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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 20-21, 24-31, and 34-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-10, and 17 of U.S. Patent No. 11,898,952. Although the claims at issue are not identical, they are not patentably distinct from each other because all the subject matter of claims 20-21, 24-31, and 34-39 is also claimed in U.S. Patent No. 11,898,952; more specifically, please see the following claim correspondences:
Claims of current application
Claims of U.S. Patent No. 11,898,952
20
1
21
1
24
4
25
5
26
6
27
7
28
8
29
1 and 9-10
30
17
34
4
35
5
36
6
37
7
38
8
39
1 and 9-10
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 20-39 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 30 reads, “the first light detector detects the optical information at a first position on the flow channel, and the second light detector detects the optical information at a second position on the flow channel different from the first position.” It’s unclear to the examiner whether “a first position” and “a second position” requires: 1) detecting light scattered/emitted from two different positions of the flow channel; 2) the light detectors to be positioned at two different positions of the flow channel; 3) both 1 and 2; 4) either 1 or 2. This lack of clarity causes the scope of the claim to be indefinite. For the sake of examination, it will be interpreted as 4.
Claim 20 reads, “a plurality of light detectors configured to detect, at different positions, optical information emitted from the microparticles that flow through the flow channel” and “the first light detector detects the optical information at a first position on the flow channel, and the second light detector detects the optical information at a second position on the flow channel different from the first position.” It’s unclear to the examiner whether “different positions,” “a first position” and “a second position” requires: 1) detecting light scattered/emitted from two different positions of the flow channel; 2) the light detectors to be positioned at two different positions of the flow channel; 3) both 1 and 2; 4) either 1 or 2. This lack of clarity causes the scope of the claim to be indefinite. For the sake of examination, it will be interpreted as 4.
Note: for the sake of compact prosecution, for the case where the detectors are positioned at different locations, see the parent application 17/276,529
Claim Rejections - 35 USC § 102/103
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 30-35 and 39 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by Ito (US 20140299522 A1; cited by Applicant) or, in the alternative, under 35 U.S.C. 103 as obvious over Ito in view of Norton (US 5880474 A; cited by Applicant).
Regarding claim 30, Ito teaches a microparticle measuring method, comprising:
detecting optical information emitted from microparticles that flow through a flow channel at different positions by a plurality of light detectors (light detectors, 7;“position different” in paragraph 68; different lenses in paragraphs 80-81; figures 1 and 3);, wherein
the plurality of light detectors includes:
a first light detector (two of the four detectors in 7) that includes a first plurality of light detection channels, and
a second light detector (the other two of the four detectors in 7) that includes a second plurality of light detection channels, wherein
the first light detector detects the optical information at a first position on the flow channel (figure 1), and
the second light detector detects the optical information at a second position on the flow channel (figure 1) different from the first position (note that detectors 73a and 73c corresponds to one detector, while detectors 73b and 73d correspond to the other detector; also note that 73a detects excitation light from light source 3, while 73b detectors speed light from light source 4, and therefore detect light that is emanated at different points in the flow stream, as explained in paragraphs 68 and 74; the positions are separated by a distance of L1); and
controlling a detection timing of each light detection channel of the second plurality of light detection channels (paragraphs 88-89; controlling the time that is calculated as the detection time) based on:
a trigger signal detected at a first reference channel (ch1 or ch2) of the first plurality of light detection channels of the first light detector (paragraphs 88-89), and
an optical signal detected at a second reference channel (the other of ch1 or ch2) of the second plurality of light detection channels of the second light detector (paragraphs 88-89).
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For the reasons given above, the examiner considers Ito teaching the above limitations. Alternatively, if one were to consider Ito as not teaching controlling a detection timing of each light detection section, Norton is directed to a similar invention and teaches controlling a detection timing of each light detection section (column 1, lines 60 – column 2, line 5). Additionally, Norton teaches this provides the benefit of analyzing the detector signals during a time when there is a high probability that the detector signal is indicative of characteristics of the particle of interest (column 1, lines 60 – column 2, line 5). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the detection timing control section of Ito configured to control a detection timing of each light detection section in order to analyze the detector signals during a time when there is a high probability that the detector signal is indicative of characteristics of the particle of interest.
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Regarding claim 31, Ito teaches controlling a detection process period of the second light detector based on a time period in which the optical signal detected at the second reference channel exceeds a threshold value (figure 4A and paragraphs 88-89).
Regarding claim 32, Ito teaches the optical signal is detected based on the trigger signal (“each channel” in paragraphs 88-89).
Regarding claim 33, Ito teaches a detection process period of each channel, except the second reference channel, of the second plurality of light detection channels of the second light detector are controlled based on the optical signal (“each channel” in paragraphs 88-89; the claimed “each channel, except the reference channel” corresponds to three of the four channels, for example, channels 1,3, and 4, and since all of the channels are controlled based on the optical signal, then channels 1, 3, and 4 are controlled based on the optical signal).
Regarding claim 34, Ito teaches the trigger signal detected at the first reference channel is optically equal to the optical signal detected at the second reference channel (figure 2; equal because they’re both forward scatter data from same particles).
Regarding claim 35, Ito teaches a voltage signal into which the trigger signal detected at the first reference channel is converted is identical in height (H), area (A), and width (W) with a voltage signal into which the optical signal detected at the second reference channel is converted (figure 2; identical because they’re both forward scatter data from same particles).
Regarding claim 39, Ito teaches sorting the microparticles based on the detected optical information (2; figure 1; paragraphs 64 and 54).
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.
Claims 20-25 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Ito in view of Norton and Terazono (US 20130029407 A1)
Regarding claim 20, Ito teaches a microparticle measuring apparatus (also see the citations with respect to the corresponding method limitations), comprising:
a liquid sample flow channel (1; paragraph 60 and figure 1),
a liquid sheath flow channel (paragraphs 62 and 80)
a sorting flow channel (2; paragraph 64 and figure 1),
wherein the sorting flow channel is connected to the flow channel (figure 1);
a plurality of light detectors configured to detect, at different positions, optical information emitted from the microparticles that flow through the flow channel (light detectors, 7;“position different” in paragraph 68; different lenses in paragraphs 80-81; figures 1 and 3), wherein
the plurality of light detectors includes:
a first light detector (two of the four detectors in 7) that includes a first plurality of light detection channels, and
a second light detector (the other two of the four detectors in 7) that includes a second plurality of light detection channels,
the first light detector detects the optical information at a first position on the flow channel (figure 1), and the second light detector detects the optical information at a second position on the flow channel different from the first position (note that detectors 73a and 73c corresponds to one detector, while detectors 73b and 73d correspond to the other detector; also note that 73a detects excitation light from light source 3, while 73b detectors speed light from light source 4, and therefore detect light that is emanated at different points in the flow stream, as explained in paragraphs 68 and 74; the positions are separated by a distance of L1); and
circuitry configured to control a detection timing of each light detection channel of the second plurality of light detection channels (paragraph 88-89; controlling the time that is calculated as the detection time) based on:
a trigger signal detected at a first reference channel (ch1 or ch2) of the first plurality of light detection channels of the first light detector (paragraphs 88-89), and
an optical signal detected at a second reference channel (the other of ch1 or ch2) of the second plurality of light detection channels of the second light detector (paragraphs 88-89).
For the reasons given above, the examiner considers Ito teaching the above limitations. Alternatively, if one were to consider Ito as not teaching controlling a detection timing of each light detection section, Norton is directed to a similar invention and teaches controlling a detection timing of each light detection section (column 1, lines 60 – column 2, line 5). Additionally, Norton teaches this provides the benefit of analyzing the detector signals during a time when there is a high probability that the detector signal is indicative of characteristics of the particle of interest (column 1, lines 60 – column 2, line 5). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the detection timing control section of Ito configured to control a detection timing of each light detection section in order to analyze the detector signals during a time when there is a high probability that the detector signal is indicative of characteristics of the particle of interest.
Ito doesn’t explicitly teach
a liquid sample reservoir connected to a liquid sample flow channel, wherein the liquid sample reservoir is configured to store a liquid sample including microparticles;
a liquid sheath reservoir connected to a liquid sheath flow channel, wherein the liquid sample flow channel and the liquid sheath flow channel are connected to a flow channel;
a sorted liquid reservoir connected to a sorting flow channel;
a waste liquid reservoir connected to a discarding flow channel, wherein the discarding flow channel is connected to the flow channel;
Like Ito (and like Applicant), Terazono is directed to a microparticle measuring apparatus and particle sorter and teaches a liquid sample reservoir connected to a liquid sample flow channel, wherein the liquid sample reservoir is configured to store a liquid sample including microparticles; a liquid sheath reservoir (paragraphs 142) connected to a liquid sheath flow channel, wherein the liquid sample flow channel and the liquid sheath flow channel are connected to a flow channel; a sorted liquid reservoir connected to a sorting flow channel; a waste liquid reservoir connected to a discarding flow channel, wherein the discarding flow channel is connected to the flow channel (paragraphs 142-144 and figures 14-15; also see paragraphs 49-55).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that it comprises the reservoirs described above connected to the flow channels in order to be able to run the particle measurements and sorting for a long time without stopping to make new connections to add more liquid or remove the sorted particles and waste and thus achieve faster measurement and sorting.
Regarding claim 21, Ito teaches the circuitry is further configured to control a detection process period of the second light detector based on a time period in which the optical signal detected at the second reference channel exceeds a threshold value (figure 4A and paragraphs 88-89).
Regarding claim 22, Ito teaches the optical signal is detected based on the trigger signal (“each channel” in paragraphs 88-89).
Regarding claim 23, Ito teaches a detection process period of each channel, except the second reference channel, of the second plurality of light detection channels of the second light detector are controlled based on the optical signal (“each channel” in paragraphs 88-89; the claimed “each channel, except the reference channel” corresponds to three of the four channels, for example, channels 1,3, and 4, and since all of the channels are controlled based on the optical signal, then channels 1, 3, and 4 are controlled based on the optical signal).
Regarding claim 24, Ito teaches the trigger signal detected at the first reference channel is optically equal to the optical signal detected at the second reference channel (figure 2; equal because they’re both forward scatter data from same particles).
Regarding claim 25, Ito teaches a voltage signal into which the trigger signal detected at the first reference channel is converted is identical in height (H), area (A), and width (W) with a voltage signal into which the optical signal detected at the second reference channel is converted (figure 2; identical because they’re both forward scatter data from same particles).
Regarding claim 29, Ito teaches a sorting section configured to sort the microparticles based on the optical information detected by the plurality of light detectors (2; figure 1; paragraphs 64 and 54).
Claims 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Ito and Norton, as applied to claim 30 above, and further in view of Saiyed (US 20140374630 A1; cited by Applicant).
Regarding claims 36-38, Ito doesn’t explicitly teach a flow-rate controller configured to control a flow rate of the microparticles on a basis of the trigger signal detected at the first reference channel and the optical signal detected at the second reference channel (claim 36); the flow-rate controller is further configured to control the flow rate of the microparticles such that the microparticles pass between the first light detection section and the second light detection section for a fixed time (claim 37); the flow-rate controller is further configured to control the flow rate of the microparticles by controlling a liquid sheath feeding pressure (claim 38).
Saiyed is directed to a similar method and system and teaches a flow-rate control section configured to control a flow rate of the microparticles on a basis of the trigger signal detected at the first reference channel and the optical signal detected at the second reference channel ; the flow-rate control section controls the flow rate of the microparticles such that the microparticles pass between the first light detection section and the second light detection section for a fixed time; the flow-rate control section controls the flow rate of the microparticles by controlling a liquid sheath feeding pressure (figures 1 and 7, including the arrows in figures 1 and 7; paragraphs 27-28 and 51).
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It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination by having a flow-rate control section (as described above) in order to use all available information to ensure that the flow rate of the particles is at the desired and optimal setting for the optical measurements to ensure high quality, accurate, and precise data.
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Ito, Norton, and Terazono as applied to claim 20 above, and further in view of Saiyed.
Regarding claims 26-28, Ito doesn’t explicitly teach a flow-rate controller configured to control a flow rate of the microparticles on a basis of the trigger signal detected at the first reference channel and the optical signal detected at the second reference channel (claim 26); the flow-rate controller is further configured to control the flow rate of the microparticles such that the microparticles pass between the first light detection section and the second light detection section for a fixed time (claim 27); the flow-rate controller is further configured to control the flow rate of the microparticles by controlling a liquid sheath feeding pressure (claim 28).
Saiyed is directed to a similar method and system and teaches a flow-rate control section configured to control a flow rate of the microparticles on a basis of the trigger signal detected at the first reference channel and the optical signal detected at the second reference channel ; the flow-rate control section controls the flow rate of the microparticles such that the microparticles pass between the first light detection section and the secon light detection section for a fixed time; the flow-rate control section controls the flow rate of the microparticles by controlling a liquid sheath feeding pressure (figures 1 and 7, including the arrows in figures 1 and 7; paragraphs 27-28 and 51).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination by having a flow-rate control section (as described above) in order to use all available information to ensure that the flow rate of the particles is at the desired and optimal setting for the optical measurements to ensure high quality, accurate, and precise data.
Additional Prior Art
Masataka (WO 2010095391 A1) is also directed to a microparticle analysis device (abstract) and teaches using a plurality of counter electrodes to sort particles (6, 21).
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Durack (US 20140212917 A1) is also directed to an optical microparticle measurement system (abstract and figures) and teaches add a first time period and a second time period to the set light detection process period, wherein the first time period is added prior to the set light detection process period, and the second time period is added subsequent to the set light detection process period (paragraph 73, where the light detection process period corresponds to the period of the trigger signal; also see figures 3A-3G which illustrate that this provides the benefit of creating additional observation windows that correspond to measurements at additional points on the trajectory of the particles).
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Fox (US 20080319680 A1) reads, “the event window generator can be programmed so that event windows can be made longer by simply adding a time extension to the event window via the processor 130.” (paragraph 38)
Ito (US 20140299522 A1; previously cited) discloses
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Norton (US 5880474 A; previously cited) reads, “In general, a trigger determines a window of time within which interesting data is expected and, therefore, data processing is activated. Often, a trigger is initiated when a scatter detector output crosses a threshold--indicating with a high level of certainty that a particle is in the flow-path location corresponding to the detector.” (column 1, lines 60-65).
WO 2007009983 A1 reads, “Advantageously, other operating parameters of the device can be set, such as the duration before trigger” and “the triggering time of the sorting means is moved by adding a part of the duration of the actuation tB”
US 20180090906 A1 reads, “determining a pause duration before triggering..” (paragraph 30).
US 20050162648 A1 teaches adding a delay after each period and reads, “[0071] A second method of preventing the first source of anomalous data is to require a scatter detector signal of sufficient amplitude to cross the first trigger threshold value in order to initiate an "event" and then to enable subsequent triggers using the "event" signal. With this method, there should also be a time out means, which limits the duration of the "event" if one or more of the subsequent trigger threshold values are not crossed. In a simple implementation, a single time-out means is initiated by the beginning of an "event" and reaches a terminal count slightly after the expected end of the "event" if all of the required triggers have not occurred.
“[0075] If the capture system is rearmed immediately after a "missed event" ends and is then triggered by a closely following next event, both events may be present within the capture window. One method of preventing this problem is to hold off the rearming of the capture process by a time period that extends beyond the end of the leading event by a preselected delay time period. The preselected delay time period may be, for example, equal to about half of the capture window width. Every event resets and restarts the delay time period.”
US 5880474 A reads, "one or a combination of photodetector outputs can be used to derive a trigger signal that activates processing, including digitization" (column 1, lines 45-55)
S 20170074776 A1 reads, "As mentioned earlier, most flow cytometers have multiple detectors, and each such detector may have its own dedicated second pulse processor 120. In such instances, the second threshold value 118 may be supplied to the second pulse processor 120 that receives the same detector signal 104 that is fed into the first pulse processor 106. When that second pulse processor 120 detects the start and end of a pulse, according to the second threshold value 118, this may be used as a “trigger” that causes data processed by all of the second pulse processors 120 during that interval to be sstored in a storage system, e.g., a hard drive or solid state drive, of the flow cytometer. It is also contemplated that multiple threshold values for different detectors could be used in combination to “trigger” recording, e.g., in order to trigger a data recording event, a first detector's signal must meet or exceed a first threshold while a second detector's signal meets or exceeds a second threshold. In theory, every detector could have a corresponding threshold value, and triggering could be configured to occur in any number of circumstances dependent on whether one or more of those threshold values was met or exceeded at a given time. (paragraph 49)
US 20170074776 A1 reads, "[0062] As can be seen in this example triggering, there are three detectors 102-102a, 102b, and 102c—that each provide a corresponding detector signal 104a, 104b, and 104c, ... [0065] It is to be understood that while this example shows only three detectors and two first pulse processors/real-time trigger modules, the principles discussed herein may be applied in systems having any number of detectors and/or first pulse processors/real-time trigger modules. At some point, however, the number of variables to consider in setting a second threshold value may become too overwhelming to be useful (at least, for human operators) if too many first pulse processors/real-time trigger modules are used in the determination of the second threshold values.
Conclusion
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/RUFUS L PHILLIPS/ Examiner, Art Unit 2877