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 .
Response to Amendment and Status of Application
This notice is in response to the amendments filed 18 March 2026. Claims 63-81 are pending in the instant application where claims 63-66, 69-75, and 79-80 have been amended and claims 1-62 have been cancelled. Applicant’s amendments to the claims have overcome the objections to the drawings, and some but not all rejections under 35 U.S.C. 112(b) set forth in the Non-Final Office Action dated 18 November 2025. The objections and those rejections overcome are hereby withdrawn. Applicant’s amendments have also rendered moot comments made under Claim Interpretation regarding claim 69 and 80 and “the data” – those comments do not appear here in light of the amended claims.
Response to Arguments
Applicant's arguments filed 18 March 2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument (remarks page 3 bottom paragraph – entirety of page 4) that Ness does not disclose all aspects of the independent claims, examiner notes that given the clarifying amendments for “allowing [both] the electromagnetic wave and the polarized electromagnetic wave to irradiate therethrough [the detection wall into detection region]” and subsequently irradiate through a second polarizing sheet, Ness is no longer relied upon to teach all aspects of the claim. The newly added limitations are addressed in the rejection below. Additionally, given the language of the claim, examiner notes that the “electromagnetic wave directly obtained from the electromagnetic source”, though seemingly intended as being unpolarized [i.e. not passing through a polarizing sheet], polarized light sources are well known in the art and an electromagnetic wave directly obtained from the electromagnetic source need not pass through a polarizing sheet to be polarized. If applicant intends for the EM wave obtained directly from the EM source to be unpolarized, this should be made explicit in the claim. However, given the amendments, a rejection under 35 U.S.C. 103 is set forth below.
Applicant’s remarks on page 5 – page 7 paragraph 3 are an explanation of the current invention and are not arguments directed toward any of the references.
In response to applicant's argument (remarks page 8 paragraph 2 and page 9 paragraph 1) that the Ness fails to show certain features of the invention, it is noted that the features upon which applicant relies (i.e. that Ness is a pulse wave and is narrower than the diameter of a particle (droplet) whereas the claimed invention’s EM waves are continuous and cover the diameter of the particle, and that the claimed invention is intended for classifying at least two types or more of particle having different optical properties) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding applicant’s argument within the remarks page 8 paragraph 3, this is a restated argument with regards to only one electromagnetic wave passing through a first polarizing sheet to create a polarized electromagnetic wave and another electromagnetic wave not passing through the first polarizing sheet. This is addressed in the above paragraphs, and is further addressed in the rejection below.
Regarding applicant’s argument (remarks page 9 paragraph 2) that Ness cannot detect particles having different optical properties at the same time and that Ness is unsuitable for detecting particles having large size differences, examiner notes that Ness [0045] discloses that particles investigated in the flow stream may have any suitable diameter relative to the channel, including roughly the same size as the channel or at least half the size of the channel. Thus there is no indication that ness cannot detect particles having large size differences, and there is no indication that particles within Ness tend to not be very different in size, as suggested by applicant.
Regarding applicant’s arguments (remarks starting page 9 “Comparison with Trainer” section), these arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument – the reference Trainer is no longer relied upon in the rejection.
Regarding applicant’s arguments (remarks starting page 11, “Comparison with Michael”) that Michael does not disclose electromagnetic sources producing at least two different wavelengths equipped with a first polarizing sheet… [and remaining limitations from the independent claims], examiner notes that Michael is not relied upon to teach these limitations and is relied upon solely to teach limitations related to the sensing unit and associated collection parameters. Applicant argues that Michael does not classify at least two or more particles having different optical properties, but as first disclosed above in light of In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993), these features are not explicitly claimed.
Regarding applicant’s argument (remarks page 11 paragraph 4) that none of the cited reference disclose or suggest simultaneous irradiation with polarized and non-polarized light from different sources, this is a newly added limitation and is addressed in the rejection below. Examiner also notes that nowhere in the claims does “non-polarized” appear with respect to the electromagnetic wave obtained directly from the electromagnetic source. This needs to be explicitly disclosed for patentable weight to be assigned.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 64, 73, and 81 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.
Regarding claim 64, the claim recites the limitation “the light wave” on line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret the limitation such that any light wave will read on the limitation. “The light wave” appearance on line 4 does not have proper antecedence due to the “or” statement. Examiner also suggests changing “light wave” to “visible light wave” – as best understood from the first wherein clause, essentially all types of light within the EM spectrum are named (infrared, UV, microwave, etc.) except for visible light. This amendment would provide clarity to the claim since “light wave” is be understood by one of ordinary skill as a wave anywhere along the EM spectrum and not just within the visible band.
Regarding claim 73, the claim recites the limitation “the light wave” on line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret the limitation such that any light wave will read on the limitation. As with claim 64, “the light wave” appearance on line 4 does not have proper antecedence due to the “or” statement. Examiner also suggests changing “light wave” to “visible light wave” – as best understood from the first wherein clause, essentially all types of light within the EM spectrum are named (infrared, UV, microwave, etc.) except for visible light. This amendment would provide clarity to the claim since “light wave” is be understood by one of ordinary skill as a wave anywhere along the EM spectrum and not just within the visible band.
Regarding claim 81, the phrases “a suitable ISO” and “a suitable integration time” on line 5 contain a relative term which renders the claim indefinite. The term “suitable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. No degree is given to which characteristics the ISO and integration time must possess to be considered “suitable”. Even though a range is given for each parameter, the claim does not specify that those disclosed ranges are “suitable”, just that the suitable value must lie within the disclosed ranges. Examiner will interpret any ISO and integration time as being “suitable”.
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.
Claims 63-70 and 72-80 are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0194805 A1 by Kevin D. Ness et al. (herein after “Ness”) and further in view of US 2023/0390772 A1 by George Wu et al. (herein after “Wu”).
Regarding claim 63, Ness discloses a device for detecting particles in a fluid (Ness [0034] discloses detection of droplets within a stream of fluid carrying droplets), comprising:
electromagnetic sources producing at least different wavelengths (Ness [0110]-[0112] and fig. 12 show a detection unit comprising an illumination assembly 442 where a blue LED 450 and a cyan LED 452 emit light at 440-520nm and 470-550 nm respectively [sources producing at least two different wavelengths]) and equipped with a first polarizing sheet in a front region of any one of the electromagnetic sources (Ness [0118] discloses a first polarization filter 510 [a first polarizing sheet] which is located downstream from both LEDs [i.e. a front region – “in front of” the LEDs]), an electromagnetic wave directly obtained from the electromagnetic source and a polarized electromagnetic wave irradiating a detection region (Ness fig. 12 shows the LEDs which emit electromagnetic waves; once the waves pass through the polarizing filter 510 it becomes a polarized wave which is incident to a capillary/channel 76 (capillary/channel disclosed in [0111]) the cross section of which is shown in fig. 12; [0101] and fig. 10C discloses the capillary with particles flowing in a direction indicated by the arrows and a shaded region 366 is an illuminated volume [detection region] since beam 364 [having been polarized] illuminates the capillary region; the claim here reads as if only the polarized electromagnetic wave irradiates the detection region which is consistent with Ness),
the detection region provided in the same area with or connected to a container containing a medium fluid required in the detection (Ness fig. 10C shows the illumination volume 366 [detection region]; the detection region is shown within channel 76 which encloses the fluid flowing with droplets within [fluid with suspended droplets considered the medium fluid, required in the detection of droplets]), wherein said detection region has a detection region wall (Ness fig. 10B shows the channel/capillary 76 being made from a cylindrical tube having a thickness – the boundary of the tube is considered the detection region wall), which allows the polarized electromagnetic wave to irradiate therethrough and hit the particles detected in the medium fluid (Ness fig. 10C shows the beam of light 364, having been polarized, passing through the boundary of the channel/capillary 76 to interact with the particles within said channel/capillary 76 [allows the polarized electromagnetic wave to irradiate therethrough]; [0078] discloses light scattering from droplets [i.e. “hit the particles”]), and next to the detection region, a second polarizing sheet and a two-dimensional sensor array provided in sequence, wherein the irradiation of the polarized electromagnetic wave through the second polarizing sheet produces an electromagnetic wave used to irradiate the two-dimensional sensor array (Ness [0118] and fig. 12 disclose a second polarization filter 512 which is downstream from capillary 76 [downstream from the detection region – considered as “next to” since this is not explicitly defined by the claim]; [0022] discloses that fig. 12 is an optical layout for the detection system of fig. 5 – detectors 86 and 88 are shown in the fig and [0047] discloses exemplary detector types as photomultiplier tubes, charge coupled devices, CMOS devices or the like; while fig. 12 and [0115] discloses detectors 484 and 486 as photomultiplier tubes, [0047] makes clear the detectors may be either CCD or CMOS devices, which one of ordinary skill recognizes as being a two-dimensional sensor array, and this is reflected in applicant’s specification page 6 ll. 30-32; [0118] discloses the second polarization filter 512 of fig. 12 as “a collection filter” and the corresponding collection filter 162 of fig. 5 within [0078] is disposed sequentially with detector 86 [second polarizing sheet and two-dimensional sensor array provided in sequence]; [0078] and fig. 5 disclose detected light 168 incident on the detector 86 and is an electromagnetic wave having passed through the second polarization filter 512), said sensor array providing data which is transmitted to a processor (Ness [0061] and fig. 3 shows a controller 126 which controls light sources, fluidics, illumination optics, the detectors 86 and 88, etc. and performs data processing like droplet identification [two-dimensional sensor array provides data to processor]),
the processor provided to analyze the data obtained from the two-dimensional sensor array from a single frame or multiple frames combined to detect the particles and subsequently report the results (Ness fig. 3 above discloses controller 126 functioning as the claimed processor; [0061] discloses that the processor controls generation of detector signals, processes signals for droplet identification, determine whether an identified droplet should be excluded from analysis, estimate one or more target concentrations, etc. [data is analyzed by the processor from the two-dimensional sensor array in either single or multiple frames to detect the particles and report the results; droplet identification, estimating target concentrations, etc. all read on “detecting particles and subsequently reporting the results”]).
Ness is silent to wherein the detection region has a detection region wall which allows the electromagnetic wave and the polarized electromagnetic wave to irradiate therethrough and hit the particles detected in the medium fluid, and wherein the irradiation of the electromagnetic wave and the polarized electromagnetic wave through the second polarizing sheet produces an electromagnetic wave used to irradiate the two-dimensional sensor array.
However, Wu does address this limitation. Ness and Wu are considered to be analogous to the present invention because they are optical systems for particle sensing within fluidic flows.
Wu discloses “wherein the detection region has a detection region wall which allows the electromagnetic wave and the polarized electromagnetic wave to irradiate therethrough and hit the particles detected in the medium fluid, and wherein the irradiation of the electromagnetic wave and the polarized electromagnetic wave through the second polarizing sheet produces an electromagnetic wave used to irradiate the two-dimensional sensor array” (Wu fig. 4C and [0262] discloses a system for providing dual focusing for droplet inspection within a flow channel, where two light sources 227 and 228 provide input light to a polarizing or non-polarizing beamsplitter, where the light from the light sources may be polarized or unpolarized; in the case where the beamsplitter is non-polarizing, one light source generating a polarized beam and the other light source generating unpolarized light are combined within the beamsplitter and are irradiated to a flow channel for dual focusing detection – this demonstrates a flow channel [detection region] allowing both an unpolarized [electromagnetic wave] and polarized [polarized electromagnetic wave] to irradiate therethrough; further, once the beams are through the flow cell, these beams of Wu combined with the system of Ness facilitates the unpolarized and polarized electromagnetic waves passing through the second polarizing sheet of Ness, and producing the second EM wave to irradiate the 2D sensor array).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ness to incorporate wherein the detection region has a detection region wall which allows the electromagnetic wave and the polarized electromagnetic wave to irradiate therethrough and hit the particles detected in the medium fluid, and wherein the irradiation of the electromagnetic wave and the polarized electromagnetic wave through the second polarizing sheet produces an electromagnetic wave used to irradiate the two-dimensional sensor array as suggested by Wu for the advantage of increasing the probability of yielding optical signals of droplet objects with improved signal to noise profiles from the dual beam focusing (Wu [0262]).
Regarding claim 64, Ness when modified by Wu discloses the device for detecting particles in fluid according to claim 63, and Ness further teaches the device wherein
the electromagnetic waves are selected from any one or more of light wave, infrared wave, ultraviolet wave, microwave, X-ray wave, gamma ray, or a combination thereof (Ness [0110]-[0112] discloses the light sources as LEDs – comprising a light wave regardless of wavelength), or
the electromagnetic waves are the light wave having a wavelength ranging from 350-800 nm (see rejection under 35 U.S.C. 112(b) above; Ness [0110]-[0112] discloses the wavelength range for both light sources, the range being between 440-550nm), or
the electromagnetic wave directly obtained from the electromagnetic source is any one of a red-light wave having a wavelength of 620-750 nm, a green-light wave having a wavelength of 500-620 nm, or a blue-light wave having a wavelength of 350-500 nm (Ness [0110]-[0112] discloses light sources as a blue or cyan LED, with a wavelength range between 350-500nm and/or a wavelength range of 500-620nm, or
the polarized electromagnetic wave is any one of a red-light having a wavelength of 620- 750 nm, a green-light wave having a wavelength of 500-620 nm, or a blue-light wave having a wavelength of 350-500 nm (Ness [0110]-[0112] discloses the light source as blue or cyan LED – the wavelength of the light on the far side of the first polarizing sheet 510 is not adjusted and is therefore a blue or cyan light with a wavelength range between 350-500nm and/or wavelength range of 500-620nm as with the preceding limitation), or
the electromagnetic waves from the electromagnetic sources are adjusted to have a suitable wavelength using the electromagnetic waves or the optical composition selected from any one or more of lens, mirror, filter, polarizer, prism, grating, slit, or a combination thereof (Ness fig. 12 and [0118]; the first polarization filter 510 [the first polarizing sheet] “adjusts” the electromagnetic waves via a polarizer, and/or [0114] a slit 476).
Regarding claim 65, Ness when modified by Wu discloses the device for detecting particles in fluid according to claim 63, and Ness further teaches the device wherein the electromagnetic sources produce wavelengths that are at least 10 nm different from one another (Ness [0110]-[0112] discloses blue and cyan LEDs which differ in wavelength by at least 10nm, given their quoted ranges as 440-520nm and 470-550nm which differ at the extremes by 30nm), or
the electromagnetic sources produce wavelengths that are different from one another in a range of 10-1,000 nm (Ness [0110]-[0112] discloses blue and cyan LEDs which differ in wavelength by at least 10nm and within 1,000nm, given their quoted ranges as 440-520nm and 470-550nm), or
the electromagnetic sources produce the electromagnetic wave and the polarized electromagnetic wave that are parallel to one another, the electromagnetic source being selected from any one or more of halogen bulb, light bulb, laser, LED bulb, microwave sources, or a combination thereof (Ness fig. 12 and [0113] disclose that light emitted by the LEDs 450 and 452 [LED bulb] are collimated respectively via lens doubled 454; once combined by Dichroic element 466, the combined beam 470 results in waves that are parallel to one another), or
the electromagnetic sources adjust the electromagnetic wave and the polarized electromagnetic wave such that they are parallel to one another using an optical composition selected from any one or more of lens, mirror, integrator rod, or a combination thereof (not addressed due to the “or” statement), or
a distance from the electromagnetic sources to the detection region is 0-1,000 times greater than a thickness of the detection region to obtain the parallel electromagnetic waves (not addressed due to the “or” statement), or
the electromagnetic sources are 0-30 cm away from the detection region (not addressed due to the “or” statement).
Regarding claim 66, Ness when modified by Wu discloses the device for detecting particles in fluid according to claim 63, and Ness further teaches the device wherein the medium fluid allows the electromagnetic wave and the polarized electromagnetic wave to irradiate therethrough (Ness fig. 10C shows light 364 irradiating through the capillary/channel 76 into a detector 370, and therefore the medium fluid in which droplets are suspended allows the passage of electromagnetic waves), or
the medium fluid contains different types of particles or fluid (Ness [0042] discloses the detection of droplets including detecting characteristics of droplets (i.e. radius, volume), and thus determining the nature of the contents, “whether the droplet contains a target” – given the ability to make these determinations, the medium fluid contains different types of particles since it has the ability to distinguish between them), or
the medium fluid has optical properties selected from any one or more of light absorption, light refraction, light reflection, fluorescence, light scattering, polarization, or a combination thereof (Ness [0042]-[0043] discloses particle detection via absorbance, transmission, reflection, scattering, fluorescence, etc.), or
the medium fluid flows through or stays at rest in the detection region (Ness fig. 10C shows the flow of fluid and droplets within, represented by the large arrows within the capillary/channel 76).
Regarding claim 67, Ness when modified by Wu discloses the device for detecting particles in fluid according to claim 63, and Ness further teaches the device wherein the particles have optical properties selected from any one or more of light absorption, light refraction, light reflection, fluorescence, light scattering, polarization, or a combination thereof (Ness [0042]-[0043] discloses particle detection via absorbance, transmission, reflection, scattering, fluorescence, etc. – the particles have said optical properties in order for the detection of said properties), or
the particles have a size ranging from 1 pm to 5 mm (not addressed due to the “or” statement).
Regarding claim 68, Ness when modified by Wu discloses the device for detecting particles in fluid according to claim 63, and Ness further teaches the device wherein the detection region wall is obtained from any one of transparent material or translucent material or a combination thereof (Ness fig. 10C shows the passage of light through the capillary/channel 76, and the detection region wall is formed from the boundary of the tube; [0049] also discloses the use of the walls of the channel 76 as an optical element, i.e. the wall may function as a cylindrical lens to help focus light – one of ordinary skill recognizes a cylindrical lens as being constructed by transparent or translucent material), or
the detection region wall is obtained from a material with no polarization axis distortion property (not addressed due to the “or” statement).
Regarding claim 69, Ness when modified by Wu discloses the device for detecting particles in fluid according to claim 63, and Ness further teaches the device wherein the two-dimensional sensor array is any one of a complementary metal oxide semiconductor (CMOS) or a charge coupled device (CCD) or a combination thereof (Ness [0047] discloses detector types for detectors 86 and 88 seen in fig. 5 as being charge coupled devices or CMOS devices), or
the two-dimensional sensor array transmits the data regarding any one of shape, size, intensity, wavelength, polarization, or a combination thereof to the processor to detect the particles (Ness [0042]; detection of droplets includes determining characteristics of droplets, including size (radius or volume), shape, etc.), or
the processor is a device capable of analyzing the data, which is selected from any one or more of computer, mobile phone, cloud computing, application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), embedded system, microcontroller, microprocessor, single-board computer, or a combination thereof (Ness [0061] discloses the controller 126 seen in fig. 3 comprising one or more processors (digital processors, centra/computer processing units CPU [computer, microcontroller, microprocessor, etc.]), or
the processor processes and reports the results which are any one or more of types of particles, amount, volume, concentration, optical properties, phase of the particles, or a combination thereof (Ness [0061] controller 126 [processor] provides droplet identification [type of particles], one or more target concentrations [concentration], etc. and optical properties of particles have been disclosed previously within [0042]-[0043]).
Regarding claim 70, Ness when modified by Wu discloses the device for detecting particles in fluid according to claim 63, and Ness further teaches the device further comprising: at least one pump which transmits the medium fluid in a direction from a bottom to a top (Ness [0059] and fig. 3 disclose fluidics 122 which include at least one pump 128 to drive the flow of fluid through the channel [transmits the medium fluid]; regarding “in a direction from the bottom to the top”, the bottom and top are not defined by the claim, and no frame of reference has been established to point out what is intended by “bottom” and “top” – in this case, the “bottom” of the flow is considered as being before the inspection region seen in fig. 10C, and the “top” of the flow is considered as being after the inspection region seen in fig. 10C).
Regarding claim 72, Ness discloses a process for detecting particles (Ness [0034] discloses detection of droplets within a stream of fluid carrying droplets), comprising:
a. providing different types of particles in a medium fluid, which flows through or stays at rest in a detection region (Ness [0042] discloses the detection of droplets including detecting characteristics of droplets (i.e. radius, volume), and thus determining the nature of the contents, “whether the droplet contains a target” – given the ability to make these determinations, the medium fluid contains different types of particles since it has the ability to distinguish between them; fig. 10C and [0101] discloses the capillary with particles flowing in a direction indicated by the arrows and a shaded region 366 is an illuminated volume [detection region]),
b. irradiating an electromagnetic wave directly obtained from an electromagnetic source and a polarized electromagnetic wave having different wavelengths at a detection region through a detection region wall, which allows the polarized electromagnetic wave to irradiate therethrough and hit the particles detected in the medium fluid (Ness fig. 12 [0110]-[0112] discloses two light sources producing two different wavelengths (source 450 is a blue LED and 452 is a cyan LED); [0118] light from the sources is passed through a first polarization filter 510 downstream from the LEDs and passes the then polarized light through capillary/channel 76 [detection region shown in fig. 10C as shaded; fig. 10B shows the channel/capillary 76 being made from a cylindrical tube having a thickness – the boundary of the tube is considered the detection region wall; fig. 10C shows the beam of light 364 passing through the boundary of the channel/capillary 76 to interact with the particles within said channel/capillary 76; [0078] discloses light scattering from droplets [i.e. “hit the particles”]; the claim as written does not necessarily require “the electromagnetic wave obtained directly from an electromagnetic source” to be unpolarized – an electromagnetic source emitting polarized light is within the broadest reasonable interpretation of the claim and polarized EM sources are well known in the art);
c. measuring the polarized electromagnetic wave from an optical interaction of the particles which hits a two-dimensional sensor array (Ness [0022] discloses that fig. 12 is an optical layout for the detection system of fig. 5 – detectors 86 and 88 are shown in the fig and [0047] discloses exemplary detector types as photomultiplier tubes, charge coupled devices, CMOS devices or the like; while fig. 12 and [0115] discloses detectors 484 and 486 as photomultiplier tubes, [0047] makes clear the detectors may be either CCD or CMOS devices, which one of ordinary skill recognizes as being a two-dimensional sensor array, and this is reflected in applicant’s specification page 6 ll. 30-32; [0118] discloses the second polarization filter 512 of fig. 12 as “a collection filter” and the corresponding collection filter 162 of fig. 5 within [0078] is disposed sequentially with detector 86 [second polarizing sheet and two-dimensional sensor array provided in sequence]; [0078] and fig. 5 disclose detected light 168 incident on the detector 86);
d. analyzing data obtained from the two-dimensional sensor array from a single frame of multiple frames combined using a processor and reporting the results (Ness [0061] and fig. 3 shows a controller 126 which controls light sources, fluidics, illumination optics, the detectors 86 and 88, etc. and performs data processing like droplet identification [two-dimensional sensor array provides data to processor]; Ness fig. 3 discloses controller 126 functioning as the claimed processor; [0061] discloses that the processor controls generation of detector signals, processes signals for droplet identification, determine whether an identified droplet should be excluded from analysis, estimate one or more target concentrations, etc. [data is analyzed by the processor from the two-dimensional sensor array in either single or multiple frames to detect the particles and report the results; droplet identification, estimating target concentrations, etc. all read on “detecting particles and reporting the results”]; Ness abstract discloses that data collected may be representative of a first pulse, and also discloses subsequent pulses – i.e. data representative of a single frame of multiple frames is reported).
Ness is silent to irradiating an electromagnetic wave directly obtained from an electromagnetic source and a polarized electromagnetic wave having different wavelengths at a detection region through a detection region wall, which allows the electromagnetic wave and the polarized electromagnetic wave to irradiate therethrough and hit the particles detected in the medium fluid, and measuring the electromagnetic wave and the polarized electromagnetic wave from an optical interaction of the particles which hits a two-dimensional sensor array.
However, Wu does address this limitation. Ness and Wu are considered to be analogous to the present invention because they are optical systems for particle sensing within fluidic flows.
Wu discloses “irradiating an electromagnetic wave directly obtained from an electromagnetic source and a polarized electromagnetic wave having different wavelengths at a detection region through a detection region wall, which allows the electromagnetic wave and the polarized electromagnetic wave to irradiate therethrough and hit the particles detected in the medium fluid, and measuring the electromagnetic wave and the polarized electromagnetic wave from an optical interaction of the particles which hits a two-dimensional sensor array” (Wu fig. 4C and [0262] discloses a system for providing dual focusing for droplet inspection within a flow channel, where two light sources 227 and 228 provide input light to a polarizing or non-polarizing beamsplitter, where the light from the light sources may be polarized or unpolarized; in the case where the beamsplitter is non-polarizing, one light source generating a polarized beam and the other light source generating unpolarized light are combined within the beamsplitter and are irradiated to a flow channel for dual focusing detection – this demonstrates a flow channel [detection region] allowing both an unpolarized [electromagnetic wave] and polarized [polarized electromagnetic wave] to irradiate therethrough; further, once the beams are through the flow cell, these beams of Wu combined with the system of Ness facilitates the unpolarized and polarized electromagnetic waves passing through the second polarizing sheet of Ness, and producing the second EM wave to irradiate the 2D sensor array; examiner reiterates that the claim does not require “the electromagnetic wave obtained directly from an electromagnetic source” to be unpolarized under the broadest reasonable interpretation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ness to incorporate irradiating an electromagnetic wave directly obtained from an electromagnetic source and a polarized electromagnetic wave having different wavelengths at a detection region through a detection region wall, which allows the electromagnetic wave and the polarized electromagnetic wave to irradiate therethrough and hit the particles detected in the medium fluid, and measuring the electromagnetic wave and the polarized electromagnetic wave from an optical interaction of the particles which hits a two-dimensional sensor array as suggested by Wu for the advantage of increasing the probability of yielding optical signals of droplet objects with improved signal to noise profiles from the dual beam focusing (Wu [0262]).
Regarding claim 73, Ness when modified by Wu discloses the process for detecting particles in fluid according to claim 72, and Ness further teaches the process wherein
the electromagnetic wave and the polarized electromagnetic wave are selected from any one or more of light wave, infrared wave, ultraviolet wave, microwave, or a combination thereof (Ness [0110]-[0112] discloses the light sources as LEDs – comprising a light wave), or
the electromagnetic wave and the polarized electromagnetic wave are the light wave having a wavelength ranging from 350-800 nm (see rejection under 35 U.S.C. 112(b) above; Ness [0110]-[0112] discloses the wavelength range for both light sources, the range being between 440-550nm), or
the electromagnetic wave directly obtained from the electromagnetic source is any one of a red-light wave having a wavelength of 620-750 nm, a green-light wave having a wavelength of 500-620 nm, or a blue-light wave having a wavelength of 350-500 nm (Ness [0110]-[0112] discloses light sources as a blue or cyan LED, with a wavelength range between 350-500nm and/or a wavelength range of 500-620nm, or
the polarized electromagnetic wave is any one of a red-light wave having a wavelength of 620- 750 nm, a green-light wave having a wavelength of 500-620 nm, or a blue-light wave having a wavelength of 350-500 nm (see rejection under 35 U.S.C. 112(b) above; Ness [0110]-[0112] discloses the light source as blue or cyan LED – the wavelength of the light on the far side of the first polarizing sheet 510 is not adjusted and is therefore a blue or cyan light with a wavelength range between 350-500nm and/or wavelength range of 500-620nm as with the preceding limitation), or
the electromagnetic wave and the polarized electromagnetic wave from the electromagnetic sources are adjusted to have a predetermined wavelength using the electromagnetic waves or the optical composition selected from any one or more of lens, mirror, filter, polarizer, prism, grating, slit, or a combination thereof (see rejection under 35 U.S.C. 112(b) above; Ness fig. 12 and [0118]; the first polarization filter 510 [the first polarizing sheet] “adjusts” the electromagnetic waves via a polarizer, and/or [0114] a slit 476).
Regarding claim 74, Ness when modified by Wu discloses the process for detecting particles in fluid according to claim 72, and Ness further teaches the process wherein the electromagnetic sources produce wavelengths that are at least 10 nm different from one another (Ness [0110]-[0112] discloses blue and cyan LEDs which differ in wavelength by at least 10nm, given their quoted ranges as 440-520nm and 470-550nm which differ at the extremes by 30nm), or
the electromagnetic sources produce wavelengths that are different from one another in a range of 10-1,000 nm (Ness [0110]-[0112] discloses blue and cyan LEDs which differ in wavelength by at least 10nm and within 1,000nm, given their quoted ranges as 440-520nm and 470-550nm), or
the electromagnetic sources produce the electromagnetic wave and the polarized electromagnetic wave that are parallel to one another, the electromagnetic source being selected from any one or more of laser diode, LED bulb, or a combination thereof (Ness fig. 12 and [0113] disclose that light emitted by the LEDs 450 and 452 [LED bulb] are collimated respectively via lens doubled 454; once combined by Dichroic element 466, the combined beam 470 results in waves that are parallel to one another), or
the electromagnetic sources produce the electromagnetic wave and the polarized electromagnetic wave such that they are parallel to one another using an optical composition selected from any one or more of lens, mirror, integrator rod, or a combination thereof (not addressed due to the “or” statement), or
a distance from the electromagnetic sources to the detection region is 0-1,000 times greater than a thickness of the detection region to obtain the parallel electromagnetic waves (not addressed due to the “or” statement), or
the electromagnetic sources are at least 5 cm away from the detection region (not addressed due to the “or” statement), or
the electromagnetic sources are 0-30 cm away from the detection region (not addressed due to the “or” statement), or
a distance from the electromagnetic sources to the detection region is more than three times greater than a thickness of the detection region to obtain the parallel or nearly parallel electromagnetic waves (not addressed due to the “or” statement).
Regarding claim 75, Ness when modified by Wu discloses the process for detecting particles in fluid according to claim 72, and Ness further teaches the process wherein the medium fluid allows the electromagnetic wave and polarized electromagnetic wave to irradiate therethrough (Ness fig. 10C shows light 364 irradiating through the capillary/channel 76 into a detector 370, and therefore the medium fluid in which droplets are suspended allows the passage of electromagnetic waves), or
the medium fluid contains different types of particles or fluid (Ness [0042] discloses the detection of droplets including detecting characteristics of droplets (i.e. radius, volume), and thus determining the nature of the contents, “whether the droplet contains a target” – given the ability to make these determinations, the medium fluid contains different types of particles since it has the ability to distinguish between them), or
the medium fluid has optical properties selected from any one or more of light absorption, light refraction, light reflection, fluorescence, light scattering, polarization, or a combination thereof (Ness [0042]-[0043] discloses particle detection via absorbance, transmission, reflection, scattering, fluorescence, etc.), or
the medium fluid flows through or stays at rest in the detection region (Ness fig. 10C shows the flow of fluid and droplets within, represented by the large arrows within the capillary/channel 76).
Regarding claim 76, Ness when modified by Wu discloses the process for detecting particles in fluid according to claim 72, and Ness further teaches the process wherein the particles have optical properties selected from any one or more of light absorption, light refraction, light reflection, fluorescence, light scattering, polarization, or a combination thereof (Ness [0042]-[0043] discloses particle detection via absorbance, transmission, reflection, scattering, fluorescence, etc. – the particles have said optical properties in order for the detection of said properties), or
the particles have a size ranging from 1 pm to 5 mm (not addressed due to the “or” statement).
Regarding claim 77, Ness when modified by Wu discloses the process for detecting particles in fluid according to claim 72, and Ness further teaches the process wherein the detection region wall is obtained from any one of transparent material or translucent material or a combination thereof (Ness fig. 10C shows the passage of light through the capillary/channel 76, and the detection region wall is formed from the boundary of the tube; [0049] also discloses the use of the walls of the channel 76 as an optical element, i.e. the wall may function as a cylindrical lens to help focus light – one of ordinary skill recognizes a cylindrical lens as being constructed by transparent or translucent material), or
the detection region wall is obtained from a material with no polarization axis distortion property (not addressed due to the “or” statement).
Regarding claim 78, Ness when modified by Wu discloses the process for detecting particles in fluid according to claim 72, and Ness further teaches the process wherein the two-dimensional sensor array is any one of a complementary metal oxide semiconductor (CMOS) or a charge coupled device (CCD) or a combination thereof (Ness [0047] discloses detector types for detectors 86 and 88 seen in fig. 5 as being charge coupled devices or CMOS devices), or
the two-dimensional sensor array transmits the data regarding any one of shape, size, intensity, wavelength, polarization, or a combination thereof to the processor to detect the particles (Ness [0042]; detection of droplets includes determining characteristics of droplets, including size (radius or volume), shape, etc.), or
the data obtained from the two-dimensional sensor array is the data obtained from the electromagnetic wave (the detector shown in fig. 5 detects an electromagnetic wave, and therefore the data obtained by the two-dimensional sensor array is obtained from the electromagnetic wave), or
the two-dimensional sensor array transmits the data regarding any one of shape, size, intensity, wavelength, polarization, or a combination thereof to the processor to detect the particles (Ness [0061] controller 126 [processor] provides droplet identification [type of particles], one or more target concentrations [concentration], etc. and optical properties of particles have been disclosed previously within [0042]-[0043]).
Regarding claim 79, Ness when modified by Wu discloses the process for detecting particles in fluid according to claim 72, and Ness further teaches the process further comprising: transmitting the medium fluid using at least one pump in a direction from a bottom to a top (Ness [0059] and fig. 3 disclose fluidics 122 which include at least one pump 128 to drive the flow of fluid through the channel [transmits the medium fluid]; regarding “in a direction from the bottom to the top”, the bottom and top are not defined by the claim, and no frame of reference has been established to point out what is intended by “bottom” and “top” – in this case, the “bottom” of the flow is considered as being before the inspection region seen in fig. 10C, and the “top” of the flow is considered as being after the inspection region seen in fig. 10C).
Regarding claim 80, Ness when modified by Wu discloses the process for detecting particles according to claim 72, and Ness further teaches the process wherein the processor is a device capable of analyzing the data, which is selected from any one or more of computer, mobile phone, cloud computing, application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), embedded system, microcontroller, microprocessor, single-board computer, or a combination thereof (Ness [0061] discloses the controller 126 seen in fig. 3 comprising one or more processors (digital processors, centra/computer processing units CPU [computer, microcontroller, microprocessor, etc.])), or
the processor processes and reports the results which are any one or more of types of particle, amount, volume, concentration, optical properties, phase of the particles, or a combination thereof (Ness [0061] controller 126 [processor] provides droplet identification [type of particles], one or more target concentrations [concentration], etc. and optical properties of particles have been disclosed previously within [0042]-[0043]).
Claims 71 and 81 are rejected under 35 U.S.C. 103 as being unpatentable over Ness in view of Wu, and further in view of US 7,471,393 B2 A1 by Michael Trainer (herein after “Michael”). Examiner notes the reference Michael was cited in the IDS filed 06 August 2024 as US 2007/0165225 A1.
Regarding claim 71, Ness when modified by Wu discloses the device for detecting particles in fluid according to claim 63, and Ness further teaches the device further comprising:
a sensor control unit which controls an operation and parameters of the two-dimensional sensor array, [one parameter being] ISO (Ness fig. 3 and [0061] discloses that the controller 126 [sensor control unit] controls the operation of any other components of the system, for examiner the controller controls the sensitivity of each detector by adjusting the gain, creation of signals from detected light, a shuttering function of the optics (affecting the detection ability of the detectors [controls the operation and parameters of the two-dimensional sensor array]; one of ordinary skill in the art would equate adjusting the gain of the detectors with an adjustment of the ISO of the detectors – both effect the brightness of an image),
the sensor control unit controls the operation and the parameters of the two-dimensional sensor array by providing an ISO in a range of 500-5,000,000 (Ness [0061] – the controller 126 is responsible for adjusting the gain of the detectors as desired to achieve a desired result [suitable result] – while gain and ISO have differing units, a suitable gain of the detectors would be equivalent to a suitable ISO; the ISO of a detector is a result effective variable – under MPEP 2144.05 II(A) and II(B) determining the optimum value of a result effective variable requires only routine skill in the art and therefore an optimum value for ISO for the claimed detector may well be within the range of 500-5,000,000) and
the sensor control unit is integrated with the processor or separated from the processor (Ness fig. 3 and [0061] disclose the controller 126 comprising at least a processor – since the controller 126 is disclosed as both the processor and the sensor control unit, and would be integrated with the processor).
Ness when modified by Wu is silent to the device for detecting particles in fluid according to claim 63, wherein the parameters of the two-dimensional sensor array are ISO and integration time, wherein the sensor control unit controls the operation and the parameters of the two-dimensional sensor array by providing an integration time in a range of 10-10,000µs.
However, Michael does address this limitation. Ness, Wu, and Michael are considered to be analogous to the present invention because they are particle detection devices/methods which use optical means to characterize particles within a fluid within a flow cell.
Michael discloses the device for detecting particles in fluid according to claim 63, “wherein the parameters of the two-dimensional sensor array are ISO and integration time, wherein the sensor control unit controls the operation and the parameters of the two-dimensional sensor array by providing an integration time in a range of 10-10,000µs” (Michael col 1 ll. 21-34 discloses a method for obtaining particle parameter distributions, where a suitable integration time is selected as needed by for a detector used to observe the particles; as with the ISO, the integration time of the detector is a result effective variable – under MPEP 2144.05 II(A) and II(B), determining the optimum value of a result effective variable requires only routine skill in the art; therefore, an optimum value for the integration time may be found between the time range of 10-10,000µs, as required by the claim).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ness in view of Wu to incorporate wherein the parameters of the two-dimensional sensor array are ISO and integration time, wherein the sensor control unit controls the operation and the parameters of the two-dimensional sensor array by providing an integration time in a range of 10-10,000µs as suggested by Michael for the advantage of increasing the size range for particles detectable by the device, enabling accurate small particle distributions to be obtainable (Michael col 69 ll. 66 – col 70 ll. 8).
Regarding claim 81, Ness when modified by Wu discloses the process for detecting particles in fluid according to claim 72, and Ness further teaches the process further comprising: controlling, by a sensor control unit, operation and parameters of the two-dimensional sensor array [one parameter being] ISO (Ness fig. 3 and [0061] discloses that the controller 126 [sensor control unit] controls the operation of any other components of the system, for examiner the controller controls the sensitivity of each detector by adjusting the gain, creation of signals from detected light, a shuttering function of the optics (affecting the detection ability of the detectors [controls the operation and parameters of the two-dimensional sensor array]; one of ordinary skill in the art would equate adjusting the gain of the detectors with an adjustment of the ISO of the detectors – both effect the brightness of an image), wherein
the sensor control unit controls the operation and the parameters of the two-dimensional sensor array by providing a suitable ISO in a range of 500-5,000,000 (see rejection under 35 U.S.C. 112(b) above; Ness [0061] – the controller 126 is responsible for adjusting the gain of the detectors as desired to achieve a desired result [suitable result] – while gain and ISO have differing units, a suitable gain of the detectors would be equivalent to a suitable ISO; the ISO of a detector is a result effective variable – under MPEP 2144.05 II(A) and II(B) determining the optimum value of a result effective variable requires only routine skill in the art and therefore an optimum value for ISO for the claimed detector may well be within the range of 500-5,000,000), and
the sensor control unit is integrated with the processor or separated from the processor (Ness fig. 3 and [0061] disclose the controller 126 comprising at least a processor – since the controller 126 is disclosed as both the processor and the sensor control unit, and would be integrated with the processor).
Ness when modified by Wu is silent to the process for detecting particles in fluid according to claim 72, wherein the parameters of the two-dimensional sensor array are ISO and integration time, wherein the sensor control unit controls the operation and the parameters of the two-dimensional sensor array by providing a suitable integration time in a range of 10-10,000µs.
However, Michael does address this limitation. Ness, Wu, and Michael are considered to be analogous to the present invention because they are particle detection devices/methods which use optical means to characterize particles within a fluid within a flow cell.
Michael discloses the process for detecting particles in fluid according to claim 72, “wherein the parameters of the two-dimensional sensor array are ISO and integration time, wherein the sensor control unit controls the operation and the parameters of the two-dimensional sensor array by providing a suitable integration time in a range of 10-10,000µs” (see rejection under 35 U.S.C. 112(b) above; Michael col 1 ll. 21-34 discloses a method for obtaining particle parameter distributions, where a suitable integration time is selected as needed by for a detector used to observe the particles; as with the ISO, the integration time of the detector is a result effective variable – under MPEP 2144.05 II(A) and II(B), determining the optimum value of a result effective variable requires only routine skill in the art; therefore, an optimum value for the integration time may be found between the time range of 10-10,000µs, as required by the claim).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ness in view of Wu to incorporate wherein the parameter of the two-dimensional sensor array is an integration time, wherein the sensor control unit controls the operation and the parameters of the two-dimensional sensor array by providing a suitable integration time in a range of 10-10,000µs as suggested by Michael for the advantage of increasing the size range for particles detectable by the device, enabling accurate small particle distributions to be obtainable (Michael col 69 ll. 66 – col 70 ll. 8).
Documents Considered but not Relied Upon
The following document(s) were considered but not relied up on for the rejection set forth in this action:
US 2010/00220315 A1 by Michael M. Morrell et al.
US 2006/0256335 A1 by Yong Qin Chen
US 5,760,900 A by Yuji Ito et al.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOSHUA M CARLSON/Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877
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