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 Claims 2-21 remain withdrawn. Claims 22 and 29-31 have been amended. Claims 32-35 have been added.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 29-31 recite the limitation “the moveable seal flow controller.” There is insufficient antecedent basis for this limitation in the claim. “Flow controller” in claim 22 was amended to read as “moveable seal.” It is unclear if “the moveable seal flow controller” in claims 29-31 are referring to “moveable seal.” Clarification is requested.
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 22-35 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 22, Rogers et al. ‘445 teaches a device (Title), comprising:
a housing (Fig. 23C blood sequestration device 2300’ and [0137]) having an inlet (Fig. 23C inlet port 2316 and [0137]) and an outlet (Fig. 23C outlet port 2318 and [0137]), the housing defining each of a containment channel (Fig. 23C sequestration chamber 2320 and [0137]) and a sampling chamber (Fig. 23C main collection channel 2322 and [0137]);
a selectively permeable blood barrier (Fig. 24B blood barrier 2420 and [0142]) disposed in the housing and in fluidic communication with the containment channel and the outlet (Fig. 24B one or more apertures 2424 and ([0141]), the selectively permeable blood barrier and the containment channel defining at least a portion of a flow path such that a suction force introduced at the outlet draws (i) a gas from the containment channel, through the selectively permeable blood barrier, to 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…”) and (ii) a volume of blood from the inlet into the containment channel ([0141]-[0143]; “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 moveable seal disposed in the housing, the moveable seal configured, in a first state, to substantially obstruct fluid flow into at least a portion of the sampling channel, the moveable 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, forcing the inner chamber housing to the second position.”).
Regarding claim 23, Rogers et al. ‘445 teaches wherein the inlet is configured to be fluidically coupled to a patient ([0137]; “inlet port 2316 to connect with a patient needle”).
Regarding claim 24, Rogers et al. ‘445 teaches wherein the outlet is configured to be fluidically coupled to a fluid collection device ([0137]; “outlet port 2318 to connect with a blood sample collection device”).
Regarding claim 25, Rogers et al. ‘445 teaches wherein fluidically coupling the outlet to the fluid collection device introduces the suction force at the outlet ([0137]; “…an outlet port 2318 to connect with a blood sample collection device, such as a Vacutainer, a syringe, or the like.” Both a Vacutainer and syringe have a suction force.).
Regarding claim 26, Rogers et al. ‘445 teaches wherein the portion of the sampling channel is a first portion of the sampling channel (Fig. 24B inner chamber housing 2419), a second portion of the sampling channel is physically and fluidically disposed between the containment channel (Fig. 24B one or more apertures 2424) and the outlet (Fig. 24A shows that inner housing chamber 2419 is physically and fluidically connected to the outlet 2318.).
Regarding claim 27, Rogers et al. ‘445 teaches wherein the portion of the flow path is a first portion of the flow path, the second portion of the sampling channel forming a second portion of the flow path ([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 28, Rogers et al. ‘445 teaches wherein the selectively permeable blood barrier (blood barrier 2420) defines a portion of the containment channel (sequestration chamber 2320).
Regarding claim 29, Rogers et al. ‘445 teaches wherein the moveable seal flow controller comprises at least one of a plunger, as seal, a moveable plug, or an elastomeric material (Fig. 25C seal 2508 and [0145]).
Regarding claim 30, Rogers et al. ‘445 teaches wherein the portion of the suction force in the sampling channel moves at least a portion of the moveable seal flow controller from a first position to a second position, thereby transitioning moveable seal flow controller from the first state to the second state ([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 moveable seal flow controller is configured, in the second state, such that the sampling channel defines a portion of a flow path between the inlet and the outlet that receives a subsequent volume of blood ([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 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 33, Rogers et al. ‘445 teaches wherein the movable seal is configured to move relative to the selectively permeable 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 34, 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.).
Regarding claim 35, Rogers et al. ‘445 teaches wherein 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 22 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, 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791