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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12 and 13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 12 and 13 fail to recite any structural limitations beyond the method claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-2, 5, 7-8, 12-13 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kercso et al (US 20030017085).
Regarding claims 1, 12-13, Kercso et al teach a control method for a microfluidic testing system (Fig. 10; para. 0077-0080), the microfluidic testing system comprising
a microfluidic biochip (Fig. 5: 40),
a sample stage (Figs. 3,7: 56) for placing a sample cup (Figs. 1,7; Para. 0037, 0040: multi-well plate 12, it is noted that "sample cup" is sufficiently broad to read on a receptacle such as a well to hold sample), and
a lifting mechanism for driving the sample stage to move (Fig.3: 44),
the microfluidic biochip being provided with a sample inlet for receiving a sample liquid (Fig. 5: 46, para. 0049 ), and the control method comprising:
starting the lifting mechanism when the liquid storage tray holding the sample liquid is placed on the sample stage (Para. 0049-0051) , and
controlling the lifting mechanism to move the sample stage from an initial position to a testing position where the sample liquid in the sample cup comes into contact with the sample inlet (Para. 0049).
Regarding claims 12 and 13, do not further limit the method claims by not reciting structural limitations (see 112d rejection supra). It is noted that Kercso et al teach refrigeration (Para. 0083)
Regarding claim 2, Kercso et al teach the microfluidic testing system further comprises a buffer liquid driving device, and before starting the lifting mechanism, the control method further comprises a step of judging whether the sample cup holding the sample liquid is placed on the sample stage, and the step specifically comprises: judging whether the sample cup holding a sample is placed on the sample stage; and if yes, starting the buffer liquid driving device, and driving a buffer liquid to flow into the sample cup by the buffer liquid driving device, such that the buffer liquid is mixed with the sample in the sample cup to generate the sample liquid. (Para. 0077-0080: dilution station 24 to reconstitute sample prior to lifting to the fluid contact with the microfluidic device 40)
Regarding claim 5, Kercso et al teach wherein before judging whether the sample cup holding a sample is placed on the sample stage, the control method further comprises: judging whether the microfluidic biochip is inserted into a mounting position (Para. 0049: microfluidic device 40 in a fixed location prior to plate 12 movement) thereof , and if yes, judging whether the sample cup holding the sample is placed on the sample stage (Para. 0049: plate accurately positioned in x-y plane and once aligned lifting the plate to bring in contact with pipettor), it is noted that the "if no" scenario is not required and is considered an optional scenario.
Regarding claim 7, Kercso teach after controlling the sample stage to move from an initial position to a testing position thereof, the control method further comprises: performing a sampling operation; and when the sampling operation is finished, controlling the sample stage to return to the initial position thereof. (Para. 0078-0080: robotic arm 44 lifts to microfluidic device 40 and repeated with other plates)
Regarding claim 8, Kercso et al teach the microfluidic testing system further comprises a sample liquid driving device, and the sampling operation comprises: driving the sample liquid to flow into the microfluidic biochip through the sample inlet by the sample liquid driving device; and when the quantity of the sample liquid in the microfluidic biochip reaches a preset sample liquid volume value, finishing the sampling operation (para. 0079-0080: sample added by pipettor of microfluidic device).
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.
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.
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.
Claim(s) 3-4, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kercso et al in view of Wu (CN 111044742).
Regarding claim 3, Kercso et al teach dilution of the sample but is silent to after the sample cup holding the sample is placed on the sample stage and before the buffer liquid driving device is started, the control method further comprises: testing the weight of the sample in the sample cup; and calculating a target quantity of the buffer liquid required to be added according to the weight of the sample in the sample cup; and after starting the buffer liquid driving device, the control method further comprises: when the quantity of the buffer liquid flowing into the sample cup reaches the target quantity, stopping the buffer liquid driving device.
Wu teach after the sample cup holding the sample is placed on the sample stage and before the buffer liquid driving device is started, the control method further comprises: testing the weight of the sample in the sample cup; and calculating a target quantity of the buffer liquid required to be added according to the weight of the sample in the sample cup; and after starting the buffer liquid driving device, the control method further comprises: when the quantity of the buffer liquid flowing into the sample cup reaches the target quantity, stopping the buffer liquid driving device (p. 5 para. 8: buffer added to match the weight of the sample weighed). It is desirable to provide proper buffer for the sample to ensure proper dilution for analysis. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the buffer method above to provide the above advantage of providing proper buffer for the sample to ensure proper dilution for analysis.
Regarding claim 4, Kercso et al teach mixing (Para. 0086), but is silent to an oscillation device is further provided on the sample stage, and after stopping the buffer liquid driving device and before controlling the sample stage to move from an initial position to a testing position thereof, the control method further comprises: starting the oscillation device to oscillate the sample cup by the oscillation device; and stopping the oscillation device after the oscillation device is started for a first preset duration. Wu teach an oscillation device is further provided on the sample stage, and after stopping the buffer liquid driving device and before controlling the sample stage to move from an initial position to a testing position thereof, the control method further comprises: starting the oscillation device to oscillate the sample cup by the oscillation device; and stopping the oscillation device after the oscillation device is started for a first preset duration (p. 3 para. 11: oscillation transfer device to oscillate and transfer sample cup after adding buffer). It is desirable to provide the oscillation device method above to ensure proper mixing of the buffer and sample. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the oscillation device method above to provide the above advantage of ensuring proper mixing of the buffer and sample.
Regarding claim 6, Kercso et al teach mixing (Para. 0086), but is silent to before judging whether the microfluidic biochip is inserted into a mounting position thereof, the control method further comprises: testing the total weight of the article borne by the sample stage; and when the total weight of the article borne by the sample stage is greater than or equal to a first preset weight value, sending prompt information for instructing emptying of the sample stage. Wu teach before judging whether the microfluidic biochip is inserted into a mounting position thereof, the control method further comprises: testing the total weight of the article borne by the sample stage (p. 5 para. 8: buffer added to match the weight of the sample weighed). It is desirable to provide the testing the total weight of the article borne by the sample stage above to ensure proper the buffer and sample. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the oscillation device method above to provide the above advantage of ensuring proper amount of the buffer and sample. It is noted that "when the total weight of the article borne by the sample stage is greater than or equal to a first preset weight value, sending prompt information for instructing emptying of the sample stage" and "when the total weight of the article borne by the sample stage is less than the first preset weight value, judging whether the microfluidic biochip is inserted into the mounting position thereof" is optional.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kercso et al in view of Ye (CN205538654) and further in view of Knapp et al (US 6406893)).
Regarding claim 9, Kercso teach a pipettor such as conventional micropipettors (Para. 0057). Kercso is silent the sample liquid driving device is a micro injection pump, and the step of judging whether the quantity of the sample liquid in the microfluidic biochip reaches a preset sample liquid volume value comprises: judging whether a trigger signal for indicating that a piston of the sample liquid driving device moves to a preset position is received; and if yes, determining that the quantity of the sample liquid in the microfluidic biochip reaches the preset sample liquid volume value.
Ye teach a housing of a detector pen having a detection chamber configured to receive a microfluidic chip, and a chip interface is provided at the end of the detection chamber to communicate with a microchannel of the microfluidic chip in a plug-in manner. (Fig. 2:11 chip interface) Behind the detection chamber, a stepper motor is provided, which is fixedly connected to the piston of the cylinder by means of a coupling; rotation of the stepper motor may drive directional movement of the piston within the cylinder block; the cylinder is connected to the chip interface via a hose. Placing the microfluidic chip into a detection chamber in a detection pen during detection, the chip interfaces to the microchannels of the microfluidic chip, the stepper motor driven piston pumps away air inside the microfluidic chip channels creating negative pressure, the sample solution enters the chip under the action of ambient atmospheric pressure, the detection pen realizes full automation from sample addition to detection (p. 2 para. 11: sample liquid driving device is a micro injection pump, and a piston of the sample liquid driving device). It is desirable to provide a microfluidic chip with sample from a microinjector pump with a piston to ensure consistent volume amounts of samples.
Kercso/Ye are silent to step of judging whether the quantity of the sample liquid in the microfluidic biochip reaches a preset sample liquid volume value comprises: judging whether a trigger signal moves to a preset position is received; and if yes, determining that the quantity of the sample liquid in the microfluidic biochip reaches the preset sample liquid volume value.
Knapp et al (US 6406893) teach micropumps to permit controlled movements and controlled preselected volumes such as a measured sample slug (col. 5 lines 20-30; col. 22 line 60-65; Col. 52 lines 42-60: reads on step of judging whether the quantity of the sample liquid in the microfluidic biochip reaches a preset sample liquid volume value comprises: judging whether a trigger signal moves to a preset position is received; and if yes, determining that the quantity of the sample liquid in the microfluidic biochip reaches the preset sample liquid volume value). It is desirable perform the preset sample volume steps to ensure the proper sample volumes for the analysis. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the Knapp method to the Kercso/Ye method to provide the above advantage of ensuring the proper sample volumes for the analysis.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kercso et al in view of Kopf-Sill (US 6858185).
Regarding claims 10-11, Kercso is silent to after the sampling operation is finished, the control method further comprises: controlling the sample liquid driving device to periodically and repeatedly perform a liquid pushing and drawing operation, the liquid pushing and drawing operation comprising a liquid pushing action for promoting the sample liquid in the microfluidic biochip to flow towards the sample inlet and a liquid drawing action for promoting the sample liquid in the microfluidic biochip to flow away from the sample inlet; after the sample stage returning to the initial position thereof and before controlling the sample liquid driving device to periodically and repeatedly perform a liquid pushing and drawing operation, the control method further comprises: controlling the sample liquid driving device to perform a liquid drawing action for promoting the sample liquid in the microfluidic biochip to continue to flow towards the interior of the microfluidic biochip, so as to form a preset space margin in a section of the microfluidic biochip close to the sample inlet, the preset space margin being used for accommodating the sample liquid pushed out by the sample liquid driving device when the sample liquid driving device performs the liquid pushing action.
Kopf-Sill teach applying pressure forces to achieve fluid movements using combination of pressure forces and vacuum sources (col. 17 lines 40-65) and creating sample plugs divided into portions to flow a single ample to undergo different reaction chemistry (col. 22 lines 31-40: reads on "so as to form a preset space margin in a section of the microfluidic biochip close to the sample inlet, the preset space margin being used for accommodating the sample liquid pushed out by the sample liquid driving device when the sample liquid driving device performs the liquid pushing action"). It is desirable to provide a sample fluid control and sample plugs of Kopf-Sill to ensure the desired sample is placed in the microfluidic device for analysis. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the sample fluid control and sample plugs of Kopf-Sill to the method of Kercso to provide the above advantage of ensuring the desired sample is placed in the microfluidic device for analysis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758
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