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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) collecting data, comparing data, and outputting data. This judicial exception is not integrated into a practical application because these steps can be performed in the mind or carried out by a generic computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because generic collection of data, comparing and outputting are mere data gathering steps and comparing results to use the correlation do not add meaningful limitation to the method as they are insignificant extra-solution activity.
Claim Rejections - 35 USC § 102
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 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 1188126 (herein after Oldham).
Regarding claim 1, Oldham discloses a sample preparation method (fig. 1a-2b) comprising:
receiving a sample preparation specification (setup process that can be performed for each tray consistent with step 101-103, and the user may establish the set of procedures to be performed on each of multiple trays, fig. 1a, “B. Process” in specification);
defining a sample preparation based on at least the sample preparation specification (a user may enter parameters defining the protocol or protocols to be performed on that tray for each of the chosen procedures, “B. Process” in specification);
comparing the sample preparation with sample preparation validation criteria (Claim 1, step when a user selects or creates a protocol, the protocol is cross-checked for compatibility with, for example, the other protocols selected and the hardware capabilities of the associated automated work station, step 210; “B. Process” in specification);
determining that the sample preparation does not comply with the sample preparation validation criteria (“for example, if the user chooses to perform a cDNA protocol which seals the tray before performing its incubation steps, the robot is incapable of removing the seal, it would be impractical to choose as a second protocol one that requires access to the contents of the tray. This combination would be incompatible. Further, the method checks for user input errors and incompatibility such as conflicts with known bounds for known protocols, conflicts with previous parameters entered by the user in other procedures of a combination, and protocols that exceed the systems capability, Introduction and Process paragraphs);
generating at least one notification (an error message will be displayed to the user, “B. Process”); and
sending at least one command to sample preparation hardware (fig. 2b, any step of 265 or restarting the process for the next sample at the beginning, such as step 103)
Regarding claim 2, the sample preparation method of claim 1, further comprising any combination of one or more of the following: checking an error status of the sample preparation specification (Further, the method checks for user input errors and incompatibility such as conflicts with known bounds for known protocols, conflicts with previous parameters entered by the user in other procedures of a combination, and protocols that exceed the systems capability, Introduction and Process paragraphs); checking a first data about at least one white blood cells concentration; checking a first status of at least one sample preparation consumable; or checking a second status of sample preparation hardware.
Regarding claim 3, the sample preparation method of claim 1, further comprising any combination of one or more of the following: generating at least one notification (an error message will be displayed to the user, “B. Process”); or sending at least one command to the sample preparation hardware.
Regarding claim 4, the sample preparation method of claim 1, wherein the sample preparation specification is received by a sample preparation instrument via a data transfer system (network).
Regarding claim 5, the sample preparation method of claim 1, further comprising, preparing a sample using sample preparation consumables (prepared samples for DNA, RNA testing, background of invention).
Regarding claim 6, the sample preparation method of claim 1, wherein the sample preparation specification is defined by input from an operator (a user inputs data to a computer to generate a sample preparation, B. Process).
Regarding claim 7, the sample preparation method of claim 2, wherein the error status is indicated by a flag variable having a value that may be "true" or "false." (incompatible is a “false” equivalence)
Regarding claim 8, the sample preparation method of any one claim 1, wherein the sample preparation specification contains a hash code (barcode or one-up numbers, B. Process).
Regarding claim 9, the sample preparation method of claim 8, wherein the hash code is used to verify that no unauthorized modifications have been made to the sample preparation specification (the barcode is used to verify incompatibility of the sample preparation specification and the protocol parameters).
Regarding claim 10, the sample preparation method of claim 4, wherein the sending at least one command to the sample preparation hardware causes the sample preparation hardware to change the operation of the sample preparation instrument (a protocol that is deselected by a user, the remaining protocols are modified as necessary to reflect the deselection. For example fig. 3, a lysis, archive and PCR protocol are all selected. In accordance with these choices, a set of samples will be lysed, a subset of the lysed samples will be subjected to the archive protocol, and a subset of the archived samples will be used in the PCR protocol. If the lysis protocol is deselected, the input tray type will change from "Raw Sample" to "Lysed Sample," and the samples which are selected to be lysed, but not archived will be deselected. If, for example, the archive protocol is deselected, the user will be warned that the output of lysis protocol is lysed samples which cannot be used by the PCR protocol).
Regarding claim 11, the sample preparation method of claim 10, wherein the sending at least one command to the sample preparation hardware causes the sample preparation hardware to disable sample preparation from being executed (see claim 10 above with deselection of a step in a protocol. This is disabling a sample preparation step from being executed and is carried out once deselected by a user).
Regarding claim 12, the sample preparation method of claim 1, further comprising displaying an icon indicating errors on a sample preparation error status indicator (an error notification is displayed to a user via a display. What is displayed is an icon is simply an “error” message which broadly is interpreted as an icon).
Regarding claim 13, the sample preparation method of claim 1, further comprising displaying a sample preparation error window containing information about errors in a sample preparation (an error message being displayed on the display is a provided in a window of the display).
Regarding claim 14, the sample preparation method of claim 1,wherein the comparing the sample preparation with the sample preparation validation criteria comprises checking white blood cells concentration in the sample preparation against the user-input WBC range of the sample preparation specification (step 1160). A standard is a known quantity of a known biological macromolecule. The user may also select the standard quantities or concentration of each detector for each master mix, and number of replicates of DNA to be produced by the PCR procedure (step 1165). Controls for the master mix may also be set by the user (step 1170).
Regarding claim 15, the sample preparation method of claim 5, wherein the comparing the sample preparation with the sample preparation validation criteria comprises checking presence and expiration date of the sample preparation consumables (fig. 2b, steps 250,255,260, B. Process).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
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