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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/27/2024 was considered by the examiner.
Claim Objections
Claims 1, 2-4, 10, 12-16 are objected to because of the following informalities.
Regarding claims 1, 12, and 13, the claims recite “data related to the sample” (claim 1 line 5, claim 12 line 4, claim 13 line 3) while all other claims recite “data associated with the sample” for example claim 2 line 3. It is suggested to change “data related to the sample” to “data associated with the sample” in order to maintain consistency throughout the claims.
Regarding claim 1 and 14, the claims recite “to scattered light” (claim 1 line 6, claim 14 line 7) which should read “to the scattered light” to be consistent with claims 12 and 13 and clearly have antecedent basis.
Regarding claims 1 and 14, the claims recite “at least one light source, wherein the light source” (claim 1 line 3, claim 14 line 4) which should read “at least one light source, wherein the at least one light source” in order to maintain consistency and clearly have antecedent basis.
Regarding claim 10, the claim recites “the light source” which should read “the at least one light source” in order to maintain consistency and clearly have antecedent basis.
Regarding claim 2, 3, 4, 15, 16, the claims recite “begin acquisition of data” which should read “begin the acquisition of data” as recited in claims 5, 6, 8, 18, and 19. It is suggested to make this change in order to maintain consistency throughout the claims and clearly have antecedent basis.
Appropriate correction is required.
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: “module” in claims 1 and 14; “detection device” in claims 1, 2, 8, 14, 15, and 19.
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.
Regarding claims 1 and 14, the claim recites “a module configured to introduce a sample spacer into a sample” which uses the generic placeholder “module” 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. Accordingly, the limitation on “module” is interpreted under 35 U.S.C. 112(f) as corresponding to at least one of a valve, a pump, an injector, a cavitation apparatus, a heat source, or a gas permeable membrane ([0094]).
Further, the claims recite “a detection device” which uses the generic placeholder “device” 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. Accordingly, the limitation on “detection device” is interpreted under 35 U.S.C. 112(f) as corresponding to at least one detector ([0095]-[0096]).
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 6, 7 and 13 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.
Regarding claim 6, the claim recites “wherein the acquisition train is further configured to process the signal to generate a processed signal and begin the acquisition of data”. This limitation was already recited in claim 5 which claim 6 depends on. Is this the same “processed signal” as claim 5 or is this a different processed signal? The examiner notes that if they are the same signals, then claim 5 is likely redundant since beginning data acquisition would already imply a time at which it started. For the purposes of examination, “a processed signal “ in claim 6 is interpreted as the same “processed signal” from claim 5, and the additional limitation examined for claim 6 is “wherein the acquisition train is further configured to begin the acquisition of data at a first time following the processed signal differing from the specified value for the specified time period.” Appropriate correction is required.
Claim 7 is rejected due to its dependency on claim 6.
Regarding claim 13, the claims recites “wherein the detection device comprises one detection device”. This limitation is unclear because claim 1 already recites “a detection device” which is already one detection device. The examiner believes that this limitation was intended to recite “wherein the detection device comprises one detector, wherein the one detector is configured to detect the scattered light associated with the sample spacer and further configured to acquire data related to the sample.” This is based on claim 12 which recites a separate sample spacer detector and sample detector. Further, Figure 3A and 3B show the embodiment with the sample and sample spacer detector 124 as a single detector ([0055]). For the purposes of examiner, “one detection device” is interpreted as “one detector”. Appropriate correction is required.
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.
(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 1-3, 5, 6, 8, 11-16, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US20190369002A1 by Kennington (cited in the IDS).
Regarding claim 1, Kennington teaches a detection system (at least Fig. 1A, 1B), comprising:
a module (autosampler 102 and peristaltic pump 112; [0044]; [0045]) configured to introduce a sample spacer (separation bubbles 136 and 138; [0044]; [0046]) into a sample (samples 130, 132 and 134 ; [0044]; [0046]);
at least one light source (laser interrogation device 120; [0045]), wherein the light source illuminates the sample spacer and the sample ([0045]), wherein illumination of the sample spacer produces scattered light ([0046]; [0048]); and
a detection device ([0046]; [0047] forward detector 124, side scatter detector 128, and fluorescence detector 126; detection device can include one or more of these different detectors) configured to initiate acquisition of data related to the sample in response to scattered light associated with the sample spacer detected by the detection device ([0048]; [0056] "the timestamp output of the air bubble gap detector (separation gas timing data) can be correlated with the flow cytometer sample event data timing to synchronize the start of a plate sampling run").
Regarding claim 2, Kennington teaches a detection system of claim 1, and further teaches comprising an acquisition train ([0050]-[0054] processor; [0056] plate sampling run; the examiner notes that the applicant’s specification does not provide a definition of “acquisition train” besides the detail in [0047] that “a machine learning model can be comprised in, for example, the acquisition train of a system”. The examiner interprets “acquisition train” as the complete process of collecting data with the recited structures and a type of processing/computing/control device) configured to:
receive a signal from the detection device ([0056] “separation gas timing data generated from the captured scatter voltage signal’) and, in response to the signal, begin acquisition of data associated with the sample ([0056] "the timestamp output of the air bubble gap detector (separation gas timing data) can be correlated with the flow cytometer sample event data timing to synchronize the start of a plate sampling run").
Regarding claim 3, Kennington teaches a detection system of claim 2, and further teaches wherein the acquisition train is further configured to begin acquisition of data following the signal attaining a specified value ([0056] "In operation, separation gas timing data generated from the captured scatter voltage signal and corresponding timestamp, which is applied when the output of the scatter detector is over the set voltage threshold.").
Regarding claim 5, Kennington teaches a detection system of claim 2, and further teaches wherein the acquisition train is further configured to process the signal to generate a processed signal ([0056] "separation gas timing data generated from the captured scatter voltage signal") and begin the acquisition of data following the processed signal differing from a specified value for a specified time period ([0056] "the timestamp output of the air bubble gap detector (separation gas timing data) can be correlated with the flow cytometer sample event data timing to synchronize the start of a plate sampling run."; "separation gas timing data generated from the captured scatter voltage signal and corresponding timestamp, which is applied when the output of the scatter detector is over the set voltage threshold").
Regarding claim 6, Kennington teaches a detection system of claim 5, and further teaches wherein the acquisition train is further configured to process the signal to generate a processed signal ([0056] "separation gas timing data generated from the captured scatter voltage signal") and begin the acquisition of data at a first time following the processed signal differing from the specified value for the specified time period ([0056] "the timestamp output of the air bubble gap detector (separation gas timing data) can be correlated with the flow cytometer sample event data timing to synchronize the start of a plate sampling run."; "separation gas timing data generated from the captured scatter voltage signal and corresponding timestamp, which is applied when the output of the scatter detector is over the set voltage threshold").
Regarding claim 8, Kennington teaches a detection system of claim 2, and further teaches wherein the acquisition train is further configured to cease the acquisition of data in response to at least one of a volume of the sample analyzed, a length of time, a number of events, or receipt from the detection device of a signal associated with scattered light from an additional sample spacer ([0053] "The analysis software algorithm, executed by the processor, can consist of two portions, an initial time correlation and an air bubble gap event timing, to delineate individual microplate wells from the continuous flow cytometer data stream." [0059] "sequences of detected bubbles are used to delineate the samples, rather than sequences of low event counts between samples"; thus the detection of additional bubbles is used to cease the acquisition of data in response to at least one of a volume of the sample analyzed).
Regarding claim 11, Kennington teaches a detection system of claim 1, and further teaches wherein the module comprises at least one of a valve, a pump ([0045] peristaltic pump 112; [0044] probe 106 is allowed to intake aliquots of a separation fluid (such as air), thereby forming a separation bubble between successive samples in the fluid flow stream) , an injector, a cavitation apparatus, a heat source, or a gas permeable membrane.
Regarding claim 12, Kennington teaches a detection system of claim 1, and further teaches wherein the detection device comprises at least one sample spacer detector configured to detect the scattered light associated with the sample spacer ([0048] Separation bubble gaps are identified by analyzing the voltage output signal generated by a scatter detector, such as forward detector 124 or side scatter detector 128), and wherein the detection device further comprises at least one sample detector configured to acquire data related to the sample ([0046] Fluorescence emitted from tagged particles in the flow cell is detected by a fluorescence detector 126).
Regarding claim 13, Kennington teaches a detection system of claim 1, and further teaches wherein the detection device comprises one detection device, wherein the one detection device is configured to detect the scattered light associated with the sample spacer and further configured to acquire data related to the sample ([0046]forward scatter detector 124; [0009] Fig. 2 illustrates an example plot of a sample event waveform output from a forward scatter detector; [0010] FIG. 3 illustrates an example plot of an air bubble gap waveform output from a forward scatter detector; thus the forward scatter detector detects both scattered light from sample spacer and data related to the sample).
Regarding claim 14, Kennington teaches a system (at least Fig. 1A, 1B), comprising:
a flow cell ([0045] flow cell 118);
a module (autosampler 102 and peristaltic pump 112; [0044]; [0045]) configured to introduce a sample spacer (separation bubbles 136 and 138 ; [0044]; [0046]) into a sample (samples 130, 132 and 134 ; [0044]; [0046]);
at least one light source (laser interrogation device 120; [0045]), wherein the light source illuminates the sample spacer and the sample ([0045]), wherein illumination of the sample spacer produces scattered light ([0046]; [0048]); and
a detection device ([0046]; [0047] forward detector 124, side scatter detector 128, and fluorescence detector 126; detection device includes at least one detector) configured to initiate acquisition of data associated with the sample in response to scattered light associated with the sample spacer detected by the detection device ([0048]; [0056] "the timestamp output of the air bubble gap detector (separation gas timing data) can be correlated with the flow cytometer sample event data timing to synchronize the start of a plate sampling run").
Regarding claim 15, Kennington teaches the system of claim 14, and further teaches comprising an acquisition train (([0050]-[0054] processor; [0056] plate sampling run; the examiner notes that the applicant’s specification does not provide a definition of “acquisition train” besides the detail in [0047] that “a machine learning model can be comprised in, for example, the acquisition train of a system”. The examiner interprets “acquisition train” as the complete process of collecting data with the recited structures and a type of processing/computing/control device.) configured to:
receive a signal from the detection device and, in response to the signal, begin acquisition of data associated with the sample ([0056] "the timestamp output of the air bubble gap detector (separation gas timing data) can be correlated with the flow cytometer sample event data timing to synchronize the start of a plate sampling run").
Regarding claim 16, Kennington teaches the system of claim 15, and further teaches wherein the acquisition train is further configured to begin acquisition of data at a first time following the signal attaining a specified value ([0056] "In operation, separation gas timing data generated from the captured scatter voltage signal and corresponding timestamp, which is applied when the output of the scatter detector is over the set voltage threshold."
Regarding claim 18, Kennington teaches the system of claim 15, and further teaches wherein the acquisition train is further configured to process the signal to generate a processed signal ([0056] "separation gas timing data generated from the captured scatter voltage signal") and begin the acquisition of data following the processed signal differing from a specified value for a specified time period ([0056] "the timestamp output of the air bubble gap detector (separation gas timing data) can be correlated with the flow cytometer sample event data timing to synchronize the start of a plate sampling run."; "separation gas timing data generated from the captured scatter voltage signal and corresponding timestamp, which is applied when the output of the scatter detector is over the set voltage threshold").
Regarding claim 19, Kennington teaches the system of claim 15, and further teaches wherein the acquisition train is further configured to cease the acquisition of data in response to at least one of a volume of the sample analyzed, a length of time, a number of events, or receipt from the detection device of a signal associated with scattered light from an additional sample spacer ([0053] "The analysis software algorithm, executed by the processor, can consist of two portions, an initial time correlation and an air bubble gap event timing, to delineate individual microplate wells from the continuous flow cytometer data stream." [0059] "sequences of detected bubbles are used to delineate the samples, rather than sequences of low event counts between samples"; thus the detection of additional bubbles is used to cease the acquisition of data in response to at least one of a volume of the sample analyzed).
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 4, 7, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kennington.
Regarding claim 4, Kennington teaches a detection system of claim 3, and further teaches wherein the acquisition train is further configured to begin acquisition of data at a first time following the signal attaining the specified value ([0056] "In operation, separation gas timing data generated from the captured scatter voltage signal and corresponding timestamp, which is applied when the output of the scatter detector is over the set voltage threshold.")
Although Kennington is silent as to wherein the first time comprises a delay, the delay optionally based at least in part on at least one of a volume of the sample or a flow rate at which the sample is communicated through a flow cell in this embodiment, Kennington does address this limitation in another embodiment.
Kennington teaches wherein the first time comprises a delay (Fig. 10; [0074] time offset), the delay optionally based at least in part on at least one of a volume of the sample or a flow rate at which the sample is communicated through a flow cell ([0074] time offset may be adaptive based on the sample flow rate; [0075] flow cell 202).
Therefore it would have been well known and obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Kennington to include wherein the first time comprises a delay, the delay optionally based at least in part on at least one of a volume of the sample or a flow rate at which the sample is communicated through a flow cell as suggested by the second embodiment in order to improve measurement accuracy by correcting data ([0074]).
Regarding claim 7, Kennington teaches a detection system of claim 6, and although Kennington is silent as to wherein the first time comprises a delay, the delay optionally based at least in part on at least one of a volume of the sample or a flow rate at which the sample is communicated through a flow cell in this embodiment, Kennington does address this limitation in another embodiment.
Kennington teaches wherein the first time comprises a delay (Fig. 10; [0074] time offset), the delay optionally based at least in part on at least one of a volume of the sample or a flow rate at which the sample is communicated through a flow cell ([0074] time offset may be adaptive based on the sample flow rate; [0075] flow cell 202).
Therefore it would have been well known and obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Kennington to include wherein the first time comprises a delay, the delay optionally based at least in part on at least one of a volume of the sample or a flow rate at which the sample is communicated through a flow cell as suggested by the second embodiment in order to improve measurement accuracy by correcting data ([0074]).
Regarding claim 17, Kennington teaches the system of claim 15, and although Kennington is silent as to wherein the first time comprises a delay, the delay optionally based at least in part on at least one of a volume of the sample or a flow rate at which the sample is communicated through a flow cell in this embodiment, Kennington does address this limitation in another embodiment.
Kennington teaches wherein the first time comprises a delay (Fig. 10; [0074] time offset), the delay optionally based at least in part on at least one of a volume of the sample or a flow rate at which the sample is communicated through a flow cell ([0074] time offset may be adaptive based on the sample flow rate; [0075] flow cell 202).
Therefore it would have been well known and obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Kennington to include wherein the first time comprises a delay, the delay optionally based at least in part on at least one of a volume of the sample or a flow rate at which the sample is communicated through a flow cell as suggested by the second embodiment in order to improve measurement accuracy by correcting data ([0074]).
Claims 9, 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kennington in view of US20230408397A1 by Norton.
Regarding claim 9, Kennington teaches a detection system of claim 1, and although Kennington is silent as to wherein the sample spacer comprises a volume of from 0.5 μl to 4.0 μl, as the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller 105 USPQ 233 (1955). See MPEP 2144.05 Sec. II A. Additionally, based on Fig. 1B, the size of the sample spacer (separation bubbles 136, 138) appear to be similar in volume to the samples (130, 132, 134).
Further, Norton does address this limitation. Norton and Kennington are considered to be analogous to the present invention as they are in the same field of flow cytometers.
Norton teaches wherein the sample spacer comprises a volume of from 0.5 μl to 4.0 μl ([0040] "volume of the gas introduced as a bubble into the flow stream may vary depending on the volume of the sample and sample line and may be 0.001 μL or more, such as 0.005 μL or more, such as 0.01 μL or more, such as 0.05 μL or more, such as 0.1 μL or more, such as 0.5 μL or more, such as 1 μL or more, such as 2 μL or more, such as 3 μL or more, such as 4 μL or more, such as 5 μL or more and including 10 μL or more.").
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use gas bubbles with microliter volumes as sample spacers. Therefore, it would have been obvious to modify Kennington to include wherein the sample spacer comprises a volume of from 0.5 μl to 4.0 μl as suggested by Norton in order to vary the spacer size based on the sample size to increase accuracy and efficiency.
Regarding claim 10, Kennington teaches a detection system of claim 1, and although Kennington is silent as to wherein the light source comprises at least one of a 405 nm or a 488 nm laser, as the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller 105 USPQ 233 (1955). See MPEP 2144.05 Sec. II A. Additionally, the wavelength of the laser interrogation device 120 would be in the range to excite a fluorescent tag contained in the samples ([0044]; [0046]).
Further, Norton does address this limitation. Norton and Kennington are considered to be analogous to the present invention as they are in the same field of flow cytometers.
Norton teaches wherein the light source comprises at least one of a 405 nm or a 488 nm laser ([0050] 405 nm, 460 nm, 490 nm). Further, Norton teaches detecting fluorescence from the sample ([0060]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a laser within this range for flow cytometry. Therefore, it would have been obvious to modify Kennington to include wherein the light source comprises at least one of a 405 nm or a 488 nm laser as suggested by Norton in order to efficiently excite the desired fluorescence from the sample.
Regarding claim 20, Kennington teaches the system of claim 14, and although Kennington is silent as to wherein the sample spacer comprises a volume of from 0.5 μl to 4.0 μl, as the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller 105 USPQ 233 (1955). See MPEP 2144.05 Sec. II A. Additionally, based on Fig. 1B, the size of the sample spacer (separation bubbles 136, 138) appear to be similar in volume to the samples (130, 132, 134).
Further, Norton does address this limitation. Norton and Kennington are considered to be analogous to the present invention as they are in the same field of flow cytometers.
Norton teaches wherein the sample spacer comprises a volume of from 0.5 μl to 4.0 μl ([0040] "volume of the gas introduced as a bubble into the flow stream may vary depending on the volume of the sample and sample line and may be 0.001 μL or more, such as 0.005 μL or more, such as 0.01 μL or more, such as 0.05 μL or more, such as 0.1 μL or more, such as 0.5 μL or more, such as 1 μL or more, such as 2 μL or more, such as 3 μL or more, such as 4 μL or more, such as 5 μL or more and including 10 μL or more.").
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use gas bubbles with microliter volumes as sample spacers. Therefore, it would have been obvious to modify Kennington to include wherein the sample spacer comprises a volume of from 0.5 μl to 4.0 μl as suggested by Norton in order to vary the spacer size based on the sample size to increase accuracy and efficiency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20230408397A1 by Norton (cited above) teaches methods for determining absolute count of particles in a sample in a flow cytometer which includes the limitations of at least claim 1 and 14 in paragraph [0007].
US 20200030794 A1 by Perkins et al. (cited in the IDS) teaches systems and methods for serial flow emulsion processes which include the limitations of at least claim 1 in at least Figure 3 and claims 1-6. Perkins also teaches claims 9 ([0105]), 11 ([0367]).
US 4253846 A by Smythe et al. teaches Method And Apparatus For Automated Analysis Of Fluid Samples.
US 5268147 A by Zabetakis et al. teaches sample liquid analysis apparatus and method for the formation and supply to a conduit of a stream of successive sample liquid test packages.
US 20210394189 A1 by Carman et al. teaches system, including methods and apparatus, for spacing droplets from each other and for detection of spaced droplets.
US 20130273641 A1 by Ball et al. teaches a system and method for a flow cytometer system including a prepared sample fluid with reference beads; an interrogation zone that analyzes the prepared sample fluid; a peristaltic pump system that draws the sample fluid through the interrogation zone; and a processor that monitors a measured volume of sample fluid sampled by the peristaltic pump system and an expected sample volume based on data generated by the analysis of the sample fluid.
US 20200386604 A1 by Davis teaches systems and methods for line volume calibration.
US 20150253235 A1 by Kaduchak et al. teaches systems and methods for determining data processing settings require an accurate measurement of peak times among various channels and being able to adjust time delay settings wherein peak time is the measurement of time elapsed from the beginning of the data collection time window to the highest peak in the window.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E KIDWELL whose telephone number is (703)756-1719. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur Chowdhury can be reached at 571-272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAITLYN E KIDWELL/Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877