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 .
Election/Restrictions
Applicant’s election of Group I (which includes claims 42-48) in the reply filed on 10 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claim 47 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.
Claim 47 recites the limitation "the second volume of hydrated reagent" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 42-47 are rejected under 35 U.S.C. 103 as being unpatentable over Whitacre et al. (US 2021/0018527) in view of Knight (US 2017/0341073).
Regarding claim 42, the reference Whitacre et al. discloses system comprising:
a fluid manifold (104) comprising multiple reagent nozzle sippers (112) and a bypass valve (68) (see paras. [0063]-[0064]; Figs. 2 and 4-6), the reagent nozzle sippers (112) each comprising a distal tip (115) configured to extend into a corresponding reagent well (64) (see paras. [0064]; [0070]; Figs. 4-6), the bypass valve (68) fluidly connected to the reagent nozzle sippers (112) (see para. [0053]; Figs. 2 and 4-6) and;
a pump (38) fluidly connected to the bypass valve (68) (see paras. [0057]; [0059]; Figs. 2, 6); and
a control circuitry (44) operatively connected to the reagent nozzle sippers (112), bypass valve (68), and pump (38), the control circuitry controlling the reagent nozzle sippers, the bypass valve (68), and the pump (38) to automatically mix and homogenize the reagents (see paras. [0058]; [0075]; [0101]).
The instantly claimed system appears to differ from the system disclosed in the reference Whitacre et al. in that the reference Whitacre et al. is silent with respect to utilizing the disclosed system for hydrating reagents stored in a lyophilized state within the reagent wells.
The reference Knight teaches a system comprising: a fluid manifold comprising multiple lyophilized reagent nozzle sippers (310) (see paras. [0013]; [0098]-[00104]; [0112]), the lyophilized reagent nozzle sippers (310) each comprising a distal tip and extending into a corresponding lyophilized reagent well (430) containing a lyophilized reagent (495) therein such that before hydration the distal tip does not contact the lyophilized reagent and after hydration the distal tip contacts hydrated reagent (see paras. [0102]; [0112]; Figs. 8, 9C); a pump (see paras. [0100]-[0102]); and a control circuitry operatively connected to the lyophilized reagent nozzle sippers and the pump (see paras. [0100]-[0102]), the control circuitry controlling the lyophilized reagent nozzle sippers and the pump to automatically hydrate the lyophilized reagents and homogenize the hydrated reagent (see paras. [0100]-[0102]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Whitacre et al. and Knight, and utilized the system Whitacre et al. for hydrating lyophilized reagents stored within a multi-well tray as taught by Knight, and predictably arrived at the instantly claimed system. One of ordinary skill in the art would be motivated to do so since the reference Knight teaches for the need to store a perishable liquid reagent for use in an automated biochemical assay in a lyophilized state and reconstituting the lyophilized reagent to its liquid form prior to its use by subjecting the lyophilized reagent to a hydration procedure (see paras. [0041]-[0042]).
Regarding claim 43, the references Whitacre et al. and Knight disclose that the system further comprises a bypass line (62) between the bypass valve (68) and the pump (38), wherein the bypass line (62) is fluidly connected to the pump (38) (see Whitacre et al.: para. [0052]; Fig. 2).
Regarding claim 44, the references Whitacre et al. and Knight disclose that the system further comprises a bypass cache (118) between the pump (38) and the bypass valve (68), and wherein the bypass cache (118) is fluidly connected to the bypass valve (68) (see Whitacre et al.: paras. [0053];[0054]; Figs. 2 and 4-6). The references Whitacre et al. and Knight are however silent with respect to the bypass cache (118) comprising a heating chamber. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bypass cache (118) to include a heating chamber since the reference Whitacre et al. teaches that the system may be provided with a temperature control means to control temperature of the reagents mixture (see para. [0050]).
Regarding claim 45, the references Whitacre et al. and Knight disclose the system wherein the fluid manifold (104) further comprises one or more hydration sipper (112) and each of the one or more hydration sipper (112) comprises a distal tip (115) and extends into a corresponding hydration reagent reservoir (64) containing a hydration fluid (see Knight: paras. [0101]; Whitacre et al.: para. [0064]; Fig. 2).
Regarding claim 46, the references Whitacre et al. and Knight disclose the system, wherein one or more of
(i) the control circuitry controls the pump to hydrate the lyophilized reagent by aspirating a volume of the hydration fluid and dispensing the volume of the hydration fluid onto the lyophilized reagent in the lyophilized reagent well, resulting in a hydrated reagent (see Whitacre et al.; para. [0058]; Fig. 2; Knight: paras. [0100]-[0102]);
(ii) the control circuitry controls the pump to dilute the hydrated reagent by aspirating a second volume of the hydration fluid and dispensing the second volume of hydration fluid into the lyophilized reagent well (see Whitacre et al.; para. [0058]; [0091]; Fig. 2; Knight: paras. [0100]-[0102]); and
(iii) the control circuitry controls the pump and the lyophilized reagent nozzle sipper to homogenize the hydrated reagent by positioning the lyophilized reagent nozzle sipper such that the distal tip contacts the hydrated reagent, aspirating the hydrated reagent and dispensing it back into the lyophilized reagent well, and repeating the steps of aspirating and dispensing until the hydrated reagent is substantially homogeneous (see Whitacre et al.; para. [0058]; [0091]; Fig. 2; Knight: paras. [0100]-[0102]).
Regarding claim 47, as no structural distinction is seen between the system of Whitacre et al. and Knight and the instantly claimed system, the system of Whitacre et al. and Knight is considered capable of performing the function recited in claim 47.
Allowable Subject Matter
Claim 48 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 48 would be allowable because the prior art of record does not disclose or fairly suggest the feature: wherein the control circuitry controls the pump to add a third component to the buffer well by aspirating an amount of the third component and dispensing the amount of the third component into the buffer well, as recited in claim 48.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lessanework T Seifu whose telephone number is (571)270-3153. The examiner can normally be reached M-T 9:00 am - 6:30 pm; F 9:00 am - 1:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESSANEWORK SEIFU/Primary Examiner, Art Unit 1774
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