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(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 5-7 and 18 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.
As to claims 5-7, which depend from independent claim 1 it appears that the “positioning unit” is used to position the opening, however dependent claims 5-7 appear to claim the “control unit” moves the opening. It is unclear what is being used to position the opening.
As to claim 18, it is unclear how the fluid is delivered at “determined time points”. Further, it appears that this claim is directed to a method of using the system as it is claimed as the system being configured to perform the function, rather than active structural limitations further limiting the system, making it unclear how this claim further limits the system. If this process is automated by the control unit, there is no mention of the control unit in independent claim 1 on which 18 depends upon.
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) 1-4, 7, 10-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US-20140011226-A1 (Bernick).
As to claim 1, Bernick teaches a system (100, Fig. 1) for handling dispersed microscopic objects contained in a sample fluid [0006-9], comprising:
a first microfluidic device (100, Fig. 1) comprising a microchannel (160) with an inlet (132), an outlet ([0035] teaches a given opening may serve as an outlet from and/or an inlet into the probe tip 104, Fig.1) and an opening (124), the opening being located between the inlet and the outlet (Fig. 1 shows it as positioned in between inlet and outlet);
a conveying device (148 Fig. 1) configured to pump a carrier fluid via the inlet ([0037] teaches 148 as pump, [0044] teaches injecting isolator fluid) into the microchannel with an input volumetric flow rate (Qin) ([0045] teaches the flow rate of the microchannels is controlled by the pumps) and to remove fluid from the microchannel via the outlet with an output volumetric flow rate (Qout) [0046];
wherein the cross section of the opening is configured such that, if the opening is in the sample fluid, the following conditions are fulfilled
a) if the input volumetric flow rate (Qin) is equal to the output volumetric flow rate (Qout), i.e. Qin= Qout, no carrier fluid emerges from the opening into the sample fluid and no sample fluid enters the microchannel ([0050] teaches isolator fluid may be pumped such that it flows through the common junction 878 and into the first microchannel 116),
b) if the output volumetric flow rate (Qout) is greater than the input volumetric flow rate (Qin), i.e. Qout> Qin ([0045] teaches the flow rate of the microchannels is controlled by the pumps), sample fluid enters the microchannel via the opening so that it is embedded as one or more compartments of sample fluid (Fig. 8)[0018] in the flow of the carrier fluid ([0050] teaches to acquire a series of sample plugs 872 from different cells isolated by intervening isolator plugs 874);
wherein the system is configured for a takeup mode in which, at least intermittently, the output volumetric flow rate (Qout) is greater than the input volumetric flow rate (Qin), i.e. Qout> Qin ([0045] teaches the flow rate of the microchannels is controlled by the pumps), so that the system provides a flow of carrier fluid from the inlet through the microchannel and past the opening to the outlet and sequentially takes up one or more compartments (Fig. 8)[0018] of sample fluid into the flow of the carrier fluid with a takeup volumetric flow rate (Qtakeup) ([0050] to acquire a series of sample plugs 872 from different cells isolated by intervening isolator plugs 874, [0053]);
wherein the system further comprises:
a first sensor unit (1024, Fig. 10)[0057] for identifying positions of the dispersed objects in the sample fluid ([0057] teaches sensor may detect each sample plug 1072), including a position of a target object selected from the dispersed objects ([0057], [0059] teaches may identify types of plugs); and
a positioning unit configured ([0042] teaches staging device) to position the opening at a target position ([0042] teaches staging device moves probe tip 204 or move the cells relative to the probe tip 204, Fig. 2) proximate the position of the target object such that the target object is drawn into the microchannel together with a certain volume of sample fluid and thereby embedded with the sample fluid in the carrier fluid as a compartment [0042].
As to claim 2, Bernick teaches the system according to claim l, wherein the system is configured to take up microscopic objects dispersed across a support surface, wherein the support surface is the bottom surface of a container in which the sample fluid is contained ([0042] teaches cell holder such as glass slide, dish, or multi-well plate).
As to claim 3, Bernick teaches the system according to claim l, wherein the system comprises a control unit ([0066] teaches controller 1840).
As to claim 4, Bernick teaches the system according to the claim 3, wherein the control unit (1840 controller, Fig. 18) is configured to identify one or more target objects among the dispersed objects from first sensor data created by the first sensor unit (detector 1830, Fig. 18) by an object recognition algorithm ([0036] teaches functional device performs operation such as measurement, detection, analysis, [0057] teaches sensor 1024 detects each plug and produces output signal, [0066] teaches a detector 1830 and a system controller 1840 such as a processor based controller, which is capable of executing an object recognition algorithm).
As to claim 7, Bernick teaches the system according to claim 3, wherein the control unit (staging device 1820 connected to controller 1840 Fig. 18, [0042]) is configured to, at least intermittently, change a travel path of the opening between a pair of consecutive target objects during the takeup mode ([0007] teaches aspiration), wherein the travel path is adjusted according to a distance between the pair of target objects ([0066] teaches multi-axis (x-y-z) staging device, therefore it is capable of changing the travel path of the opening as needed).
As to claim 10, Bernick teaches the system according to claim 1, wherein the microchannel comprises a manipulation inlet (additional microchannel 1204 Fig. 12, [0060]) arranged at the opening or between the opening and the outlet, and
wherein the system is configured to deliver a manipulation fluid ([0055] teaches to supply fluid) via the manipulation inlet (Fig. 12) into a respective compartment in the microchannel (Fig. 12) at a manipulation volumetric flow rate (Qmanip) wherein the fluid delivered via the manipulation inlet is selected from one or a combination of:
a gas to be metabolized by the objects, a liquid containing a growth stimulator for the objects, a liquid containing one or more type of bacteria, a liquid containing culture media composed of nutrition and pH-Buffer components, a liquid containing an enzyme, a liquid containing ingredients for digestion of the object, parts of the object or liberation of surface bound molecules, a liquid containing compounds for analytical assay purposes, a liquid containing a PCR mix, a liquid containing antibodies, a liquid containing nanomaterials for surface-enhanced Raman spectroscopy, a liquid containing particles and a liquid containing marker substances ([0065] teaches the isolation fluid may include a labeling agent).
As to claim 11, Bernick teaches a system according to claim 1, wherein
the system comprises a container forming a support surface [0042], wherein the system is configured to take up the microscopic objects when dispersed across the support surface ([0046] teaches aspirating sample plugs), wherein the support surface comprises a structure for prearranging the microscopic objects [0042], the structure comprising a plurality of wells ([0042] teaches multi-well plate).
As to claim 12, the combination teaches the system according to claim l, the system comprising a storage configured to accommodate the target object(s) (Fig. 6 and 8, [0018][0042]) while embedded with the sample fluid in the carrier fluid for one or more of storage (Fig. 6 and 8), cultivation and further treatment of the target object(s), wherein the one or more of storage [0018][0042], cultivation and further treatment of the target object(s) occurs within a microchannel (Fig. 8 [0018] teaches storage in microchannels, and Fig. 6 [0047]).
As to claim 13, Bernick teaches the system according to claim l, wherein the system comprises a microfluidic deposition device (100, Fig. 1) for depositing the one or more target objects at target sites ([0065] teaches injecting), wherein the deposition device comprises a microchannel (116, 120) with an opening (824 Fig. 8 ) and at least one inlet (Fig. 8), wherein a plurality of compartments (Fig. 8) of sample fluid embedded in a carrier fluid are flown via the inlet to the opening (Fig. 8)[0018], wherein at least some of the compartments of sample fluid are dispensed through the opening and deposited on a target surface ([0065] teaches injecting into cell).
As to claim 14, Bernick teaches the system according to claim l, wherein
the system is configured to deliver a support fluid via a manipulation inlet (an additional microchannel (1128, Fig. 11) for supplying fluid [0059]) of the deposition device into the microchannel (Fig. 11) of the deposition device to squeeze a compartment of sample fluid located proximate to the opening of the deposition device out of the microchannel of the deposition device through the opening (the device of Bernick has an inlet to provide fluid and is therefore capable of being used in this manner).
As to claim 15, Bernick teaches a method for picking microscopic objects by suction [0007], comprising the steps:
a) providing a sample of dispersed microscopic objects contained in a sample fluid ([0046] cell with sample plugs);
b) providing a first microfluidic device (100, Fig. 1) comprising a microchannel (116, 120) with an inlet (132), an outlet ([0035] teaches a given opening may serve as an outlet from and/or an inlet into the probe tip 104, Fig.1) and an opening (124) located between the inlet and the outlet (Fig. 1);
c) providing a carrier fluid ([0044] teaches injecting isolator fluid) that is immiscible with the sample fluid [0044] via the inlet to the microchannel at an input volumetric flow rate (Qin) and removing fluid from the microchannel via the outlet at an output volumetric flow rate (Qout) ([0045] teaches pumps control flow rates);
d) positioning the opening in the sample fluid [0066];
e) setting the input volumetric flow rate (Qin) to be smaller than the output volumetric flow rate (Qout), the difference resulting in a takeup volumetric flow rate (Qtakeup) ([0045] teaches controlling flow rate as needed for various stages of operation) of sample fluid through the opening that results in compartments (Fig. 8) of sample fluid embedded in the carrier fluid [0018],
f) changing a position of the opening relative to a target object from a starting relative position to a target position to bring the opening proximate to the target object [0066];
g) drawing the target object into the microchannel together with a respective compartment of sample fluid when embedding the compartment of sample fluid in the carrier fluid according to step e) [0018][0050].
As to claim 16, Bernick teaches the system according to claim 2, wherein the system comprises the container ([0042] teaches cell holder, dish, multi-well plate).
As to claim 17, Bernick teaches the system according to claim l, wherein the system comprises a container forming a support surface [0042][0050] wherein the system is configured to take up the microscopic objects when dispersed across the support surface [0007], wherein the support surface comprises a structure for prearranging the microscopic objects ([0042] teaches multi-well plate), the structure comprising one or more elongated grooves ([0042] teaches multi-well plate).
As to claim 18, Bernick teaches system according to claim l, wherein the system is configured to deliver a support fluid via a manipulation inlet (additional microchannel 1204 Fig. 12, [0060]) of the deposition device (100) into the microchannel (Fig. 12) of the deposition device at determined time points to squeeze a compartment of sample fluid located ([0055] teaches to supply fluid) proximate to the opening of the deposition device out of the microchannel of the deposition device through the opening.
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.
Claims 5-6, 19 are rejected under 35 U.S.C. 103 as being unpatentable over US-20140011226-A1 (Bernick) in light of US-20150231635-A1 (Okano).
As to claims 5 and 6, Bernick teaches the system according to claim 3.
As to claim 5, Bernick is silent to: the control unit being configured to move the opening at a velocity (Vopening) towards the target object, wherein the velocity (Vopening) is selected such that the takeup volumetric flow rate (Qtakeup) compensates or substantially compensates for a displacement of sample fluid towards the target object caused by moving the first microfluidic device through the sample fluid.
As to claim 6, Bernick is silent to: wherein the control unit is configured to, at least intermittently, change a velocity at which the opening is moved (Vopening) between a plurality of consecutive target objects during the takeup mode, wherein the velocity is adjusted according to a distance between each pair of consecutive target objects.
Okano teaches a method and an apparatus for separating and handling a target cell [0017] with a moving stage of adjustable velocity [0452].
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 prior art of Bernick to have adjustable velocity for the stage in order to be able to compensate for the variable speed at which the target objects might be flowing.
As to claim 19, Bernick teaches the system according to claim l.
Bernick is silent to: wherein the system comprises a target surface for depositing the object(s), wherein the target surface comprises areas that are more wettable by the sample fluid than by the carrier fluid ([0044] teaches treated, e.g. anti-wetting or hydrophobic properties).
However, Okano teaches various surface treatment options such as hydrophilic treatment [0396], oxygen plasma treatment [0887], biotinylation [0243].
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 prior art of Bernick to include treating the target surface as suggested by Okano in order to be able to deposit the samples in desired areas.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over US-20140011226-A1 (Bernick) in light of US-20120079895-A1 (Schober).
As to claims 8 and 9, Bernick teaches the system according to claim 3.
As to claim 8, Bernick teaches wherein the microchannel comprises one or more additional inlets (1204 Fig. 12) for additionally providing a fluid (an additional microchannel (1204, Fig. 12 [0061] for supplying fluid), via the one or more additional inlets to the microchannel at an additional volumetric flow rate (Qadd).
As to claim 8 and 9 Bernick is silent to: wherein the control unit is configured, during takeup mode, to intermittently change the additional volumetric flow rate (Qadd) to be essentially equal to the absolute value of the difference (IQm - Qoutl) of the input volumetric flow rate (Qin) and the output volumetric flow rate (Qout) to prevent takeup of sample fluid through the opening.
As to claim 9 Bernick is silent to: wherein the control unit is configured to intermittently vary the input volumetric flow rate (Qin) during takeup mode in order to prevent the formation of one or more empty compartments of sample fluid when the opening is not proximate to a particle or one or more particles proximate to the opening are not to be drawn into the microchannel.
However, Schober teaches a control unit that controls the conveyance device [0013].
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 prior art of Bernick to have the system controller (1840, [0066] of Bernick) control the pumps in order to be able to select and control the flow rates more easily and prevent unwanted aspiration or injection.
Claims 1-3, 9, 11, 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over US-20120079895-A1 (Schober) in light of US-20140011226-A1 (Bernick).
As to claim 1, Schober teaches a system for handling dispersed microscopic objects contained in a sample fluid (Fig. 2), comprising:
a first microfluidic device comprising a microchannel (01, Fig. 1 and 2) with an inlet (02, Fig. 2), an outlet (03, Fig. 2) and an opening (04, Fig. 1 and 2), the opening being located between the inlet and the outlet (Fig. 1 and 2);
a conveying device ([0012], [0027-28]) configured to pump a carrier fluid via the inlet ([0012], [0027-28]) into the microchannel with an input volumetric flow rate (Qin) [0032] and to remove fluid from the microchannel via the outlet with an output volumetric flow rate (Qout) [0032];
wherein the cross section of the opening is configured such that, if the opening is in the sample fluid, the following conditions are fulfilled
a) if the input volumetric flow rate (Qin) is equal to the output volumetric flow rate (Qout), i.e. Qin= Qout, no carrier fluid emerges from the opening into the sample fluid and no sample fluid enters the microchannel [0013],
b) if the output volumetric flow rate (Qout) is greater than the input volumetric flow rate (Qin), i.e. Qout> Qin, sample fluid enters the microchannel via the opening [0013] so that it is embedded as one or more compartments of sample fluid in the flow of the carrier fluid [0013];
wherein the system is configured for a takeup mode in which, at least intermittently, the output volumetric flow rate (Qout) is greater than the input volumetric flow rate (Qin), i.e. Qout> Qin, so that the system provides a flow of carrier fluid from the inlet through the microchannel and past the opening to the outlet and sequentially takes up one or more compartments of sample fluid into the flow of the carrier fluid with a takeup volumetric flow rate (Qtakeup);
wherein the system further comprises:
a first sensor unit ([0038-39], Fig. 7 and 8) for identifying positions of the dispersed objects in the sample fluid [0038], including a position of a target object selected from the dispersed objects [0038]; and
Schober is silent to: a positioning unit configured to position the opening at a target position proximate the position of the target object such that the target object is drawn into the microchannel together with a certain volume of sample fluid and thereby embedded with the sample fluid in the carrier fluid as a compartment.
However, Bernick teaches a system and method for sampling cells, addition and extraction of fluids, comprising microchannels. Bernick teaches a positioning unit (staging device [0042]) that moves the probe tip relative to the cells [0042], ([0066] teaches staging device 1820 Fig. 18).
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 prior art of Schober to include the positioning unit of Bernick in order to be able to draw selected objects into the microchannel [0067].
As to claim 15, the subject matter of claims 1 and 15 relate in that the technical features
of apparatus claim 1 are in each case suitable for implementing the method of claim 15, therefore the method is inherent, in view of the apparatus claim 1.
As to claim 2, the combination teaches the system according to claim l, wherein the system is configured to take up microscopic objects dispersed across a support surface (Fig. 5), wherein the support surface is the bottom surface of a container in which the sample fluid is contained ([0012][0035] of Schober).
As to claim 3, the combination teaches the system according to claim l, wherein the system comprises a control unit ([0013] of Schober).
As to claim 9, the combination teaches the system according to claim 3, wherein the control unit is configured to intermittently vary the input volumetric flow rate (Qin) ([0013] teaches the control unit controls the conveyance device) during takeup mode in order to prevent the formation of one or more empty compartments of sample fluid when the opening is not proximate to a particle or one or more particles proximate to the opening are not to be drawn into the microchannel (the prior art of Schober is therefore capable of being used in this manner).
As to claim 11, the combination teaches the system according to claim 1, wherein
the system comprises a container forming a support surface, wherein the system is configured to take up the microscopic objects when dispersed across the support surface ([0027] teaches suction fluid sample into microchannel), wherein the support surface comprises a structure for prearranging the microscopic objects, the structure comprising a plurality of wells ([0008] teaches microtiter plates or similar containers).
As to claim 16, the combination teaches the system according to claim 2, wherein the system comprises the container ([0008][0012]).
As to claim 17, the combination teaches the system according to claim l, wherein the system comprises a container forming a support surface [0008], wherein the system is configured to take up the microscopic objects when dispersed across the support surface ([0027] teaches suction fluid sample into microchannel), wherein the support surface comprises a structure for prearranging the microscopic objects, the structure comprising one or more elongated grooves ([0008] teaches microtiter plates or similar containers).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Maya Hendija whose telephone number is (571)272-0269. The examiner can normally be reached M-F 08:00-16:00 (MST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kara Geisel can be reached at (571) 272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAYA HENDIJA/ Examiner, Art Unit 2877
/Kara E. Geisel/ Supervisory Patent Examiner, Art Unit 2877
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