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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 5-10 in the reply filed on 04/10/2026 is acknowledged. Therefore, claims 1-4 are withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 5-7 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019142590A1-Hirano (hereinafter “Hirano”, all citations are made to the machine English translation).
Regarding claim 5, Hirano discloses a living cell counting device (the
present invention relates to a cell test apparatus, a cell test method, a program, and a recording medium, page 1, paragraph 1, line 1; an inspection apparatus capable of realizing viable cell count estimation, page 1, paragraph 6, lines 1-2) comprising: a turbidity sensor (sensor 20 measures the living cell density and the living cells in the culture solution, page 10, paragraph 7, lines 5-6) configured to measure an amount of suspensoids contained in a cell suspension;
Hirano discloses a measuring instrument (cell inspection system 1 performs principal component analysis or the like on the capacitance, page 10, paragraph 7, lines 4-6) configured to measure capacitance of the cell suspension which varies depending on whether cells are living or dead;
Hirano discloses a calculation unit (calculation unit 26—the information representing the estimated viable cell number output from the calculation unit 26 includes the elapsed time from the start of the culture; calculation unit 26 the estimation result of the number of cells based on the information indicating the estimated number of living cells output, page 4, paragraph 4, lines 16-20) configured to calculate one or more of the number of living cells, the number of dead cells, and a survival rate of cells that are contained in the cell suspension, based on the capacitance per unit of living cells, the capacitance per unit of dead cells, the amount of the suspensoids, and the capacitance of the cell suspension.
Regarding claim 6, Hirano discloses a storage unit configured to store data of the capacitance per unit of living cells and the capacitance per unit of dead cells (storage unit 27 is connected to the calculation unit 26, page 3, paragraph 3, lines 2-3; the storage unit 27 stores cell names, set values of culture conditions, and the like. The storage unit 27 stores measurement values, viable cell density, elapsed time, and the like in the learning operation mode; page 5, paragraph 3, lines 1-2).
Regarding claim 7, Hirano discloses wherein the capacitance of the cell suspension is used for calculation after background capacitance of substances other than cells is removed (the estimation unit 262 determines whether the capacitance belongs to the first phase, the second phase,..., the n-th phase, page 8, paragraph 10, lines 1-2).
Regarding claim 10, Hirano discloses wherein examples of a method for measuring the amount of the suspensoids include a transmitted light measurement method, a scattered light measurement method, a transmitted light and scattered light comparison method, an integrating sphere method, or a particle count method (cell counter 4 outputs information indicating the measured viable cell density to the cell inspection apparatus, page 3, paragraph 5, lines 5-6).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019142590A1-Hirano (hereinafter “Hirano”, all citations are made to the machine English translation) as applied to claim 7 above, and further in view of US 5,182,193A-Mishima et al (hereinafter “Mishima”).
Regarding claim 8, Hirano teaches the invention discussed above in claim 8. Further, Hirano teaches a measuring instrument (sensor unit 22, where unit 22 measures the value output from the probe 21 into two of a capacitance (dielectric constant) and a dielectric conductance (conductivity) by a known method, and outputs the separated capacitance, page 4, paragraph 2, lines 1-3). However, Hirano does not explicitly teach a cell separation device.
For claim 8, Mishima teaches an invention relating to a method and device for measuring biomass (col. 2, lines 30-32) and Mishima teaches culture collected by centrifugal separation (col. 4, lines 58-59), which reads on the instant claim limitation of a cell separation device.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Hirano and further include a cell separation device as taught by Mishima, because Mishima teaches the culture sample undergoes washing with water and centrifugal precipitation in order to remove soluble matters and floating matters such as broken pieces of bacteria (col. 7, lines 29-32).
Regarding claim 9, Hirano teaches the invention discussed above in claim 8. However, Hirano does not explicitly teach a method for separating cells.
For claim 9, Mishima teaches an invention relating to a method and device for measuring biomass (col. 2, lines 30-32) and Mishima teaches culture collected by centrifugal separation (col. 4, lines 58-59), which reads on the instant claim limitation of a method for separating cells.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Hirano and further include a method for separating cells as taught by Mishima, because Mishima teaches the culture sample undergoes washing with water and centrifugal precipitation in order to remove soluble matters and floating matters such as broken pieces of bacteria (col. 7, lines 29-32).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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