Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
New claim 133 recites the limitation "the plurality of reagent wells" in line 1. There is insufficient antecedent basis for this limitation in the claim.
[Examiner placed a telephone call to Applicant’s attorney, Carson Smith, to offer an Examiner’s amendment, but Applicant’s attorney stated that an Office action can be submitted as more time would be needed for a response.]
Allowable Subject Matter
Claims 109-115, 117-120, and 125-132 are allowed.
Claim 133 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance.
It was not found in the prior art search a teaching or suggestion for a system comprising:
the combination of a cartridge comprising wells (i.e., a sample well and reagent well); an assay unit comprising immobilized binding reagent, wherein the cartridge is movable independent of the assay unit;
a translational stage configured to move the cartridge relative to the assay unit to place the sample well into fluid communication with the assay unit, and to place the reagent well into fluid communication with the assay unit;
an automated fluid transfer device configured to engage the enlarged second end of the assay unit and to direct transfer of the sample from the sample well and the reagent from the reagent well into the assay unit
such that a reaction occurs within the assay unit that yields a signal indicative of a presence of the analyte;
and a detection assembly arranged proximate to the assay unit when the assay unit is engaged with the automated fluid transfer device such that the detection assembly is configured to detect the signal within the assay unit.
Examiner notes that the previously cited reference, Kumar (US 5,976,896), does not disclose or suggest in one embodiment wells or containers (equivalent to assay or reagent units) that move to the capillary tubes (equivalent to assay units) as well as a detector that is arranged proximate to the assay unit to detect a signal within the assay unit when the assay unit is engaged with the automated fluid transfer device.
For example, the embodiment in Kumar in column 35, line 66 to column 36, line 16, does not have wells or sample tray that move to the capillaries (assay unit). Kumar discloses that the capillary tubes are provided in a circular manner around a cylinder and rotated to present a particular tube to a sample source or to a fluid source for washing or adding reagent, and the cylinder can also rotate to present a capillary tube to a signal generation and detection means. “Alternatively, the cylinder can cooperate with a multiwelled circular sample tray for serial or simultaneous sample removal and/or washing and expelling of fluid and even multiple signal generation and detection means. The circularly spaced apart capillary tubes can encircle a central syringe that is in fluid communication with the capillary tubes and draws fluid into the capillary tubes and/or advances fluid from the capillary tubes into any chambers and/or reaction sites on the surface of the capillary tubes.” (Kumar, in col. 35, line 66 to col. 36, line 16). Thus there is no teaching or suggestion in this embodiment for moving the wells or reagent/sample containers to the capillary tubes in Kumar.
In the embodiment in column 32, lines 20-46 wherein the sample tray (equivalent to Applicant’s cartridge with sample or reagent units) are moved to the cartridge of capillaries, the detector is not arranged to detect a signal within the assay unit when the assay unit is engaged with the fluid transfer device, since the syringe (210) (equivalent to a fluid transfer device) is provided at a separate location from the detection station (203) (see fig. 13, for example.)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
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/Ann Montgomery/Primary Examiner, Art Unit 1678
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