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
Claims 10-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/27/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 1-9 and 15-20 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 1 recites “the particle that passes through the first spot” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “the particle that passes through the second spot” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “the image of the particle” in lines 18-19. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “the delay time to arrival of the particle at the sorting section” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “the detection position” in line 2 and “the second particle detection section” in line 3. There is insufficient antecedent basis for these limitations in the claim.
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 1, 3-9, 17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being by Nitta et al. (“Intelligent Image-Activated Cell Sorting,” Cell 175, 266–276, September 20, 2018) (cited by applicant.
Nitta et al. teaches an FDM image acquisition technique that employs a linear array of multiple intensity-modulated excitation beams with distinct modulation frequencies. The beam array is focused across the microchannel to produce a linear array of focal spots in the direction perpendicular to the flow. (page 268, left-hand column)
The beam is provided by a laser. (page 276.e3 “Principles of the FDM microscope”)
A first imaging unit ( FDM microscope ) images at lease a first spot and a second imaging unit (CMOS camera) images at least a second spot.
A first detector ( Speed meter OI1 ) detects the particles passing through at least the first spot, a second detector ( Speed meter Ol4 ) detects the particles passing through at least the second spot.
A sort determination unit (Image analysis) determines whether or not the particles are target particles. (page 276.e7, “Evaluation of the purity and yield’)
A delay time calculation unit ( Time management (TM)) calculates the delay time
of the particles, and according to the determination result of the sort determination unit. (page 267.e4 “Signal processing in the real-time intelligent image processor”)
Speed CMOS camera A sort signal control unit ( sort triggering ) issues a sort signal in order to sort the particles in accordance with the timing calculated by the delay time calculation unit, and a sort unit (Dual membrane push pull cell sorter ) that sorts the target particles based on the sort signal. (page 376.e5)
Nitta et al. teaches signal processing in the real to time intelligent image processor by describing that when the OI1 signal exceeds a specified threshold value, the TM node recognizes an event, assigns a cell ID number to the event, and give a time stamp as a passage time." (page 276.e4)
Thus Nitta et al teaches that the imaging flow cytometer has a configuration in which "the first particle detection unit transmits an identification number assigned on a particle-by-particle basis to the first imaging unit and the second imaging unit" and a "system time management unit" of the invention of the present application. The imaging flow cytometer has an Image construction (see, in particular, Fig. 1), that is interpreted to be an "image storage unit" as recited in applicant’s claim 1.
Nitta et al. teaches that “Architecture of the real-time intelligent image processor” beginning on page 276.e3 that uses image data and identification numbers assigned to particles, which is interpreted as clipping of particle images that are time-wised matched to the identification numbers of the particles".
Nitta et al. teaches that the slope of the linear regression line for the OI1-OI3 latency versus the OI1-OI4 latency was used to predict the sort latency, which indicates that the sorting unit operates based on the system time at the timing when the first detector and the second detector acquire the signal.
I.) Regarding applicant’s claim 1, as noted above Nitta et al. teaches all the limitations of claim1.
Therefore, Nitta et al. anticipates claim. 1
II.) Regarding applicant’s claim 3, as noted above Nitta et al. anticipates claim 1 from which claim 3 depends.
Claim 3 recites that the first imaging section and the second imaging section each include a line sensor.
Nitta et al. teaches three avalanche photodetector signals from the FDM microscope and three photodiode signals from the speed meter. (page 270, left-hand column). Note, applicant discloses that the line sensor can be an avalanche photodiode array.
Therefore, Nitta et al. anticipates claim 3.
III.) Regarding applicant’s claim 4, as noted above Nitta et al. anticipates claim 1 from which claim 4 depends.
Claim 4 recites that the first imaging section and the second imaging section are disposed along an axial direction of the channel.
Nitta et al. teaches that the cells passe through the optical interrogation points OI1 and OI3 which would necessarily be disposed along an axial direction of the channel. (page 276.e4. “Signal processing in the real-time intelligent image processor”)
Therefore, Nitta et al anticipates claim 4.
V.) Regarding applicant’s claim 5, as noted above Nitta et al. anticipates claim 1 from which claim 5 depends.
Claim 5 recites that first particle detection section transmits, to the first imaging section and the second imaging section, an identification number that is given on a particle-by-particle basis.
As noted above, Nitta et al. teaches image data and identification numbers assigned to particles.
Therefore, Nitta et al. anticipates claim 5.
VI.) Regarding applicant’s claim 6, as noted above Nitta et al. anticipates claim 1 from which claim 6 depends.
Claim 6 recites that the first imaging section and the second imaging section each transmit the clipped image of the particle and the identification number of the particle to the image storage section.
As noted above, Nitta et al. teaches that “Architecture of the real-time intelligent image processor” beginning on page 276.e3 that uses image data and identification numbers assigned to particles, which is interpreted as clipping of particle images that are time-wised matched to the identification numbers of the particles".
Therefore, Nitta et al. anticipates claim 6.
VII.) Regarding applicant’s claim 7, as noted above Nitta et al. anticipates claim 1 from which claim 7 depends.
Claim 7 recites a delay time calculation section that calculates a delay time of the particle; a sort signal control section that issues a sort signal for sorting the particle in step with a timing calculated by the delay time calculation section according to the determination of the sorting determination section; and a sorting section that sorts the objective particle based on the sort signal, wherein the delay time calculation section calculates the delay time to an arrival of the particle at the sorting section based on the system times corresponding to timings at which the first detection device and the second detection device acquired signals.
As noted above, Nitta et al. teaches delay time calculation unit ( Time management (TM)) calculates the delay time of the particles, and according to the determination result of the sort determination unit. (page 267.e4 “Signal processing in the real-time intelligent image processor”)
Further as note above Nitta et al, teaches that speed CMOS camera A sort signal control unit ( sort triggering ) issues a sort signal in order to sort the particles in accordance with the timing calculated by the delay time calculation unit, and a sort unit (Dual membrane push pull cell sorter ) that sorts the target particles based on the sort signal. (page 376.e5)
Therefore, Nitta et al, anticipates claim 7.
VIII.) Regarding applicant’s claim 8, as noted above Nitta et al. anticipates claim 7 from which claim 8 depends.
Claim 8 recites a second particle detection section that detects the particle that passes through a detection position positioned downstream from the first spot and the second spot on the channel, wherein the delay time calculation section compares an estimated arrival time of the particle at the detection position calculated based on system times at which the particle passed through the first spot and the second spot with an arrival time of the particle at the detection position detected by the second particle detection section, and the sort signal control section adjusts a timing of the sorting section sorting the objective particle based on the comparison between the estimated arrival time and the arrival time.
Nitta et al teaches when the OI1 signal exceeds a specified threshold value, the TM node recognizes an event, assigns a cell ID number to the event, and gives a time stamp as a passage
time. After a predetermined duration (typically 160 ms), the cell ID signal and the trigger signal are sent to the IC node as two channel electrical serial signals. After the OI3 signal is detected, the TM node calculates the speed and estimates the sort time. (page 276.e4 “Signal processing in the real-time intelligent image processor”)
Therefore, Nitta et al. anticipates claim 8.
IX.) Regarding applicant’s claim 9, as noted above Nitta et al. anticipates claim 7 from which claim 9 depends.
Claim 9 recites that the detection position is positioned downstream from the sorting section, the second particle detection section calculates a sort success rate of the particle, and the delay time calculation section adjusts a timing of the sorting section sorting the objective particle based on the estimated arrival time and the sort success rate.
Nitta et al. teaches “Two objective lenses A1 and A2 are aligned to image the cells flowing at the center of the microchannel while the other objective lens B is used for monitoring the sorting process with the high-speed CMOS camera. (page 276.e5 “Optics-microfluidics integration unit”)
Further Nitta et al. teaches that the sorting procedure of the intelligent IACS consists of event rate tuning, sorting, and cell/particle collection. (page 276.e7 “Sorting Experiments)
Nitta et al.’s teachings of monitoring and tuning the sorting process reads on the limitations of claim 9.
Therefore, Nitta et al. anticipates claim 9
X.) Regarding applicant’s claim 17, as noted above Nitta et al. anticipates claim 3 from which claim 17 depends.
Claim 17 recites that first imaging section and the second imaging section are disposed along an axial direction of the channel.
As noted above, Nitta et al. teaches that the cells passe through the optical interrogation points OI1 and OI3 which would necessarily be disposed along an axial direction of the channel. (page 276.e4. “Signal processing in the real-time intelligent image processor”)
Therefore, Nitta et al anticipates claim 17.
XI.) Regarding applicant’s claim 19, as noted above Nitta et al. anticipates claim 3 from which claim 19 depends.
Claim 19 recites that the first particle detection section transmits, to the first imaging section and the second imaging section, an identification number that is given on a particle-by-particle basis.
As noted above, As noted above, Nitta et al. teaches image data and identification numbers assigned to particles.
Therefore, Nitta et al. anticipates claim 19.
XII.) Regarding applicant’s claim 20, as noted above Nitta et al. anticipates claim 4 from which claim 20 depends.
Claim 20 recites that the first particle detection section transmits, to the first imaging section and the second imaging section, an identification number that is given on a particle-by-particle basis.
As noted above, Nitta et al. teaches image data and identification numbers assigned to particles.
Therefore, Nitta et al. anticipates claim 20.
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.
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.
2. Claims 2, 15, 16 and 18 are rejected under 35 USC 103 as being unpatentable over Nitta et al. as applied to claim 1 and further in view of International Patent Publication No. WO2019/167510 to Hashimoto (cited by applicant) (using U.S. Patent Application Publication No. 2021/0372917 as an English language equivalent)
I.) Regarding applicant’s claim 2, as noted above Nitta et al. anticipates claim 1 from which claim 2 depends.
Claim 2 recites that the laser unit emits the first laser light and the second laser light being different from each other in wavelength.
Nitta et al, does not teach that the laser unit emits the first laser light and the second laser light being different from each other in wavelength.
Hashimoto teaches a flow cytometer. Hashimoto teaches that “The light to be emitted by the light irradiation unit may be one light, or two or more lights. The light to be emitted by the light irradiation unit may be two lights having different wavelengths, or may be two lights having the same wavelength, for example.” {0122]
It would have been obvious to modify Nitta et al. to use a laser unit that emits the first laser light and the second laser light being different from each other in wavelength as taught by Hashimoto as a for purposes of sorting particles.
Therefore, Nitta et al. in view of Hashimoto renders claim 2 obvious.
X.) Regarding applicant’s claim 15, as noted above Nitta et al. in view of Hashimoto renders claim 2 obvious from which claim 15 depends.
Claim 15 recites that the first imaging section and the second imaging section each include a line sensor.
As noted above, Nitta et al. teaches three avalanche photodetector signals from the FDM microscope and three photodiode signals from the speed meter. (page 270, left-hand column). Note, applicant discloses that the line sensor can be an avalanche photodiode array.
Therefore, Nitta et al. in view of Hashimoto renders claim 15 obvious.
XI.) Regarding applicant’s claim 16, as noted above Nitta et al. in view of Hashimoto renders claim 2 obvious from which claim 16 depends.
Claim 16 recites that the first imaging section and the second imaging section are disposed along an axial direction of the channel.
As noted above, Nitta et al. teaches that the cells passe through the optical interrogation points OI1 and OI3 which would necessarily be disposed along an axial direction of the channel. (page 276.e4. “Signal processing in the real-time intelligent image processor”)
Therefore, Nitta et al. in view of Hashimoto renders claim 16 obvious.
XI.) Regarding applicant’s claim 18, as noted above Nitta et al. in view of Hashimoto renders claim 2 obvious from which claim 18 depends.
Claim 18 recites that the first particle detection section transmits, to the first imaging section and the second imaging section, an identification number that is given on a particle-by-particle basis.
As noted above, As noted above, Nitta et al. teaches image data and identification numbers assigned to particles.
Therefore, Nitta et al. in view of Hashimoto renders claim 18 obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/M.S.G./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798