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 1-10 are currently pending. Claim 1 has been amended.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2-10 are further rejected due to their dependency to claim 1.
Claim 1 recites “the housing forming a flow restrictor between the containment channel and the outlet.” The disclosure does not have support for the term “flow restrictor.” However, [0053] of the PGPUB recites “restrictor.” It is unclear if “flow restrictor” is referring to the “restrictor” in [0053] of the PGPUB. Clarification is requested.
Claim 1 recites “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 flow restrictor” in lines 9-11. However, [0072] of the PGPUB recites that the flow controller may be a restrictor or the selectively permeable member. The disclosure does not provide support for a flow restrictor and a selectively permeable blood barrier. Rather, the disclosure provides support for a flow controller being a restrictor or a selectively permeable blood barrier. For examination purposes, “flow restrictor” and “selectively permeable blood barrier” are used interchangeably in the claim since the flow controller could be either the restrictor or the selectively permeable blood barrier.
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.
Claim 1 is 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 2-10 are further rejected due to their dependency to claim 1.
Claim 1 recites “…the selectively permeable blood barrier being fluidically coupled between the containment channel and the flow restrictor…” in lines 9-11. As previously mentioned in the 35 U.S.C. 112(a) rejection, “flow restrictor” and “selectively permeable blood barrier” are used interchangeably. Because of this interpretation, it is unclear how the selectively permeable blood barrier could be between the containment channel and the flow restrictor. 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 1-10 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, to best to the Examiner’s understanding, 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.), the housing forming a flow restrictor between the containment channel and the outlet (Fig. 23D, 23E air-permeable, blood impermeable barrier 2324 and [0137]; As mentioned in the 35 U.S.C. 112(a) rejection, “flow restrictor” and “selectively permeable blood barrier” are used interchangeably.);
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 flow restrictor (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]), the flow restrictor operable to modulate the suction force exerted through the containment channel as a volume of blood is drawn into the containment channel ([0138]; “…the blood sample collection device 2404 includes a protective shield that includes a sealed collection needle on which a sealed vacuum-loaded container is placed, which, once pierced by the collection needle, draws in a blood sample under vacuum pressure or force through the conduit 2006 from the patient needle 2402.”), 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 argues that Rogers et al. ‘445 fails to teach the newly amended claim 1. Examiner respectfully disagrees, as the amendments include 35 U.S.C. 112(a) and 112(b) issues, which also affect the art rejection. As previously mentioned in the 35 U.S.C. 112(a) rejection, “flow restrictor” and “selectively permeable blood barrier” are used interchangeably. Thus, Rogers et al. ‘445 teaches the newly amended claim 1 (see 35 U.S.C. 102(a)(1) art rejection). As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 102(a)(1) rejection has been maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
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