DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
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: “a first measurement unit”, “a second measurement 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.
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 10-14 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 14 recites the limitation of “the flow cell”, however there is insufficient antecedent basis for this limitation within the claim. Appropriate correction is required.
Claims 10-13 contain a conditional statement through the use of the term “are executed in response to”. The use of this term renders the claim indefinite, as it is not clear to the examiner whether the limitation following the use of the term is actually performed, or whether it is merely a possibility. The use of the above term imparts uncertainty into the claims because it does not clearly and positively recite the applicant’s invention. Due to the term, the claims recite assumptions and vary degrees of dependence, as well as limitations that may only occur “when” or “if” something else occurs. Appropriate correction is required.
For the purpose of examination, the claims are interpreted in view of the situation wherein the first analysis result does NOT satisfy a predetermined condition, and therefore the second analysis is NOT performed.
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.
Claim(s) 1-7, 10, 13, 15, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 4,573,796 to Martin et al., in view of US Publication 2023/0288312 to You et al.
Regarding claims 1-7, 10, 13, 15-17 and 19-20, Martin discloses and shows in Figure 1, a sample analyzer that analyzes cells in a sample collected from a subject (col. 1, ll. 10-31), comprising:
a first measurement unit (10, 44, 24, 32) configured to interrogate the cells passing through at least one beam spot of a first illumination light (18) to obtain first light information (col. 3, ll. 62 to col. 4, ll. 40; wherein a first light source and modulator illuminate a first spot in a flow cell to generate fluorescence and scattered measurement light);
a second measurement unit (12, 46, 26, 34) configured to interrogate the cells passing through an irradiation area of a second illumination light (50) to obtain second light information (col. 3, ll. 62 to col. 4, ll. 40; wherein a second light source and modulator illuminate a second spot in a flow cell to generate fluorescence and scattered measurement light); and
a controller (30) configured to generate a cell analysis result based on one of (1) a first analysis result based on the first light information, (2) a second analysis result based on the second light information, and (3) the first analysis result and the second analysis result (col. 3, ll. 62 to col. 4, ll. 40; wherein a plurality of detectors obtain a plurality of different measurements which are provided to a data storage and processing means);
[claim 4] wherein the controller is configured to generate the first analysis result by a first analysis method and generate the second analysis result by a second analysis method, and the first analysis method and the second analysis method are different from each other (col. 3, ll. 62 to col. 4, ll. 40; wherein fluorescence and scattered light measurements are obtained);
[claim 5] wherein the controller is configured to generate the cell analysis result by selectively determining a basis of analysis from (1) the first analysis result, (2) the second analysis result, or (3) the first analysis result and the second analysis result (col. 3, ll. 62 to col. 4, ll. 40; wherein fluorescence and scattered light measurements are obtained and combined in a data storage and processing means);
[claim 6] wherein the controller is configured to generate the cell analysis result based on the first analysis result and the second analysis result by complementing the first analysis result with the second analysis result (col. 3, ll. 62 to col. 4, ll. 40; wherein fluorescence and scattered light measurements are obtained and combined in a data storage and processing means);
[claim 7] further comprising a conveyor (16) to convey the sample, wherein the first and second measurement units are configured to interrogate the conveyed sample (col. 3, ll. 62 to col. 4, ll. 40; wherein a sample flow cell channel provides a stream of sample cells);
[claim 10] wherein a measurement of the second light information by the second measurement unit and a generation of the second analysis result by the controller are executed in response to the first analysis result satisfying a predetermined condition, and the controller is configured to generate the cell analysis result based on at least the second analysis result in response to the first analysis result satisfying the predetermined condition (col. 3, ll. 62 to col. 4, ll. 40; wherein a plurality of fluorescence and scattered light measurements are obtained, when a particle arrives a particular point within the sample flow channel (applicant’s predetermined condition));
[claim 13] wherein the controller is configured to generate the cell analysis result based on at least the second analysis result, in response to the first analysis result satisfying a predetermined condition (col. 3, ll. 62 to col. 4, ll. 40; wherein a plurality of fluorescence and scattered light measurements are obtained, when a particle arrives a particular point within the sample flow channel (applicant’s predetermined condition));
[claim 15] further comprising a flow cell (16), wherein the first measurement unit is configured to obtain the first light information of the cells passing through the beam spot in the flow cell, and the second measurement unit is configured to obtain the second light information of the cells passing through the irradiation area in the flow cell (Figure 1);
[claim 17] wherein the first light information includes information of scattered light and information of fluorescence from the cells irradiated with the first illumination light (col. 3, ll. 62 to col. 4, ll. 40; wherein fluorescence and scattered light measurements are obtained and combined in a data storage and processing means);
[claim 19] wherein the controller is configured to control the second measurement unit to flow the cells to pass through the irradiation area of the second illumination light under a fluid condition according to the first analysis result (col. 3, ll. 62 to col. 4, ll. 40; wherein a fluid flow a sample is continuously provided to the plurality of measurement units through a flow cell).
Martin differs from the limitations in that it is silent to the system further comprising,
[claim 1] wherein the second illumination light includes a plurality of distributed lights generated by diffracting a light using a diffractive optical element;
[claim 2] wherein the second measurement unit is configured to obtain the second light information which contains more information of individual cell than the first light information;
[claim 3] wherein the second measurement unit is configured to obtain the second light information which contains more information regarding morphology of individual cell than the first light information;
[claim 16] wherein the second illumination light is a light having a structured illumination pattern;
[claim 20] wherein the controller is configured to generate an image visualizing the cell in the sample based on the second light information.
However, You teaches and shows in Figures 1-2, an imaging flow cytometry system further comprising a beam splitting system (2), which may comprise: a diffractive optical device (10), a spatial light modulator, a DMD or a fiber splitter, for providing “a matrix spot” of a plurality of angularly dispersed beams to a flow cell to excite fluorescence and scattering light, and improving imaging resolution and quality of a stream of sample cells (par. 3, 5, 38-40, 49, 74). You further teaches the imaging flow cytometry system as providing from the matrix spot of illumination light, “a multi-channel fluorescence detection system and a spectral detection system to achieve multi-color flow imaging and spectral flow imaging” (applicant’s more information regarding cell morphology) (par. 64-65, 67).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Martin to include the diffractive optical element discussed above for the advantage of providing a plurality of measurement beams to a flow cell for improving image resolution and quality, with a reasonable expectation of success.
Claim(s) 8-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Martin and You, and further in view of US Publication 2024/0167934 to Nolan et al.
Regarding claims 8-9, Martin discloses and shows a sample analyzer that analyzes cells in a sample collected from a subject (col. 1, ll. 10-31), comprising:
a plurality of light sources (10, 12) with different wavelengths;
a controller (30) configured to generate a cell analysis result based on one of (1) a first analysis result based on the first light information, (2) a second analysis result based on the second light information, and (3) the first analysis result and the second analysis result (col. 3, ll. 62 to col. 4, ll. 40; wherein a plurality of detectors obtain a plurality of different measurements which are provided to a data storage and processing means).
Martin differs from the limitations in that it is silent to the system further comprising: [claim 8] wherein the controller is configured as being capable of controlling operations of the first and second measurement units so that a frequency of measurement by the second measurement unit is lower than a frequency of measurement by the first measurement unit; [claim 9] wherein the controller is configured to control operations of the first and second measurement units so that a frequency of measurement by the second measurement unit is lower than a frequency of measurement by the first measurement unit.
However, Nolan teaches and shows in Figure 1, a flow cytometry system further comprising a plurality of light sources (111-115), each having different wavelengths which are lower than a previous one (par. 39, 53-56).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Martin to include the light sources discussed above for the advantage of providing a plurality of measurement wavelengths to allow characterization of a wider variety of samples, with a reasonable expectation of success.
Regarding claim 14, Martin differs from the limitations in that it is silent to the system further comprising: a first flow cell and a second flow cell, wherein the first measurement unit is configured to obtain the first light information of the cells passing through the beam spot in the flow cell, and the second measurement unit is configured to obtain the second light information of the cells passing through the irradiation area in the flow cell.
However, Nolan teaches and shows in Figure 1, a flow cytometry system further comprising a plurality of light sources (111-115), a plurality of light detection modules (155, 165, 170) and a plurality of flow cell channels (par. 39, 43).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Martin to include the plurality of flow cell channels discussed above for the advantage of providing a plurality of simultaneous sample flows to increase the sample volume throughput and analysis, with a reasonable expectation of success.
Claim(s) 11-12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Martin and You, and further in view of US Publication 2012/0225475 to Wagner et al
Regarding claims 11-12 and 18, Martin differs from the limitations in that it is silent to the system further comprising:
[claim 11] wherein the predetermined condition is satisfied by the first analysis result indicative of a presence of an abnormal cell in the sample;
[claim 12] wherein the predetermined condition is satisfied by the first analysis result representing a number of a certain type of cell being outside a predetermined numerical range;
[claim 18] wherein the controller is configured to generate the first analysis result by grouping cells irradiated with the first illumination light into a plurality of cell populations, and generate the second analysis result by classifying individual cells into cell types.
However, Wagner teaches and shows in Figures 1-2, 8, 12 and 16, a flow cytometry system further comprising a cell sorting system, wherein a variety of individual cells are sorted into populations using “well-known” methods, wherein the population criteria include stem cells, tumor cells, living or dead cells, and chromosome type (par. 17, 126, 128, 133).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Martin to include the cellular sorting limitations discussed above for the advantage of providing high-speed cellular sorting according to predetermined criteria, with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANSEN whose telephone number is (571)270-1736. The examiner can normally be reached Monday to Friday, 8am to 4pm.
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JONATHAN M. HANSEN
Primary Examiner
Art Unit 2877
/JONATHAN M HANSEN/Primary Examiner, Art Unit 2877
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