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 .
Response to Arguments
Applicant's arguments filed 4/28/2026 have been fully considered are addressed below:
Applicant’s amendments overcome the objections of claims 1, 2-4, 10, and 12-16. The previous claim objections have been withdrawn.
Applicant’s amendments overcome the 112b rejections of claims 6, 7 and 13. The 112b rejections have been withdrawn. However, claim 13 is now objected to as explained below.
Regarding claim interpretation, the examiner notes that the claim interpretations under 112f are not rejections and the structure described in the applicant’s remarks (see page 7-8) is consistent with the examiner’s interpretations. Further, the examiner notes that the “detection device” is interpreted as “at least one detector” because claim 13 would be unclear if the “detection device” was interpreted to comprise more than one detector. Since the claim recites generic placeholders “module” and “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, the 112f claims interpretations are maintained.
Applicant's arguments with respect to the 102 and 103 rejections filed 4/28/2026 have been fully considered but they are not persuasive.
Regarding claims 1-3, 5, 6, 8, and 11-13, the applicant argues Kennington (US20190369002A1) does not teach “a detection device configured to initiate acquisition of data associated with the sample in response to the scattered light associated with the sample spacer detected by the detection device” (see remarks page 10).
However, the examiner respectfully disagrees. Kennington teaches "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" ([0056]). The claim does not require that the detection device cannot be recording data before initiating acquisition of data associated with the sample. Kennington uses the timestamp of the separation gas (scattered light) to determine when the data associated with the sample begins, thus initiating the plate sampling run which is data associated with the sample. Claims 14, 15, 16, 18, and 19 are addressed by this response (see remarks page 11).
Regarding claims 4, 7, and 17, the applicant argues Kennington does not teach “wherein the acquisition train is further configured to begin acquisition of data at a first time following the signal attaining the specified value, 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.” (see remarks page 11). The applicant argues that Kennington performs continuous data acquisition under which separation gas is merely used as a marker to between samples collected continuously and to synchronize timing between signals. The time offset described in Kennington is used to align the addition of the separation gas into the flow to specific samples detected, and Kennington does not use separation gas to determine when data acquisition should begin (see remarks page 12).
However, the examiner respectfully disagrees. As recited above with respect to claim 1, Kennington teaches "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" ([0056]). Even if Kennington performs continuous data acquisition, the data associated with the sample is initiated using the timestamp of the separation gas timing data, thus at a first time following the signal attaining the specified value. Further, under BRI, the time offset is consider to be a delay as it is “a known time offset between a flow cell event trigger and a sensor trigger” ([0074]). The examiner notes that the limitations are “optionally” are not required by the claim and as such do not need to be taught by Kennington.
Regarding claims 9, 10, and 20, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references (see remarks page 12), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, for claims 9 and 20, Norton teaches volume of the gas introduced as a bubble into the flow stream may vary depending on the volume of the sample and sample line ([0040]), thus one would select the sample space volume such that matches the sample and sample line in order to perform an accurate measurement. For claim 10, both Kennington and Norton are used to detect bubbles and fluorescent samples in a flow stream illuminated by a light source (Norton [0006]-[0007]; Kennington [0046]). 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 select the wavelength in order to efficiently excite the desired fluorescence from the sample. Further, 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.
Thus, the rejections of claims 1-20 have been maintained.
Claim Objections
Claims 13 is objected to because of the following informalities:
Regarding claim 13, in line 2, “the one detection device” should read “the one detector” as previously recited in the claim.
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 § 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 at least one 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 associated with the sample in response to the 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 the 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 the 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 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 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 associated with 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 detector, 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 at least one 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 the 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 the 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 the 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 the 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 at least one 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 at least one 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAITLYN E KIDWELL/Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877
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