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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7 November 2024 and 27 October 2025 is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an 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:
“an irradiation unit that irradiates…” in claim 1;
“a detection unit that detects…” in claims 1, 17, 18 and 19;
“a generation unit that corrects…” in claims 1 and 17;
“an evaluation unit that evaluates…” in claims 1 and 17; and
“a processing unit that generates…” in claims 1 and 17.
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 corresponding structure described in the specification is as follows:
For the irradiation unit: Figures 1-2, 101 is an irradiation unit comprising light source unit 111 and light guide optical system 112, see paragraph [0024].
For the detection unit: Figures 1-2, 102 is a detection unit comprising a detection optical system 121, EVS 122, event data processing unit 123 and speed measurement unit 124, see paragraphs [0025], [0027] and [0028]. See also Figure 10.
For the generation unit: There is no specific structure specified in the specification for the claimed generation unit. The term “generation unit” is only used in the summaries and is not used in the detailed disclosure. Paragraph [0068] in the specification is the only paragraph which talks about the function claimed of correcting time, however, no structure is disclosed in this section.
For the evaluation unit: There is no specific structure specified in the specification for the claimed generation unit. Figure 10 shows an “evaluation unit” 12, however, only as a generic box, and paragraph [0079] explains about the evaluation unit, however, does not provide any details about the specific structure.
For the processing unit: Figure 1 shows an information processing unit 103 described in paragraph [0033] to be a generic processor, however, the specification odes not provide explanation as to 103 performing the function claimed. Paragraph [0080] explains there is a selection unit 13 that selects the image data with a highest evaluation, and then paragraph [0084] explains that a reconstruction unit 15 [also referred to as a processing unit] that “reconstructs the image data…for each pixel…” however, since multiple processors are disclosed with no clear connection to the function claimed, it is unclear which processing unit in the specification is associated with the claimed function. Further, whichever disclosed “processing unit” is the specific structure, since the specification only discloses generic processors, the limitation would be a computer-implemented means-plus-function limitation, which requires an algorithm [See MPEP § 2181], and there is not specific algorithm for the claimed processing unit to perform the claimed function.
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 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 1-17 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 limitations “a generation unit that corrects…”, “an evaluation unit that evaluates…” and “a processing unit that generates…” in claims 1 and 17 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Regarding the generation unit, the disclosure is devoid of any structure that performs the function in the claim. The term “generation unit” is only used in the summaries and is not used in the detailed disclosure. Paragraph [0068] in the specification is the only paragraph which talks about the function claimed of correcting time, however, no structure is disclosed in this section.
Regarding the evaluation unit, the disclosure is devoid of any structure that performs the function in the claim. Figure 10 shows an “evaluation unit” 12, however, only as a generic box, and paragraph [0079] explains about the evaluation unit, however, does not provide any details about the specific structure.
Regarding the processing unit, no association between the structure and the function can be found in the specification. Figure 1 shows an information processing unit 103 described in paragraph [0033] to be a generic processor, however, the specification does not provide explanation as to 103 performing the function claimed. Paragraph [0080] explains there is a selection unit 13 that selects the image data with a highest evaluation, and then paragraph [0084] explains that a reconstruction unit 15 [also referred to as a processing unit] that “reconstructs the image data…for each pixel…” however, since multiple processors are disclosed with no clear connection to the function claimed, it is unclear which processing unit in the specification is associated with the claimed function. Further, whichever disclosed “processing unit” is the specific structure, since the specification only discloses generic processors, the limitation would be a computer-implemented means-plus-function limitation, which requires an algorithm [See MPEP § 2181], and there is not specific algorithm for the claimed processing unit to perform the claimed function.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-16 are rejected due to their dependency from claim 1.
Allowable Subject Matter
Claims 1-17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 18-19 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
In the closest prior art:
Howell et al. (High-speed particle detection and tracking in microfluidic devices using event-based sensing) disclose generally:
irradiating a particle with light (Figure 2A);
detecting a luminance change of light emitted from the particle by the irradiation with the light (Figure 2A and Figure 1);
outputting event data including information of a time when the event is detected (See the section Event-data collection and pre-processing, first paragraph.);
aligning the information of the time of some of the pieces of event data (Figures 7-8);
generating particle information regarding the particle based on the event data (Figure 7 and see the section Materials and methods, the subsection Imaging setup, third paragraph.).
Howell et al. fail to teach of the particle being a bioparticle, and further that the aligning comprises correcting as claimed, and further fails to teach of the claimed evaluating and using the highest evaluation when generating bioparticle information.
Borowski (US 2013/0300838) [cited by applicant] generally discloses methods and devices for generating a representation of at least one object in a 3D scene in the real word.
Nishihara et al. (US 2018/0328783) [cited by applicant] relates to an optical pulse detection device, an optical pulse detection method, a radiation counter device, and a biological testing device. Nishihara et al. more specifically disclose an optical pulse detection device includes a pixel array unit in which a plurality of pixels are arranged in a two-dimensional lattice shape, an AD converter that converts output signals of each of the pixels in the pixel array unit into digital values with gradation greater than 1 bit, and a control circuit that performs error determination processing of comparing the digital value with a predetermined threshold value, and discarding a digital value, which is greater than the threshold value, among the digital values as an error, and the method includes : converting output signals of each of the pixels in the pixel array unit into digital values with gradation greater than 1 bit; and performing error determination processing of comparing the digital value with the predetermined threshold value, and discarding a digital value, which is greater than the threshold value, among the digital values as an error.
Basiji et al. (US 6,211,955) [cited by applicant] generally relates to imaging moving objects or particles for purposes of analysis and detection, and more specifically, to a system and method for determining and analyzing the morphology of moving objects, such as cells, and for detecting the presence and composition of Fluorescence In-Situ Hybridization (FISH) probes within cells.
Kim et al. (US 2017/0033777) [cited by applicant] disclose a threshold voltage control method including receiving noise event signals from a sensing core, the sensing core sensing a portion of a moving object, and generating an event signal. The threshold voltage control method further includes determining a type of the noise event signals, determining a number of the noise event signals based on the type of the noise event signals, determining whether the number of the noise event signals satisfies a condition, and controlling a threshold voltage value corresponding to the noise event signals in response to the determining that the number of the noise event signals does not satisfy the condition.
Takatsuka et al. (WO 2021/215173 A1) [cited by applicant] disclose a measuring device for performing measurement based on an image taken on an object contained in a fluid, such as plankton contained in water, and a technical field of an imaging control method thereof.
Furukawa et al. (WO 2022107557 A1/US 2023/0417671) disclose a biological sample analysis system according to an embodiment comprises: an emission unit (101) that emits light onto biological particles in a biological sample; a detection unit (102) comprising a plurality of pixels that each detect, as an event, brightness variation in the light radiated from the biological particles as a result of the light emission; and a processing unit (103) for using the events detected by the pixels to generate biological particle information relating to the biological particles.
Furukawa et al. fail to teach of the claimed correcting of the time and of the evaluating and using the highest evaluation when generating bioparticle information.
Tahara (WO 2023276269 A1/US 2024/0280468) discloses a biological sample analyzer shown in FIG. 1 includes a light irradiation unit that irradiates light onto the biological sample flowing through the flow channel, and a detection unit that detects light generated by irradiating the biological sample with light, and an information processing unit that processes information about the light detected by the detection unit.
Tahara fails to teach of the claimed correcting of the time and of the evaluating and using the highest evaluation when generating bioparticle information.
Tahara (WO 2022270009 A1/US 2024/0219305) discloses a biological sample analyzer including a light irradiation unit that irradiates a biological particle contained in a biological sample with light; a detection unit that detects light generated by the light irradiation; and an information processing unit that controls the light irradiation unit, in which the information processing unit determines whether a detection result of fluorescence by the detection unit satisfies a predetermined condition, and adjusts an output of light irradiation by the light irradiation unit according to the determination result.
Tahara fails to teach of the claimed correcting of the time and of the evaluating and using the highest evaluation when generating bioparticle information.
Therefore, even in a combination, the closest prior art fails to teach and/or suggest at least “correcting…information of a time of some of a plurality of pieces of event data…” and “generating bioparticle information regarding the bioparticle based on image data with a highest evaluation among the plurality of pieces of image data” in the combination with the other recited features.
Conclusion
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/STEPHEN G SHERMAN/Primary Examiner, Art Unit 2621
15 July 2026
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