DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 2-35 are currently pending. Claims 2-22 remain withdrawn. Claims 23, 28, 30, and 31 have been amended. Claims 32-35 have been added.
Claim Objections
Claim 34 is objected to because of the following informalities: “the blood barrier” in line 2 of claim 34 should read as “the selectively permeable blood barrier”. Appropriate correction is required.
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 23-35 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rogers et al. ‘445 (US Pub No. 2018/0177445 – previously cited).
Regarding claim 23, Rogers et al. ‘445 teaches a device (Title), comprising:
a containment channel (Fig. 23C sequestration chamber 2320 and [0137]) in fluid communication with an inlet (Fig. 23C inlet port 2316 and [0137]) and an outlet (Fig. 24B one or more apertures 2424 and ([0141]);
a sampling channel (Fig. 24B blood sequestration chamber 2418 and [0141]) in fluid communication with the inlet and the outlet ([0142]; “In operation, the inner chamber housing 2419 is in the first position toward the inlet port 2412, such that the one or more apertures 2424 are closed, and the blood sequestration chamber 2418 is in a direct path from the patient needle. Upon venipuncture of a patient, and drawing of blood by way of a syringe or Vacutainer, or other blood collection device 2404, the initial aliquot of blood flows into the blood sequestration chamber 2418. As the initial aliquot of blood flows into the blood sequestration chamber, it displaces air therein and eventually the blood contacts the blood barrier 2420, forcing the inner chamber housing to the second position.”);
a selectively permeable blood barrier (Fig. 24B blood barrier 2420 and [0142]) disposed between the containment channel and the outlet (Fig. 24B one or more apertures 2424 and ([0141]), the selectively permeable blood barrier configured such that a suction force introduced at the outlet causes (i) a flow of gas from the containment channel through the selectively permeable blood barrier and (ii) a volume of blood to flow into the containment channel and toward the selectively permeable blood barrier ([0142]; “In operation, the inner chamber housing 2419 is in the first position toward the inlet port 2412, such that the one or more apertures 2424 are closed, and the blood sequestration chamber 2418 is in a direct path from the patient needle. Upon venipuncture of a patient, and drawing of blood by way of a syringe or Vacutainer, or other blood collection device 2404, the initial aliquot of blood flows into the blood sequestration chamber 2418. As the initial aliquot of blood flows into the blood sequestration chamber, it displaces air therein and eventually the blood contacts the blood barrier 2420, forcing the inner chamber housing to the second position.”); and
a movable seal disposed, in a first state, between the inlet and the sampling channel to prevent the volume of blood from flowing through the sampling channel to the outlet, the movable seal configured to transition from the first state to a second state in response to an increase in a portion of the suction force in the sampling channel, wherein the increase in the portion of the suction force is a result of the volume of blood in the containment channel ([0142]; “In operation, the inner chamber housing 2419 is in the first position toward the inlet port 2412, such that the one or more apertures 2424 are closed, and the blood sequestration chamber 2418 is in a direct path from the patient needle. Upon venipuncture of a patient, and drawing of blood by way of a syringe or Vacutainer, or other blood collection device 2404, the initial aliquot of blood flows into the blood sequestration chamber 2418. As the initial aliquot of blood flows into the blood sequestration chamber, it displaces air therein and eventually the blood contacts the blood barrier 2420…”).
Regarding claim 24, Rogers et al. ‘445 teaches a housing (Fig. 23C blood sequestration device 2300’ and [0137]) having the inlet (Fig. 23C inlet port 2316 and [0137]) and the outlet (Fig. 24B one or more apertures 2424 and ([0141]), the housing defining each of the containment channel (Fig. 23C sequestration chamber 2320 and [0137]) and the sampling channel ([0142]; “In operation, the inner chamber housing 2419 is in the first position toward the inlet port 2412, such that the one or more apertures 2424 are closed, and the blood sequestration chamber 2418 is in a direct path from the patient needle. Upon venipuncture of a patient, and drawing of blood by way of a syringe or Vacutainer, or other blood collection device 2404, the initial aliquot of blood flows into the blood sequestration chamber 2418. As the initial aliquot of blood flows into the blood sequestration chamber, it displaces air therein and eventually the blood contacts the blood barrier 2420, forcing the inner chamber housing to the second position.”).
Regarding claim 25, Rogers et al. ‘445 teaches a flow path between an end portion of the containment channel and the outlet, at least a portion of the flow path is configured to modulate the suction force introduced at the end portion of the containment channel ([0142]; “In operation, the inner chamber housing 2419 is in the first position toward the inlet port 2412, such that the one or more apertures 2424 are closed, and the blood sequestration chamber 2418 is in a direct path from the patient needle. Upon venipuncture of a patient, and drawing of blood by way of a syringe or Vacutainer, or other blood collection device 2404, the initial aliquot of blood flows into the blood sequestration chamber 2418. As the initial aliquot of blood flows into the blood sequestration chamber, it displaces air therein and eventually the blood contacts the blood barrier 2420, forcing the inner chamber housing to the second position.”).
Regarding claim 26, Rogers et al. ‘445 teaches the inlet configured to be fluidically coupled to a patient ([0137]; “an inlet port 2316 to connect with a patient needle”).
Regarding claim 27, Rogers et al. ‘445 teaches the outlet configured to be fluidically coupled to a sample bottle that is at least partially evacuated, wherein fluidically coupling the outlet to the sample bottle introduces the suction force at the outlet ([0058]; “Vacutainer”).
Regarding claim 28, Rogers et al. ‘445 teaches wherein the movable seal comprises an elastomeric material ([0145]; “elastomeric material”).
Regarding claim 29, Rogers et al. ‘445 teaches wherein a portion of the sampling channel is physically and fluidically disposed between the selectively permeable blood barrier and the outlet (see Fig. 24B).
Regarding claim 30, Rogers et al. ‘445 teaches wherein a portion of the movable seal, in the second state, defines a portion of a flow path through the sampling channel ([0142]; “In operation, the inner chamber housing 2419 is in the first position toward the inlet port 2412, such that the one or more apertures 2424 are closed, and the blood sequestration chamber 2418 is in a direct path from the patient needle. Upon venipuncture of a patient, and drawing of blood by way of a syringe or Vacutainer, or other blood collection device 2404, the initial aliquot of blood flows into the blood sequestration chamber 2418. As the initial aliquot of blood flows into the blood sequestration chamber, it displaces air therein and eventually the blood contacts the blood barrier 2420, forcing the inner chamber housing to the second position.”).
Regarding claim 31, Rogers et al. ‘445 teaches wherein the sampling channel, when the movable seal is in the second state, is configured such that the suction force along the flow path draws a subsequent volume of blood from the inlet, through the sampling channel, to the outlet while bypassing at least a portion of the volume of blood contained in the containment channel ([0142]; “In operation, the inner chamber housing 2419 is in the first position toward the inlet port 2412, such that the one or more apertures 2424 are closed, and the blood sequestration chamber 2418 is in a direct path from the patient needle. Upon venipuncture of a patient, and drawing of blood by way of a syringe or Vacutainer, or other blood collection device 2404, the initial aliquot of blood flows into the blood sequestration chamber 2418. As the initial aliquot of blood flows into the blood sequestration chamber, it displaces air therein and eventually the blood contacts the blood barrier 2420, forcing the inner chamber housing to the second position.”).
Regarding claim 32, Rogers et al. ‘445 teaches wherein the movable seal transitioning from the first state to the second state includes the movable seal being moved, in response to the icrease in the portion of the suction force, from a first position to a second position ([0142]; “Upon venipuncture of a patient, and drawing of blood by way of a syringe or Vacutainer, or other blood collection device 2404, the initial aliquot of blood flows into the blood sequestration chamber 2418. As the initial aliquot of blood flows into the blood sequestration chamber, it displaces air therein and eventually the blood contacts the blood barrier 2420…”).
Regarding claim 33, Rogers et al. ‘445 teaches a lock configured to engage the movable seal to at least temporarily maintain the movable seal in the second position ([0142]; “locking mechanism”).
Regarding claim 34, Rogers et al. ‘445 teaches wherein the movable seal is configured to move relative to the blood barrier ([0141]-[0142]; “The blood sequestration chamber 2418…[that includes an air permeable blood barrier 2420]…is movable from a first position to receive and sequester a first aliquot of blood, to a second position to expose one or more apertures 2424 at a proximal end of the inner chamber housing 2419 to allow blood to bypass and/or flow around the inner chamber housing 2419 and through a blood sample channel 2422.”).
Regarding claim 35, Rogers et al. ‘445 teaches wherein the housing has an inner surface that defines each of the containment channel and the sampling channel (Blood sequestration device 2300’ has an inner surface that defines the sequestration chamber 2320 and main collection channel 2322, as seen in Fig. 23C in by the tubing.), and
the movable seal in the first state forms a seal with a portion of the inner surface to prevent the volume of blood from flowing through the sampling channel ([0137]; “A valve 2324 closes off and opens the collection chamber 2322, and the device 2300’ can be used…”).
Response to Arguments
Applicant has indicated the amendments to claim 23 would aid in advancing prosecution as Rogers et al. ‘445 does not teach “each and every limitation set forth in the claim.” Examiner respectfully disagrees, as Applicant has failed to indicate which limitations Rogers et al. ‘445 does not teach. Regarding the moveable seal limitation in claim 23, Examiner respectfully disagrees as the one or more apertures 2424 of Rogers et al. ‘445 can be opened and closed, as mentioned in [0142], indicating that there is a seal that can be “moved,” or as interpreted by the Examiner, “opened and closed.” As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 102(a)(2) rejection has been maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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