applicant does not explain why Rogers et al. ‘445 fails to teach each limitation. As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 102(a)(1) rejection has been maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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