Response to Arguments
Applicant’s arguments, filed 08/04/26, with respect to the rejection(s) of claim(s) under 35 USC 103 as unpatentable over Minemura in view of Jureller have been considered but are not fully persuasive. As described below, the limitation upon which the argument stands is unclear if it is positively limiting on the claimed method and device or merely description of optimal conditions. Until the rejections under 35 USC 112 are resolved, only a loose application of prior art can be performed without knowing the exact metes and bounds of the claim limitations.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: scanning unit and calculation unit in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification describes the corresponding structure as:
Scanning unit = Z axis drive mechanism, variable focus lens, XYZ axis drive mechanism, scanning mechanism, and equivalents (Figure 8, 15-17)
Calculation unit = signal processing unit implemented as circuitry and/or CPU executing software (Figure 8)
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 claim 1 and 9, the limitation “light following a movement …respectively different positions in the optical axis direction of the particle” is indefinite since it is unclear what structural or operational requirement is imposed on the scanning unit. In particular, it is unclear what is meant by “the light following movement of the particle.” Does the claim require a particular relationship between scan rate and particle motion, optical tracking of a particle, or some other condition. Additionally, the phrase “reflected from respectively different positions in the optical axis direction of the particle is unclear if it refers to different positions along the optical axis or different positions of the particle, or both. Clarification is required.
With respect to claim1 and 9, the limitation “the plurality of focal point positions” lacks antecedent basis. Claim 1 previously introduces scanning of “a focal point position” but does not positively recite that the scanning unit scants to, or that the detector detects at “a plurality of a focal point positions.” Correction is required.
With respect to claim 1 and 9, the limitation “the image acquired by imaging the particle” lacks antecedent basis. No previous step disclosed imaging the particles. Images of the particles are only disclosed with respect to the calculating steps but the actual step of imaging or the structure for imaging is not supported. Correction is required.
With respect to claim 1 and 9, the switching logic is unclear. Claim 1 discloses that when the ratio is less than the switching threshold value, calculating the size with the maximum detected intensity. If the ratio is equal to or greater than the switching threshold value, calculate the size using an image. If that size determined by the image is equal to or less than the switching threshold, use the size previously calculated using the maximum detected intensity. The switching algorithm is not clear and consistent. Among other things, it is unclear if a single “switching threshold value” is compared to both the dimensionless ratio (size/spot diameter) and to an absolute particle size from the image (different types of dimensions) and how that comparison can be performed if the variables are not aligned. Additionally, then the image based size is equal to or less than the switching threshold, the claim requires reverting to the previously calculated maximum intensity size, but that size is what resulted in switching to the image based method instead of the intensity based method, so this creates an endless loop between the two branches. Clarification is required.
With respect to claim 1 and 9, the limitation discloses the frame rate is essentially higher than Brownian motion speed of the particle. Frame rate and Brownian motion speed are not like dimensions and cannot be directly compared (Frame rate is frames per second while Brownian motion speed is length per time). The claim requires comparing quantities of incompatible units. Clarification is required.
With respect to claim 1 and 9, the relationship among frame rate formula, numerical frame rate examples and detection rate is confusing. It is unclear the metes and bounds of the claim for infringement purposes. Whther the scanning unit must operate at a frame rate equal to (γ x D) / (Δz x Δd), at least that value but could be higher, or something else. The language “at the frame rate …” is ambiguous relative to the specifications FR>… relationships described. Additionally, the phrase “detection rate becomes one” is unclear, whether detection means a measured detection rate, a simulated detection success rate as in the specification, a normalized quantity) and whether ri tis required for operating the device or merely descriptive of intentions. The numerical frame rate / particle size conditions are additionally unclear as whether they are also positively recited as mandatory or are simply describing optimal operating conditions, conditions under which the detection rate becomes one (which is still not clear if it is required), or limitations that must be simultaneously satisfied alongside the formula (γ x D) / (Δz x Δd). Finally, it is not disclosed how γ is determined so as to define the scope of the claim. The specification discloses fitting values and algorithm conditions needed for high success rates, but does not define a required term or conditions for γ.
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 2017/0160185.
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)
Minemura fails to expressly disclose the mathematical frame rate condition FR > (γ x D) / (Δz x Δd) or the specified numeral frame rate vs particle size and “detection rate becomes one” examples recited in the amendments.
However, Minemura already confronts the problem that Brownian motion complicates axial focus stepping and maximum extraction and teaches tracking and maximum extraction as the solution. A person of ordinary skill in the art at the time of filing, seeking to ensure that z-scanning is fast enough relative to diffusion that the same particle is not spuriously treated as multiple particles at different z positions would have found it obvious to selecte a sufficiently high axial sampling frame rate relative to the particle’s behavior, Δz and Δd. Choosing a frame one on the order of about tens to 100 frames per second for submicron to micron particles in liquid is consistent with known high speed optical sampling of Brownian particles. Expressing that design requirement in the proportional format of (γ x D) / (Δz x Δd) is an obvious formulation of the same engineering constraint described by Minemura’ s embodiment 4. The constant γ is a generic routine fitting that optimizes parameters.
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 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 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 in view of Yu et al. U.S. Patent #10,598,609.
With respect to claims 16 and 17, Minemura 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
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/REBECCA C BRYANT/ Primary Examiner, Art Unit 2877
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