Response to Arguments
Applicant’s arguments, filed 09/22/2025, with respect to the rejection(s) of claim(s) under 35 USC 103 as unpatentable over Minemura in view of Jureller have been considered and are amended to include the new limitation. The amendment is successful in overcoming the previous rejection under 35 USC 112 however raises a new issue described below.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 9 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.
With respect to claims 1 and 9, the limitation “the frame rate is higher than a Brownian motion speed of the particle to prevent reflected light from the…” is indefinite. If a claim is amendable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention. (Ex parte Miyazaki 89 USPQ.2d) In this case, as in Miyazaki, the claim structure is dependent upon elements not defined within the claim apparatus (for Miyazaki, it was based on a user height). The frame rate is dependent upon a Brownian motion speed of a particle, a variable that is defined by many elements, not limited to the fluid itself and the particle, both of which are not part of the claimed structure. Correction is required.
The balance of claims is likewise rejected for failing to correct the deficiencies of claims upon which they depend.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Minemura et al. U.S. Publication 2017/01600185 in view of Jureller et al. U.S. Patent #7,990,524.
With respect to claim 1, 9, Minemura discloses an optical measurement method comprising:
A light source configured to emit light (Figure 22, light source 501, P.0117)
A scanning unit configured to acquire a plurality of XY plane image of the particle by scanning a plurality of focal point positions of the light along an optical axis direction of the light (P.0004, P.0117, Figure 10, S101)
A detector configured to detect an intensity of the light reflected from the sample at each plurality of focal point positions (Figure 22, detector 520, P.0120)
A calculation unit configured to calculate a size of the particle by obtaining a corresponding specified particle size by plotting a correspondence relationship of particle size and a maximum detected intensity of light reflected from the sample (P.0121, Figure 17, P.0101, P.0114)
Wherein the scanning unit is further configured to scan the focal point position of the light so that the light following a movement of the particle in the optical axis direction is reflected from respectively different positions in the optical axis direction of the particle in a state where the particle moves in the optical axis direction in the sample (Figure 12, P.0082)
The calculation unit is further configured to perform the calculating of the size of the particle by using the maximum detected intensity of the light reflected from the sample from among the intensities of the light detected at each of the plurality of focal point position of the light along the optical axis direction (P.0099, P.0104-0105)
The calculation unit is further configured to switch between calculating the size of the particle using the maximum light intensity and calculating the size of the particle using an image acquired by imaging the particles by comparing a threshold value for switching with a value obtained by dividing the particle size calculated by using the maximum light intensity by a spot diameter of the light (P.0100, P.0094, Figure 7, S103/104, P.0099, wherein switching occurs when the cell size is greater than or less than two or three times larger than the optical spot size, P.0133, switching = “by replacing the two dimensional data Image(x,y) acquired by this method with the data acquired in such as step S101…))
When a value obtained by dividing the particle size calculated by using the maximum light intensity by a spot diameter of the light is less than the switching threshold value, the calculation unit is configured to calculate the size of the particle by using the maximum detected intensity of the light reflected from the sample from among the intensities of the light detected at each focal point position of the light along the optical axis direction (P.0099, P.0104-105, P.0133)
When the value obtained by dividing the particle size calculated by using the maximum light intensity of a spot diameter of the light is equal to or greater than a first switching threshold value, the calculation unit is further configured to calculate the size of the particle again by using the image acquired by imaging the particle (P.0100, first switching threshold =optical spot size, image = half width of detection signal intensity)
When the size of the particle calculated by using the image is equal to or less than a second switching threshold value, the calculation unit is further configured to use the size of the particle previously calculated by using the maximum detected light intensity reflected from the sample from among the intensities of the light detected at each focal point position of the light along the optical axis direction (P.0100, second switching threshold =optical spot size, image = half width of detection signal intensity, P.0093)
Wherein in the scanning step, when a scanning interval of the light in the optical axis direction is defined as Δd, a resolution of the size distribution measurement method in the optical axis direction is defined as Δz, a diffusion coefficient of the particle is defined as D, and the number of scans per second of the focal point position of the light in the optical axis direction is defined as a frame rate, the focal point position is scanned at the frame rate of (կ x D)/ (Δz x Δd) (For any constant կ, this would be the mathematical basic formula for determining frame rate based on a particular resolution and size of particles)
However, Minemura fails to disclose the frame rate is 10 frames per second (fps) or higher and the frame rate is higher than a Brownian motion speed of the particle.
Jureller discloses a scanning apparatus using multiphoton multifocal source comprising:
A light source configured to emit light (Figure 1, laser 102)
A scanning unit configured to acquire a plurality of XY plane images of the particle by scanning each of a plurality of focal point positions of the light along an optical axis direction of the light (Figure 1, Galvo mirror 104, Col.6, l17-21, l 27-31)
A detector configured to detect an intensity of the light reflected from the sample at each of said plurality of focal point positions (Col.6, l 1-11, Col.7, l 46-49)
Where in the frame rate is 10 frames per second or higher by using an acousto-optic modulator or a Galvano mirror as the scanning unit (Col.5, l 14-18, l 31-34)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the Galvano mirror scanner of Jureller with the higher frame per second scan rate for the optical measurement of Minemura since the higher scan rate of Jureller allows more uniform coverage over an entire sample and no “blinking” of objects frame to frame yet still maintaining lower costs with less expensive equipment (Col.4, l 2-11).
Additionally, it should be noted that the limitation “the frame rate is higher than a Brownian motion speed of the particle” cannot be limiting on the apparatus since the Brownian motion speed of the particle is a variable number defined by many factors outside the structure of the device. The Brownian motion speed of a particle is in part defined by the particles themselves and cannot be used as reference for the apparatus. Arguendo, that the frame rate were limited by the Brownian motion of the particle, one of ordinary skill in the art would enable the frame rate to be of a speed such that particles are not double detected in order to have a more accurate particle count. Selecting an appropriate frame rate based on the result effective variables of the flow and particles would be within ordinary skill.
With respect to claim 2, 3, 7, 8, Minemura in view of Jureller discloses all of the limitations as applied to claim 1. In addition, Minemura discloses:
2- Wherein the scanning unit scans the focal point position of the light in a plane orthogonal to the optical axis direction for each focal point position of the light along the optical axis direction (P.0050, P.0135-P.0137)
2- The calculation unit specifies the number of particles on the plane by determining whether or not the particle exists in a coordinate region within a predetermined range on the plane according to the intensity of the light (P.0066, Figure 14)
3- Wherein the calculation unit continuously samples the intensity of the light along the optical axis direction in the coordinate region (Figure 21, N-th acquisition implies repeated measurements, “track observed cell” requires continuous observation, P.0125)
3- The calculation unit determines that the particle exists in the coordinate region when the continuously sampled intensity is continuous for the first time or more along the optical axis direction and is equal to or greater than a determination threshold value (P.0079)
7- An optical branching portion that branches the light emitted by the light source and generates measurement light and reference light and an interference optical system that generates a plurality of interference lights having phase relationships different from each other by multiplexing signal light generated by the reflection of the measurement light from the sample with the reference light (P.0117)
7- Wherein the detector detects the interference light and outputs the detected interference light as an electric signal (P.0117-121)
8-The calculation unit outputs data describing the number of size distributions each associated with one of said plurality of detected particles (Figure 18, step S187)
With respect to claim 6, Minemura in view of Jureller discloses all of the limitations as applied to claim 1 above. In addition, Minemura discloses:
6-When the calculation unit calculates the size of the particle by using correspondence relationship data that describes a correspondence relationship between the intensity of the light reflected from the sample and the size of the particle (P.0015, P.0101, Claim 1)
However, Minemura fails to disclose the correspondence relationship data describes the correspondence relationship for each type of sample.
Minemura discloses a correspondence relationship for different sizes of particles and it would be obvious to one of ordinary skill in the art that different types of particles react with different signal intensities so therefore require different correspondence relationships. Providing correspondence relationships for different types of samples will allow a greater variety of samples to be more accurately measured.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Minemura et al. U.S. Publication 2017/0160185 in view of Jureller U.S. Patent #7,990,524 and further in view of in view of Yu et al. U.S. Patent #10,598,609.
With respect to claims 16 and 17, Minemura in view of Jureller discloses all of the limitations as applied to claims 1 and 9 above. However, Minemura fails to disclose regarding the sample container.
Yu discloses a universal sample holding device comprising:
The sample is stored in a sample container comprising a storage hole for storing the sample and a gas discharge portion that releases gas contained in the sample stored in the storage hole (Figure 1a, 1c, storage hole = sample chamber 3, gas discharge portion = holes 12)
Wherein a bottom surface of the storage hole is sealed with a transmissive substrate that transmits light (Figure 1c, windows 10, Col.4, l 7-21)
Wherein the gas discharge portion is formed of a gap portion protruding from an inner wall of the storage hole with respect to a base material of the sample container (Col.4, l 29-31)
Wherein one or two of the gap portions are formed on the inner wall of the storage hole (Figure 1c)
Wherein the gap portion is connected to the storage hole at least at a bottom portion of the storage hole (Col.4, l 36-38)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the sample storage container of Yu for the measurement device of Minemura since the sample of Minemura is necessarily contained within something and Minemura is silent on the issue. The sample container of Yu provides the benefit of allowing multimodal analyses of samples with a low fabrication cost (Col.2, l 4-9).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA CAROLE BRYANT whose telephone number is (571)272-9787. The examiner can normally be reached M-F, 12-4 pm.
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/REBECCA C BRYANT/ Primary Examiner, Art Unit 2877