DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 05/26/2026 is acknowledged.
Claims 20-22, 27 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/26/2026.
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.
Claim 10 is 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.
The term “relevance” in claim 10 is a relative term which renders the claim indefinite. The term “relevance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The examiner notes that applicant does give examples of what the language could mean in the instant specification relative to the limitations of claim 10. However it is not an explicit definition and as such it still remains unclear what would fall within and outside of the term relevance relative to the 1st and 2nd calculations of claim 10. Therefore for examination purposes the examiner is interpreting the term as non-limiting, and for understanding of the claim as being replaced with merely “comparing”. The examiner suggests for compact prosecution that the claim simply be amended with the actual examples from the instant specification to remove any ambiguity.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 12-13, 15 and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McKirdy (U.S. PGPub No. 2021/0217518 A1).
As to claim 1, McKirdy discloses and shows in figure 1D and 12A, a method for operating and monitoring the cleaning of a sample processing instrument, comprising steps, performed by a control device (PPG/Diagnostic system/circuitry disclosed), ([0113], ll. 1-9) of :
directing a first sample through a flow cell in the sample processing instrument, wherein the first sample comprises first particles (e.g. blood in one of the example sample use cases) ([0052]; [0105], ll. 1-7; [0109], where “Siemens Advia 120” is a flow cytometer that contains a flow cell, further as explicitly disclosed McKirdy is used in conjunction with flow cells);
processing the first sample (e.g. combine with reagent as disclosed) ([0106], ll. 1-8);
cleaning the flow cell of the sample processing instrument with a cleaning agent (bleach or other cleaning fluids as disclosed) ([0105], ll. 11-15);
measuring a carryover amount in the flow cell after the cleaning (i.e. wash cycle), wherein the carryover amount comprises a measurement associated with an amount of the first particles remaining in a measurement region of the flow cell (i.e. the definition of the term “carryover”) ([0109]; [0111], ll. 1-11);
comparing the measured carryover amount against a predetermined target value (i.e. acceptable performance as disclosed), wherein the target value corresponds to a value indicative of a cleaning requirement ([0111], ll. 1-11); and
determining, based on the comparison, whether the cleaning requirement is met (I.e. acceptable or not) ([0111], ll. 1-11).
As to claim 2, McKirdy discloses a method, further comprising: repeating the cleaning step when it is determined that the cleaning requirement is not met; and stopping a cleaning process when it is determined that the cleaning requirement has been met or when a number of cleaning cycles reaches a maximum threshold (i.e. run automatically until acceptable performance is met) ([0111], ll. 1-11).
As to claim 3, McKirdy discloses a method, wherein the target value is input by a user ([0111], ll. 1-11; where implicitly at some point a user input a value defining “acceptable” as the variable clearly did not define itself).
As to claim 4, McKirdy discloses a method, wherein the cleaning step comprises: selecting the cleaning agent from a plurality of cleaning agents configured to clean the flow cell ([0105], ll. 11-15; i.e. bleach or other cleaning fluids as explicitly disclosed of which one must be selected).
As to claims 12-13, McKirdy discloses a method, further comprising: directing a second sample through the sample processing instrument following the determination that the cleaning requirement is met; and processing the second sample and wherein the second sample is directed through the sample processing instrument automatically by the control device in response to the determination that the cleaning requirement is met ([0110]; i.e. the reptation as the function of a “next test” as disclosed).
As to claim 15, McKirdy discloses a method, wherein the sample processing instrument is a flow cytometer, and wherein processing the first sample comprises determining one or more properties of the first particles in the first sample by directing an optical beam toward the flow cell and measuring light emitted or scattered from within the flow cell ([0105]; [0107], ll. 1-6; [0134]; as noted above the “Siemens Advia 120” is a flow cytometer).
As to claim 35, McKirdy disclose and shows in figure 1D, a system for operating and monitoring the cleaning of a sample processing instrument, comprising:
a fluid pipeline (tubing, explicitly shown in figure 12A, but further inherently required in a flow cell to get any fluid from a sample holder to the flow cell area) communicating fluid sources to a flow cell of the sample processing instrument ([0027]; [0052]; [0108], ll. 1-8)
a pump (fluidic device #1) arranged in the fluid pipeline ([0052]; [0109]; as disclosed a pump can be present in the fluid pipeline path) and
a control device (PPG/Diagnostic system/circuitry disclosed) configured to ([0113], ll. 1-9):
direct a first sample through the flow cell in the sample processing instrument, wherein the first sample comprises first particles (e.g. blood in one of the example sample use cases) ([0052]; [0105], ll. 1-7; [0109], where “Siemens Advia 120” is a flow cytometer that contains a flow cell, further as explicitly disclosed McKirdy is used in conjunction with flow cells);
process (e.g. combine with reagent as disclosed) the first sample ([0106], ll. 1-8);
control the pump to pump a cleaning agent through the fluid pipeline for cleaning the flow cell, and pump a monitoring solution (i.e. carry-over test fluid) through the fluid pipeline ([0105]; [0109]; [0111]; where implicitly the pumps explicitly disclosed are used to relay the cleaning fluid as the system);
measuring a carryover amount in the flow cell after the cleaning (i.e. wash cycle), wherein the carryover amount comprises a measurement associated with an amount of the first particles remaining in a measurement region of the flow cell (i.e. the definition of the term “carryover”) ([0109]; [0111], ll. 1-11);
comparing the measured carryover amount against a predetermined target value (i.e. acceptable performance as disclosed), wherein the target value corresponds to a value indicative of a cleaning requirement ([0111], ll. 1-11); and
determining, based on the comparison, whether the cleaning requirement is met (I.e. acceptable or not) ([0111], ll. 1-11).
As to claim 36, McKirdy discloses a system, wherein the control device is further configured to: repeatedly clean the flow cell when it is determined that the cleaning requirement is not met; and stop a cleaning process when it is determined that the cleaning requirement has been met or when a number of cleaning cycles reaches a maximum threshold (i.e. until acceptable carry-over performance characteristic is determined) ([0111], ll. 1-11).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over McKirdy in view of Kawamura et al. (WO 2021/1149759 where the examiner is using the linked U.S. PGPub 2023/0039952 A1 for citations).
As to claim 6, McKirdy does disclose pumping a monitoring solution through the flow cell; directing an optical beam (from the sources disclosed) toward the flow cell ([0109]; [0110], ll. 1-7);
McKirdy does not explicitly disclose measuring light scattered from within the flow cell, wherein the measured light corresponds to the carryover amount in the flow cell.
However, Kawamura does disclose in ([0038]) that in flow cytometry two of the most common analysis regimes are either scattered or fluorescent light measurement. Obviously, McKirdy could also merely use scattering measurements as well when checking for left over particles after cleaning as it is one of the most well-known and practiced detection methods for particle analysis.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McKirdy with a measuring light scattered from within the flow cell, wherein the measured light corresponds to the carryover amount in the flow cell in order to provide the advantage of expected results in using the basic concept of light scattering measurements to measure a sample area under test in a predictable and well-known means and determine what is or isn’t left within the measured area.
As to claim 7, McKirdy discloses ae method, wherein the monitoring solution is different from the cleaning agent (i.e. bleach vs “carry-over test fluid”) ([0105]; [0109]).
As to claims 8 or 10, McKirdy does not explicitly disclose a method, wherein the carryover amount comprises a count of the first particles, a carryover rate of the first particles, or a concentration of the first particles within the flow cell or calculating, by the control device, based on the measured carryover amount, at least one of: 1) a value representative of relevance of the carryover amount to the monitoring solution; and 2) a value representative of relevance of the carryover amount after cleaning and an amount of the first particles in a sample before cleaning.
However, Kawamura does disclose in ([0204]; [0216]-[0217]) counting the total number of residual beads as a count of carryover rate. Obviously residual is synonymous with carryover in this case. Further the value output of the residual beads is being interpreted as a monitoring solution carryover amount.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McKirdy with a method, wherein the carryover amount comprises a count of the first particles, a carryover rate of the first particles, or a concentration of the first particles within the flow cell or calculating, by the control device, based on the measured carryover amount, at least one of: 1) a value representative of relevance of the carryover amount to the monitoring solution; and 2) a value representative of relevance of the carryover amount after cleaning and an amount of the first particles in a sample before cleaning in order to provide the advantage of a precise and simple manner to define carryover/residual of cells present relative to a cleaning process with which one can clearly define threshold values to define desired cleaning requirements further Kawamura explicitly discloses the beads as a calibration tool used to increase the accuracy of the flow system..
Claim(s) 37-38, are rejected under 35 U.S.C. 103 as being unpatentable over McKirdy in view of McDevitt et al. (U.S. PGPub No. 2005/0191620 A1).
As to claims 37 or 38, McKirdy does not explicitly disclose a system, further comprising a switching device, wherein the switching device is configured to enable the pump to be in fluid communication selectively with a sample needle fitted in the flow cell or a sample source of the fluid sources or wherein the switching device comprises a three-way valve including a first port connected to the pump, a second port connected to the sample needle and a third port connected to the sample source, and wherein the three-way valve is switched between a first position allowing the pump to communicate with the sample needle and a second position allowing the pump to communicate with the sample source.
However, McDevitt does disclose and show in figure 34 and in ([0371]) the basic concept of using a three-way valve (1040) linked to on one port to a pump (1020) another port a sample needle (1030) and finally on the final port a sample source (1060). This simple three-way valve system allowed for efficient relaying of a sample and buffer solution (or obviously cleaning fluid) to interact with the sample needle and also provides the benefit that fluid can easily be flushed into a waste reservoir (890).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McKirdy with a system, further comprising a switching device, wherein the switching device is configured to enable the pump to be in fluid communication selectively with a sample needle fitted in the flow cell or a sample source of the fluid sources or wherein the switching device comprises a three-way valve including a first port connected to the pump, a second port connected to the sample needle and a third port connected to the sample source, and wherein the three-way valve is switched between a first position allowing the pump to communicate with the sample needle and a second position allowing the pump to communicate with the sample source in order to provide the advantage of increased versatility and expected results in using a common three-way valve switching device configuration one can relay multiple samples/buffers/cleaners to the sample needle and flow cell in an efficient and predictable manner, further as taught by McDevitt this allows for an easy link to a waste reservoir for efficient cleaning/waste removal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P LAPAGE whose telephone number is (571)270-3833. The examiner can normally be reached Monday-Friday 8-5:30.
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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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/Michael P LaPage/Primary Examiner, Art Unit 2877
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