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 .
DETAILED ACTION
Status of Claims
Claims 1-27 and 29-32 are pending. Claims 1-16 remain withdrawn as drawn to a non-elected invention. Claims 17-18, 22-23, 25, 27, and 30-31 have been amended. Claims 17-27 and 29-32 have been examined.
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 17-27 and 29-32 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.
Claim 17 is confusing because it states that the transport is a linear path and that the wells are reciprocated along the linear path to impart a rotational component. However, given that the transport is a linear path, and no properties of the reaction wells have been provided, it is unclear what is producing the rotational component of movement to the contents of the reaction wells. Examiner suggests providing language regarding the structural configuration of the reaction well that allows a rotational component to be produced to the contents, for example, the trapezium-shaped cross-section.
Claim 17 is confusing because it states withdrawing reagent from the reagent holders, dispensing the withdrawn reagent into one of the reaction wells and then later discusses the binding between one of the labelled reagent and the magnetic reagent, however it is unclear from the claims if one or both of the labelled reagent and/or the magnetic reagent are dispensed into the reaction wells. Claim 19 seems to clarify that both reagents are ultimately dispensed sequentially into the reaction wells during first and second mixing periods but this is not clear from the language of claim 1, which provides more confusion since the magnetic field is then described as drawing the magnetic reagent and any labeled reagent/analyte towards a closed end of the reaction well. Clarification is requested.
Claim 21 recites that the labelled reagent further comprises a first particle and this is confusing because claim 1 has stated that the labelled reagent is in the form of micro-particles so it is unclear if there is an additional particle included with the labelled reagent.
Response to Arguments
Applicant’s arguments filed 04/08/2026 have been considered and are found to be persuasive in view of the amendments. Yabutani in view of Rosmalen fail to teach the claimed invention and more specifically fail to teach an immunoassay method for quantitatively measuring an amount of an analyte in a fluid sample, comprising: providing a transport that moves along a linear path; providing a set of reaction wells holding a fluid sample; mounting the set of reaction wells to the transport; providing in respective ones of two reagent holders a) a labelled reagent including one of a binding pair coupled with an antibody or an antigen, and b) a magnetic reagent coupled with the other of the binding pair, wherein both the labelled reagent and the magnetic reagent are in the form of micro-particles; operating a dispenser for withdrawing reagent from reagent holders; coordinating movement of the transport with operation of the dispenser to dispense the withdrawn reagent into ones of the reaction wells, and, operating the transport to reciprocate the set of reaction wells for a predetermined period of time along the linear path, thereby imparting a rotational component of movement to the contents of the set of reaction wells for mixing the fluid sample with the reagents, such that the analyte forms a binding to one of the labelled reagent and the magnetic reagent, said binding inhibits binding between the labelled reagent and the magnetic reagent; applying a magnetic field in a magnetization direction to the contents of the set of reaction wells to draw the magnetic reagent and any labelled reagent or analyte bound thereto toward a closed end of each reaction well, and operating a photosensitive detector to quantitatively determine the amount of the analyte, by measuring an intensity of signal associated with unbound labelled reagent suspended in the fluid contents within the reaction wells.
However, the examined claims remain unpatentable based on the 112 indefinite rejections described above.
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 REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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