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 § 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 1-17 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.
The preamble to claim 1 recites a fully automated sample preparation system; however, the body of claim 1 merely recites numerous elements that are unrelated and therefore do not define a “system.”
For example, the robotic arm assembly recited in claim 1, lines 4-5 merely recites a carrying mechanism to perform a predefined holding task, without relating the robotic arm assembly to the other elements listed in the body of claim 1.
Claim 9 recites “the injection valve” in lines 7 and 9. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claim 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Pearce et al. (“Automation Using Robotics in the Analysis of SK&F 94836 in Plasma,” Chemometrics and Intelligent Laboratory Systems, 3 (1988) 315-319) in view of European Patent Application Publication No. EP0259259 to Metzger et al.
Pearce et al. discloses a fully automated sample preparation system (abstract and fig. 2), comprising:
a. a cylindrical separation device (HPLC column, see abstract) for receiving a biological fluid sample and reagents;
b. a robotic arm assembly with a carrying mechanism to perform a predefined holding task (page 316, left column, I. 15-20);
c. a liquid handling system having a sampling nozzle to obtain an aliquot of a sample or reagents for the separation device (see "nozzle hand", fig. 2 and page 318, right column, "Sample processing");
d. a metrological control device having a measurement system (in at least one embodiment of the apparatus disclosed in D1, the sample was weighted (page 317, right col, last para: "Validation");
e. a mixing apparatus ("Vortex mixer", fig. 2) and
f. an injection system coupled to the separation device wherein an injection port connects a flow path in an automated sample analysis system (page 315, right col., I. 3-10).
Pearce et al. teaches a vortex mixer, but does not teach a mixing apparatus having an ultrasonic device for providing ultrasonic energy to mix and clean the sample.
Metzger et al. discloses a system for preparing samples for analysis by chromatography. (column 1, lines 5-10)
Metzger et al. teaches an ultrasonic transducer that is use to mix samples. (column 14, lines 35-45)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Pearce et al. to use a mixing apparatus having an ultrasonic device for providing ultrasonic energy to mix and clean the sample as taught by Metzger et al. as a simple substitution of one known element for another to obtain predictable results. (MPEP2143(I)(B)).
I.) Regarding applicant’s claim 1 as noted above Pearce et al. in view of Metzger et al. renders all the limitations of claim 1 obvious.
Therefore, Pearce et al. in view of Metzger et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Pearce et al. in view of Metzger et al. renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that the injection port connected to an injection system comprising:
a. a two-position injection valve;
b. a syringe pump to withdraw fluid from the separation device; and
c. a sample loop wherein the injection valve provides access to a binary pump system for automated sample analysis.
Metzger et al. teaches multiple position valves, syringes, and a sample loop. (column 12, lines 38-47; column 12 line 48 -column 13, line 11; column 17, lines 5-38)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Pearce et al, in view of Metzger et al. to include multiple position valves, syringes, and a sample loop as taught by Metzger et al. to supply sample to a chromatography analyzer.
Therefore, Pearce et al. in view of Metzger et al. renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Pearce et al. in view of Metzger et al. renders claim 1 obvious from which claim 3 depends.
Claim 3 recites that the robotic arm has a robotic gripper activated electronically or pneumatically.
Pearce et al. teaches a robotic arm and a gripper. (page 316, last sentence)
Therefore, Pearce et al. in view of Metzger et al. renders claim 3 obvious.
IV.) Regarding applicant’s claim 4, as noted above Pearce et al. in view of Metzger et al. renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that the metrological control device records the weight of a biological sample or reagent in the separation device.
As noted above, Pearce et al. teaches weighing samples.
Therefore, Pearce et al. in view of Metzger et al. renders claim 4 obvious.
V.) Regarding applicant’s claim 5, as noted above Pearce et al. in view of Metzger et al. renders claim 1 obvious from which claim 5 depends.
Claim 5 recites that the metrological control device contains a dispensation port positioned as a load receptor for setting the separation device to measure a biological sample or reagent when dispensed into the separation device.
While Pearce et al. teaches weighing samples, Pearce et al. in view of Metzger et al. does not specifically teach that the weighing device includes a dispensation port.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Pearce et al. in view of Metzger et al. to designate a location on the weighing device as a “port” to position samples to be weighed for purposes of using the robotic arm to position the samples correctly. Weighting would include load sensing.
Therefore, Pearce et al. in view of Metzger et al. renders claim 5 obvious.
VI.) Regarding applicant’s claim 6, as noted above Pearce et al. in view of Metzger et al. renders claim 5 obvious from which claim 6 depends.
Claim 6 recites the metrological control device is capable of accurate measurements of approximately 1, 0.1 or 0.01 milligrams.
Pearce et al. in view of Metzger et al. does not teach that the weighing device is capable of accurate measurements of approximately 1, 0.1 or 0.01 milligrams.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Pearce et al. in view of Metzger et al. to use a weighing device that is capable of measuring the weight of any desired sample size including weights of approximately 1, 0.1 or 0.01 milligrams.
Therefore, Pearce et al, in view of Metzger et al. renders claim 6 obvious.
VII.) Regarding applicant’s claim 7, as noted above Pearce et al. in view of Metzger et al. renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the mixing apparatus is selected from the group consisting of an ultrasonic probe, a shaker, a vortex mixer, and combinations thereof.
As noted above, Pearce et al. teaches a vortex mixer and Metzger et al. teaches an ultrasonic mixer.
Therefore, Pearce et al. in view of Metzger et al. renders claim 7 obvious.
VIII.) Regarding applicant’s claim 8, claim 8 recites:
a. A sample preparation subsystem according to claim 1;
b. A sample analysis subsystem; and
c. A control subsystem, wherein a standalone computer with software controls the integration of sample preparation and analysis.
As noted above, Pearce et al. in view of Metzger et al. renders the sample preparation system of claim 1 obvious.
Pearce et al. teaches that the samples are transferred to an AASP LC module for automated HPLC analysis. (page 316, “Manual extraction” last sentence)
Pearce et al. further teaches the use of computer control. (page 319, right hand column first paragraph)
Metzger et al. also teaches the use of computer control. (column 9, line 49-column 10, line 15; column 17, lines 39-65)
Pearce et al. in view of Metzger et al. does not teach a sample analysis subsystem and a control subsystem, wherein a standalone computer with software controls the integration of sample preparation and analysis.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Pearce et al. in view of Metzger et al. to provide the sample analysis as a subsystem for purposes of using the sample analysis with other sample preparation systems and to use a computer of any type, including a standalone computer with software to control the overall system.
Therefore, Pearce et al. in view of Metzger et al. renders claim 8 obvious.
2. Claims 9-17 are rejected under 35 USC 103 as being unpatentable over Pearce et al. in view of Metzger et al. as applied to claim 8 above and further in view of U.S. Patent No. 6,296,771 to Miroslav.
I.) Regarding applicant’s claim 9, as noted above Pearce et al. in view of Metzger et al. renders claim 8 obvious from which claim 9 depends.
Claim 9 recites that the sample analysis subsystem comprises:
a. two liquid delivering pumps for delivering mobile phases into an analytical flow path having a solvent selection valve to access different mobile phases;
b. a 2-position valve which connects with the liquid delivering pumps from downstream and selects the different mobile phases to flow through the sample loop of the injection valve; and
c. a static mixing device downstream of the injection valve to combine and mix the different mobile phase flows before entering an analytical column that is used to retain and separate one or more target components originated from the biological sample.
Pearce et al. in view of Metzger et al. does not teach:
a. two liquid delivering pumps for delivering mobile phases into an analytical flow path having a solvent selection valve to access different mobile phases;
b. a 2-position valve which connects with the liquid delivering pumps from downstream and selects the different mobile phases to flow through the sample loop of the injection valve; and
c. a static mixing device downstream of the injection valve to combine and mix the different mobile phase flows before entering an analytical column that is used to retain and separate one or more target components originated from the biological sample.
Miroslav teaches a chromatography system that includes valving that injects multiple mobile phases into different chromatography columns and valving. (column 9, lines 9-20).
Miroslav also teaches sample loops and (column 9, lines 21-28)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Pearce et al. in view of Metzger et al. to include two liquid delivery pumps to supply different mobile phases to one or more chromatography columns as taught by Miroslav for purposes of separating different analytes in respective mobile phases for analysis of the analytes.
It would have further been obvious to one of ordinary skill in the art to provide a static mixing device downstream of the injection valve to combine and mix the different mobile phase flows before entering an analytical column(s) for purposes of ensuring separation of the analytes in the column(s).
Therefore, Pearce et al. in view of Metzger et al. and Miroslav renders claim 9 obvious.
II.) Regarding applicant’s claim 10, as noted above Pearce et al. in view of Metzger et al. and Miroslav renders claim 9 obvious from which claim 10 depends.
Claim 10 recites the analytical column is a plurality of analytical columns available into an analytical flow path.
Miroslav teaches using multiple analytical columns.
Therefore, Pearce et al. in view of Metzger et al. and Miroslav renders claim 10 obvious.
III.) Regarding applicant’s claim 11, as noted above Pearce et al. in view of Metzger et al. and Miroslav renders claim 10 obvious from which claim 11 depends.
Claim 11 recites an “optional” 2-position valve to switch flow direction through an analytical column.
Claim 11 does not add any structural limitation(s) to claim 10 inasmuch as claim 11 only recites an “optional” 2-position valve.
Therefore, Pearce et al. in view of Metzger et al. and Miroslav renders claim 11 obvious via rendering claim 10 obvious.
IV.) Regarding applicant’s claim 12, as noted above Pearce et al. in view of Metzger et al. and Miroslav renders claim 10 obvious from which claim 12 depends.
Claim 12 recites a detector which detects the target components separated in the analytical column.
In Pearce et al. in view of Metzger et al. and Miroslav the use of a detector to detect target components separated by the chromatography column(s) is obvious inasmuch as these prior art reference are directed to analyzing analytes.
Therefore, Pearce et al. in view of Metzger et al. and Miroslav renders claim 12 obvious.
V.) Regarding applicant’s claim 13, as noted above Pearce et al. in view of Metzger et al. and Miroslav renders claim 8 obvious from which claim 13 depends.
Claim 13 recites that the control subsystem comprises:
a. a controller which controls operations of the sample preparation subsystem and the sample analysis subsystem to include a sample preparation configured to perform extraction with a separation device by filtration and load sample extraction into the sample loop;
b. a data structure that contains stored information pertaining to a plurality of unique assays including types of samples, a plurality of sample preparation items each of which includes a predefined set of preparation operations corresponding to one particular assay and a plurality of predefined sets of analysis operations corresponding to a particular assay; and
c. a user interface application, wherein an analyst can submit a test order by specifying a sample position and selecting a particular assay, in a random access way from a plurality of unique assays.
Miroslav teaches one or more microprocessors and one or more associated control systems or sub-systems for controlling the autosampler, injector, multi-port switching valve, and detectors, as well as the one or more pumps that supply the mobile-phase to the chromatographic columns. (column 4, lines 18-27)
It would have been obvious to one of ordinary skill in the art to modify Pearce et al. in view of Metzger et al. and Miroslav to include: a controller to control operations of the sample preparation subsystem and the sample analysis subsystem to include a sample preparation configured to perform extraction with a separation device by filtration to remove any undesirable particles and load sample extraction into the sample loop; a data structure that contains stored information pertaining to a plurality of unique assays including types of samples, a plurality of sample preparation items each of which includes a predefined set of preparation operations corresponding to one particular assay and a plurality of predefined sets of analysis operations corresponding to a particular assay for purposes of automating the use of the system; and a user interface application, wherein an analyst can submit a test order by specifying a sample position and selecting a particular assay, in a random access way from a plurality of unique assays.
Therefore, Pearce et al. in view of Metzger et al. and Miroslav renders claim 13 obvious.
VI.) Regarding applicant’s claim 14, as noted above Pearce et al. in view of Metzger et al. and Miroslav renders claim 8 obvious from which claim 14 depends.
Claim 14 recites that the analysis subsystem is a clinical diagnostic system applied in the integration of the sample preparation.
The recitation of a clinical diagnostic system in claim 14 does not further limit the structure of the system of claim 8.
Therefore, Pearce et al. in view of Metzger et al. and Miroslav renders claim 14 obvious via rendering claim 8 obvious.
VII.) Regarding applicant’s claim 15, as noted above Pearce et al. in view of Metzger et al. and Miroslav renders claim 14 obvious from which claim 15 depends.
Claim 15 recites that the sample preparation and analysis are multiple assays from a plurality of unique assays which can be selected to be performed on a sample.
Claim 15 is directed to use of the sample preparation and analysis system, but does not add any further structural limitations to claim 14 from which it depends and is not afforded patentable weight.
Therefore, Pearce et al. in view of Metzger et al. and Miroslav renders claim 15 obvious via rendering claim 14 obvious.
VIII.) Regarding applicant’s claim 16, as noted above Pearce et al. in view of Metzger et al. and Miroslav renders claim 15 obvious from which claim 16 depends.
Claim 16 recites that the multiple assays can be performed randomly in time.
Claim 16 is directed to use of the sample preparation and analysis system, but does not add any further structural limitations to claim 15 from which it depends and is not afforded patentable weight.
Therefore, Pearce et al. in view of Metzger et al. and Miroslav renders claim 16 obvious via rendering claim 15 obvious.
IX.) Regarding applicant’s claim 17, as noted above Pearce et al. in view of Metzger et al. and Miroslav renders claim 16 obvious from which claim 17 depends.
Claim 17 recites that the multiple assays do not require calibrators to routinely establish a calibration curve for quantitative analysis.
Claim 17 is directed to use of the sample preparation and analysis system, but does not add any further structural limitations to claim 16 from which it depends and is not afforded patentable weight.
Therefore, Pearce et al. in view of Metzger et al. and Miroslav renders claim 17 obvious via rendering claim 116 obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798
Prosecution Insights