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 3, 8-9, 20 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.
Claim 3 recites the limitation "the different fluid dissolved in first fluid" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, examiner reads the phrase as “the different fluid dispersed in first fluid” corresponding to parent claim 1, line 4.
Claims 8-9 recite the limitation “the second threshold” in lines 3 & 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, examiner reads the phrase as “a second threshold” as seen in claim 7.
Claim 20 recites the limitation “the main flow” in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, examiner reads the phrase as “a main flow” similar to claim 19.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ness et al (United States Patent Application Publication 20120194805) in view of Coble et al (United States Patent 4681569), the combination of which is hereafter referred to as “NC”.
As to claim 1, Ness teaches a sensor (Abstract “System, including methods and apparatus, for light detection and signal processing for droplet-based assays.”) comprising:
a microfluidic channel sized to receive a flow of fluid (Figure 2, paragraph 0044 “channel 76”), wherein the microfluidic channel has a cross-sectional area sized to receive one liquid droplet at a time when a liquid droplet of a different liquid of a predetermined size is dispersed in the fluid (Figure 2, paragraph 0044 “droplets 74” and paragraph 052 “The droplets may travel through the examination region in single file and spaced from each other, to permit detection of light from individual droplets as each passes through the examination region.”, paragraph 0045 “The droplets may have any suitable diameter relative to the channel.”);
a light source positioned outside the microfluidic channel (Figure 2, paragraph 0044 “illumination assembly 78”), the light source configured to generate light in a selected frequency band such that the droplets have a different absorbance than the different liquid in the selected frequency band (paragraph 0046 “Each light source may be an excitation source configured to emit radiation at a particular wavelength or range of wavelengths. Each source in a multiple source excitation system may (or may not) be configured to emit radiation having a different spectral signature, to react with fluorophores that are responsive to those various signatures.”);
a light detector (Figure 2, paragraph 0047 “Collection assembly 80”) sensitive to the selected frequency band, the light detector positioned outside the microfluidic channel and configured to provide a signal representing an amount of light remaining after passing through the microfluidic channel (paragraph 0047 “Collection assembly 80 gathers and detects light from channel 76, such as light produced in response to illumination of the channel by illumination assembly 78.” and paragraph 0043 “Detection generally may be performed using any technique(s) or mechanism(s) capable of yielding, or being processed to yield, the desired information. These mechanisms may include optical techniques (e.g., measuring absorbance,”);
a light aperture positioned between the light source and the light detector, wherein light from the light source passing through the light aperture forms a light beam defining a beam axis that extends through the light source, the microfluidic channel, and the light detector (Figure 9, paragraph 0094 “The illumination optics may include an aperture element 318 that defines a slit 320.”), and wherein a width of the light aperture and the light detector define a sensing area (paragraph 0097 “The slit may have any suitable width, based on the desired volume of channel 76 to be illuminated”); and
a controller operably connected to the light detector and configured to determine a [property] based on the signal from the light detector representing the amount of light from the light source remaining after passing through the microfluidic channel and the light aperture (paragraph 0042 “ The detection of droplets themselves may include determining the presence or absence of a droplet (or a plurality of droplets) and/or a characteristic(s) of the droplet, such as its size (e.g., radius or volume), shape, type, and/or aggregation state, among others.”).
While Ness teaches detecting droplets (paragraph 0042 “determining the presence or absence of a droplet (or a plurality of droplets) “), Ness does not teach the determined property of the droplet is a droplet rate through the sensing area of the channel. However, it is known in the art as taught by Coble. Coble teaches detecting droplets (column 3:51-56 “The rate meter functions to measure flow rate of an IV administration system by detecting each drop of fluid as it falls downwardly through the drip chamber. This is accomplished by transmitting light beams across the drip path and detecting aberations in the light received as affected when drops pass through light beams.”) and determining a droplet rate through the sensing area of the channel (column 1:25-27 “the flow rate is commonly determined by measuring the drop rate frequency and converting it to volume flow rate”, and while Coble requires a known drop size (column 1:27-28 “the drop size for each IV set is known”), Ness teaches determining drop size (paragraph 0042 “The detection of droplets themselves may include determining …its size” so Ness provides the information the teachings of Coble require). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the determined property of the droplet is a droplet rate through the sensing area of the channel, in order to more easily calculate the rate of flow.
As to claim 2, NC teaches everything claimed, as applied above in claim 1, in addition Coble teaches the controller is further configured to determine an amount of the different liquid in droplet form per unit volume of fluid based on the signal (column 2:49-51 “The rate of flow of fluid is determined by two factors, that is, the number of drops per minute, and the volumetric size of each drop.”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the controller be further configured to determine an amount of the different liquid in droplet form per unit volume of fluid based on the signal, in order to more accurately determine how much medicine is being given over time.
As to claim 3, NC teaches everything claimed, as applied above in claim 2, in addition Ness teaches the amount excludes the different fluid [dispersed] in first fluid (paragraph 0035 “Light detected from each wavelength or waveband may report the presence or absence of a different target in individual droplets.”, see also paragraph 0038).
As to claim 4, NC teaches everything claimed, as applied above in claim 1, in addition Ness teaches the controller is further configured to detect a droplet rate or a droplet size of one or more droplets of the different fluid dispersed in the flow of the fluid based on the signal (paragraph 0042 “The detection of droplets themselves may include determining … its size”).
As to claim 5, NC teaches everything claimed, as applied above in claim 4, in addition Ness teaches the controller is further configured to determine the droplet rate or the droplet size based on at least one of: a magnitude of a pulse contained within the signal (Figure 3, paragraph 0060 “the feedback loop can maintain a more uniform intensity of illumination, because any effect of spectral change on illumination intensity is measured by the sensor” teaches the importance of a stable light source because variations in intensity alter the measured intensity) and a width of a pulse contained within the signal.
As to claim 6, NC teaches everything claimed, as applied above in claim 4, in addition Ness teaches the controller is further configured to determine the droplet rate or the droplet size based on a first threshold signal level for detecting a minimum size droplet in the sensing area (paragraph 0042 teaches “The detection of droplets themselves may include determining the presence or absence of a droplet” and it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to look at the signal and determine a difference between “presence” and “absence” of a droplet, i.e. use a threshold, and once the presence of a droplet is determined to perform the claimed actions, see the rejections for claims 1 and 4 above).
As to claim 7, NC teaches everything claimed, as applied above in claim 4, with the exception of the controller is further configured to determine the droplet rate or the droplet size based on a second threshold signal level for detecting a droplet that fills the sensing area. However, Ness teaches teaches droplet vs channel size and the possible change in intensity based on droplet position (paragraph 0045 “some of the droplets may be off-center when they are detected, which may change the signal intensity”) indicating droplet size & position relative to the channel affect the detected intensity. As the droplet position in the sensing area is a results effective variable and there are a finite number of possible positions, it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to enable the claimed second threshold, in order to discard droplets that are sufficiently within the sensing area to register as being present, but not sufficiently within the sensing area to provide useful data. See MPEP 2144.05(II).
As to claims 8-10, NC teaches everything claimed, as applied above in claim 4, with the exception of the claimed determination based on threshold levels. However, Ness teaches determining droplet size (paragraph 0042 “The detection of droplets themselves may include determining … its size”) and performing signal processing (Figure 11, paragraph 0109 “Signal values corresponding to each droplet region 414, from each separate signal, indicated at 416, 418, may be processed selectively relative to other signal values, as indicated in graphs 386, 388. This selective processing may ignore any signal values, not shown in the graphs, disposed outside of identified droplet regions. The selective processing may determine whether a target represented by each separate signal is present or absent in droplets corresponding to the droplet regions.”), and detecting the intensity of the signal (Figure 3, paragraph 0060 “the feedback loop can maintain a more uniform intensity of illumination, because any effect of spectral change on illumination intensity is measured by the sensor” teaches the importance of a stable light source because variations in intensity alter the measured intensity). As such paragraph 0109’s ‘may ignore any signal values’ is interpreted to read on the use of thresholds in the process of determining size, and it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to use thresholds in the claimed manner, in order to remove unreliable data and improve the reliability of the measurement. See MPEP 2144.05(II).
As to claim 11, NC teaches everything claimed, as applied above in claim 5, in addition Coble teaches the controller is further configured to determine an amount of the different liquid in droplet form per unit volume of fluid based on the droplet rate (Abstract “computing a volumetric flow rate based on the frequency of detected drops”) and droplet size (while Coble assumes a known size (column 1:27-28 “the drop size for each IV set is known”), Ness teaches determining drop size (paragraph 0042 “The detection of droplets themselves may include determining …its size” and applying the teachings of Coble to the invention of Ness would read on the claimed limitation). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to determine an amount of the different liquid in droplet form per unit volume of fluid based on the droplet rate, in order to more accurately calculate the amount of a substance being delivered to a patient.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over NC, and further in view of Ohshima et al (United States Patent Application Publication 20060231963).
As to claim 12, NC teaches everything claimed, as applied above in claim 5, with the exception of the controller is further configured to determine the droplet size based on the droplet rate. However, it is known in the art as taught by Ohshima. Ohshima teaches creating a stream of particles (Figure 1, Abstract “the fluid II exhausted from the tip (21a) of the inner pipe (21) becomes a droplet (3) having a in approximately spherical shape surrounded by the fluid I within the outer pipe (11)”) in which the droplet size is determined based on the droplet rate (paragraph 0115 “the diameter of the droplet 3 is calculated from the flow amount of the dispersion phase and the producing period of the droplet”). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to determine the droplet size based on the droplet rate, in order to more easily get a particle size.
Claims 13-16, 18 are rejected under 35 U.S.C. 103 as being unpatentable over NC, and further in view of Matsumoto (United States Patent 5690895).
As to claim 13, NC teaches everything claimed, as applied above in claim 1, with the exception of the microfluidic channel is defined between two or more optical components selected from: the light source, the light detector, the light aperture, a light channel, a lens, and a separate microfluidic channel substrate. However, it is known in the art as taught by Matsumoto. Matsumoto teaches a flow cell (Figure 4, Abstract “A flow cell apparatus, useful in an apparatus for measuring particles suspended in a liquid”) wherein the microfluidic channel is defined between two or more optical components selected from: the light source, the light detector, the light aperture, a light channel, a lens, and a separate microfluidic channel substrate (Figure 4 is an exploded view, with elements 12 narrowing the channel in the middle and elements 13 being interpreted as the claimed substrate). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the microfluidic channel be defined between two or more optical components selected from: the light source, the light detector, the light aperture, a light channel, a lens, and a separate microfluidic channel substrate, in order to better guide particles to a desired examination region.
As to claim 14, NC in view of Matsumoto teaches everything claimed, as applied above in claim 1, in addition Matsumoto teaches the microfluidic channel comprises a converging-diverging nozzle (Figures 4 and 6, the channel narrows then gets larger). It would have been obvious to one of ordinary skill in the art at the time of filing to have the microfluidic channel comprise a converging-diverging nozzle, in order to create a stable flow with known dimensions.
As to claim 15, NC in view of Matsumoto teaches everything claimed, as applied above in claim 14, in addition Matsumoto teaches the converging-diverging nozzle of the microfluidic channel comprises a contracting inlet portion and an expanding outlet portion along a flow direction (Figure 6 shows the fluid flow through the channel of Figure 4, in which the flow narrows in region 1b and expands in region 1d). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the converging-diverging nozzle of the microfluidic channel comprise a contracting inlet portion and an expanding outlet portion along a flow direction, in order to better shape the flow in a desired manner.
As to claim 16, NC in view of Matsumoto teaches everything claimed, as applied above in claim 15, in addition Matsumoto teaches a length of the contracting inlet portion is shorter than a length of the expanding outlet portion (Figure 4 shows element 12 with a longer trailing side, and Figure 6 element 1d is longer than element 1b). it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have a length of the contracting inlet portion be shorter than a length of the expanding outlet portion, in order to better control downstream flow, e.g. to manage turbulence.
As to claim 18, NC in view of Matsumoto teaches everything claimed, as applied above in claim 14, with the exception of the converging-diverging nozzle is configured to minimize flow separation and pressure drop through the microfluidic channel. However, Matsumoto teaches flow problems (column 2:44-46 “there is a fear that the sample flow will fall into turbulence not to be uniform in thickness and to be uneven in the velocity distribution”), how to overcome it (column 8:49-52 “The nozzle 3 is provided with guides 16 which prevent turbulence of the flow of the sample liquid at the sample discharge port 19 and serve to keep the sample flow having a constant width.”), the optimization of the flow (column 8:56-59 “through adjustment of the distance between the guides 16, the sample flow 23 can be set at a suitable width which is optimum for the imaging portion 21.”, see Figures 34-35 for adjustable width), and the use of pressure in sheath flow (column 7:62-65 “The sample flow 23 in the sheath flow flows while having a thin, wide and flat cross section due to pressure applied from the upper and lower sheath flows.”), and such teachings are interpreted to read on the claimed limitations. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the converging-diverging nozzle be configured to minimize flow separation and pressure drop through the microfluidic channel, in order to more accurately and efficiently measure the sample.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over NC, and further in view of Poher et al (United States Patent Application Publication 20130323757).
As to claim 17, NC teaches everything claimed, as applied above in claim 1, with the exception of another microfluidic channel positioned between the light source and the light detector. However, it is known in the art as taught by Poher. Poher teaches measuring particle speed (paragraph 0001 “The present invention relates to a method for characterizing a variation in the speed of particles or agglomeration of particles, the particles, such as blood particles, being contained in a liquid”) in which another microfluidic channel is positioned between the light source and the light detector (Figure 13 has channels 202 and 204). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have another microfluidic channel positioned between the light source and the light detector, in order to measure the effect of different carrier reagents on the sample.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over NC, and further in view of Kommareddy (United States Patent Application Publication 20110095190).
As to claim 19, NC teaches everything claimed, as applied above in claim 1, with the exception of the channel is in parallel fluid communication with a main flow branch. However, it is known in the art as taught by Kommareddy. Kommareddy teaches the optical analysis of a fluid (paragraph 0005 “The system includes one or more X-ray sources for transmitting X-rays towards a sample and also includes plurality of photon detectors. An array of crystals are arranged in a curvature with appropriate geometry for receiving a plurality of photon energies emitted from the sample and focusing the photon energy on the plurality of detectors.”) where the channel is in parallel fluid communication with a main flow branch (Figure 5, sampling unit 112 takes a portion of the fluid 118, tests it and returns it to the main flow downstream from where it was taken). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the channel be in parallel fluid communication with a main flow branch, in order to monitor the fuel in real time without having to measure all the fuel.
While Kommareddy does not teach a microfluid channel, such is taught by Ness and the teachings of Kommareddy do not dictate the size of the sampling channel. As such, it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to apply the teachings of Kommareddy to the invention of Ness as modified by Coble, in order to limit the sampling size and disruption to the primary flow.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over NC, and further in view of Xie et al (United States Patent Application Publication 20070193373).
As to claim 20, NC teaches everything claimed, as applied above in claim 1, with the exception of the microfluidic channel is at least partially disposed within [a] main flow. However, it is known in the art as taught by Xie. Xie teaches measuring a particle flow (Abstract “sampling, with a sampling probe, a portion of the fluid stream; measuring the flow rate of said sampled portion”) wherein the sampling channel is at least partially disposed within the main flow (Figure 4, paragraph 0014 “sampling probe 20” is similar to applicant’s Figure 11). It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to have the channel is at least partially disposed within the main flow, in order to sample droplets from the most uniform region of the flow (see paragraphs 0056 and 0155).
While Xie does not teach a microfluid channel, such is taught by Ness and the teachings of Xie do not dictate the size of the sampling channel. As such, it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to apply the teachings of Xie to the invention of Ness as modified by Coble, in order to obtain droplets most representative of the flow.
Conclusion
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/J.C.U/Examiner, Art Unit 2877
/MICHELLE M IACOLETTI/Supervisory Patent Examiner, Art Unit 2877
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