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 group I in the reply filed on 12/22/2025 is acknowledged. Claims 17, 19-20, 25-26 and 69-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/08/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-9, 12, 14, 16-17, 19-20, 25-26 and 69-70 are pending with claims 1-9, 14 and 16 being examined and claims 17, 19-20, 25-26 and 69-70 deemed withdrawn. Claims 10-11, 13, 15, 18, 21-24 and 27-68 are canceled.
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 14 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 14 is rendered indefinite as it depends on canceled claim 13.
Claim 16 is rejected based on being dependent on claim 14.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9, 12, 14 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The instant rejection reflects the Guidance published in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidelines (Vol. 84, No. 4, Monday January 7, 2019 at 50) and the October 2019 Updated Subject Matter Eligibility Guidance (hereinafter both referred to as the “Guidance”).
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Are the claims directed to a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea (Prong One); If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With regard to (1), the instant claims recite an “automated system comprising a data processing module comprising a processor and a non-transitory computer readable medium”, and therefore the answer is "yes".
With regard to (2A), Prong One, under the broadest reasonable interpretation (BRI), the instant claims recite claim steps directed to the judicial exception that is an abstract idea of the type that is in the grouping of “mental process” or “mathematical concepts” (See MPEP 2106.04(a)(2) subsections (I) and (III)) because said operations could be performed in the mind. Mental operations and mathematical concepts in the instant claims are recited as: “compare one or more cell population parameter to compare one or more cell population parameters comprising the monocyte or granulocyte cell population parameter to a threshold”.
In summary, the claim(s) recite(s) an automated system comprising a data processing module comprising a processor and a non-transitory computer readable medium wherein the non-transitory computer readable medium stores instructions that, when executed by the processor, configure the processor to perform a method, which uses mathematical algorithms/formulas as a form of an abstract idea.
Said recited judicial exception steps are directed to processing, storing and analyzing information against other stored parameters and comparing results, which under the BRI, cover performance of the limitations in the mind and mathematical concepts, as said steps under said interpretation would involve a making a mental comparison and mental correlation or mathematical correlation. Thus, if a claim, under its BRI, covers performance of the limitation in the mind, but for the recitation of generic computer elements, then it falls within the “mental processes” grouping of abstract ideas (see MPEP 2106.04(a)(2)(III)(C)).
Because the claims are directed to abstract ideas, they must further be analyzed under Prong Two to determine if said judicial exceptions are integrated into a practical application as determined by further assessment of the “additional steps” recited in the claims. With respect to Prong Two, the additional elements and the rationale pertaining to why the additional elements are not integrated, are as follows:
(a) The claims recite mathematical process (judicial exception) which are not integrated into a practical application because the system describes “storing instructions to perform a method, analyzing a monocyte” In summary, the claim(s) recite(s) an automated system comprising a data processing module comprising a processor and a non-transitory computer readable medium wherein the non-transitory computer readable medium stores instructions that, when executed by the processor, configure the processor to perform a method, but the automated system that performs a method of analyzing a monocyte does not describe a resultant action/step that is taken by applying the linked determination of the information stored, and therefore the method does not add a meaningful limitation to the abstract idea;
(b) Although the claims recite a non-transitory computer readable medium configured to store instructions executed by the processor to perform a method to analyze a monocyte or granulocyte cell population, the claims do not apply the exception, as the claim does not transform the automated system to a different state or thing beyond its ordinary purpose (See MPEP 2106.05(f) and MPEP 2106.05(c));
(c) A non-transitory computer readable medium (or memory) is recited at a high level of generality (as a generic and well-known structure) such that it is no more than mere instructions to apply the exception using a generic computer/diagnostic system (see MPEP 2106.04(a)(2)(III)(C) and MPEP 2106.05(d));
(d) The claims include storing information in the memory, which is recited at a high level of generality (i.e., generic computer and processor performing generic computer functions) such that the recitations amount to no more than instructions to apply the judicial exceptions on said generic computer (See MPEP 2106.05(f)).
As such, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea.
Because the claims fail under (2A), the claims are further evaluated under (2B). The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception under (2B) because, as discussed above with regard to integration of the recited abstract idea into a practical application, the additional elements herein amount to no more than an automated system that includes generic computer elements (memory), which do not provide an inventive concept as a generic diagnostic system with a computer is well-understood, routine and conventional. Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because (1) the memory and automated system are being used in their ordinary capacity and are merely tools to execute the abstract idea (See MPEP 2106.05(d)), (2) the additional claim elements of determining and linking (compare cell population parameter results) information, whether considered individually or as a whole, do not meaningfully limit the judicial exception (See MPEP 2106.05(e)), (3) the claims recite insignificant extra-solution activity because the activity of using an automatic determination system to link/store information is not inventive since all automated diagnostic systems have memory that are used to control the processing (See MPEP 2106.05(g)).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the features represent an abstract idea. Dependent claims 2-9, 12, 14 and 16 amount to no more than determining information, and linking information, which is an intangible abstract idea or mathematical concept, and similarly does not integrate the exception into a practical application or include additional elements that amount to significantly more. The instant claims do not include an inventive concept.
Thus, in light of the above considerations the claims remain non-statutory, and are thus not patent eligible under 35 U.S.C. 101.
Step 1: Claims 1-9, 12, 14 and 16 are directed towards an automated system.
Step 2A, Prong One: Claim 1 recites the abstract idea, “store instructions that, when executed by the processor, configure the processor to perform a method…” Abstract human reasoning or a generic computer is required to store the instructions and perform a method.
Claim 2 recites the abstract idea, “analyzing the monocyte or granulocyte cell population parameter…” Abstract human reasoning or a generic computer is required to analyze the monocyte or granulocyte cell population parameter.
Claim 4 recites the abstract idea “analyzing the monocyte or granulocyte…” Abstract human reasoning or a generic computer is required analyze the monocyte or granulocyte.
Claim 7 recites the abstract idea “analyzing the monocyte or granulocyte…”, “analyzing standard deviation of neutrophil volume…” Abstract human reasoning or a generic computer is required analyze the monocyte or granulocyte.
Claim 8 recites the abstract idea “analyzing the monocyte or granulocyte…” analyzing standard deviation of neutrophil volume…”, “analyzing mean EGC lower median angle light scatter…” Abstract human reasoning or a generic computer is required analyze the monocyte or granulocyte, the standard deviation of neutrophil volume and analyzing mean EGC lower median angle light scatter.
Claim 9 recites the abstract idea “analyzing the monocyte or granulocyte…”, “comparing one or more cell population parameters comprising the monocyte or granulocyte cell population parameter to a threshold…” Abstract human reasoning or a generic computer is required analyze the monocyte or granulocyte and compare one or more cell population parameters comprising the monocyte or granulocyte cell population parameter to a threshold.
Claim 12 recites the abstract idea “evaluating MIS-C associated with SARS-CoV-2 based at least in part on the monocyte or granulocyte population parameter…”, “evaluating the monocyte or granulocyte population parameter in combination with an additional parameter…” Abstract human reasoning or a generic computer is required to evaluate MIS-C associated with SARS-CoV-2 based at least in part on the monocyte or granulocyte population parameter and evaluate the monocyte or granulocyte population parameter in combination with an additional parameter.
Claim 14 recites the abstract idea “evaluating MIS-C associated with SARS-CoV-2 based at least in part on the monocyte or granulocyte population parameter…”, “analyzing evaluating a combination of parameters…” Abstract human reasoning or a generic computer is required to evaluate MIS-C associated with SARS-CoV-2 based at least in part on the monocyte or granulocyte population parameter, and analyze evaluating a combination of parameters.
Step 2A, Prong Two: These judicial exceptions are not integrated into a practical application because upon evaluating the automated system comprising a non-transitory computer readable medium, nothing further is performed with the abstract evaluation.
Step 2B: Claim 1 recites the elements “store instructions that, when executed by the processor, configure the processor to perform a method…”
Claim 2 recites the element “analyzing the monocyte or granulocyte cell population parameter …”
Claim 4 recites “analyzing the monocyte or granulocyte …”
Claim 7 recites “analyzing the monocyte or granulocyte…”, “analyzing standard deviation of neutrophil volume …”
Claim 8 recites “analyzing the monocyte or granulocyte…”, “analyzing standard deviation of neutrophil volume…”, “analyzing mean EGC lower median angle light scatter …”
Claim 9 recites “analyzing the monocyte or granulocyte…”, “comparing one or more cell population parameters comprising the monocyte or granulocyte cell population parameter to a threshold …”
Claim 12 recites “evaluating MIS-C associated with SARS-CoV-2 based at least in part on the monocyte or granulocyte population parameter…”, “evaluating the monocyte or granulocyte population parameter in combination with an additional parameter …”
Claim 14 recites “evaluating MIS-C associated with SARS-CoV-2 based at least in part on the monocyte or granulocyte population parameter…”, “analyzing evaluating a combination of parameters …”
These elements are interpreted as extra-solution activity which are incidental to the primary process and are mere data gathering which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity).
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 1-2 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carter (Peripheral immunophenotypes in children with multisystem inflammatory syndrome associated with SARS-CoV2 infection; hereinafter “Carter” already of record).
Regarding claim 1, Carter teaches an automated system (Carter; page 1709 Col. 1 para 6, line 19 “all samples were analyzed on a five laser BD Fortessa”) for evaluating multisystem inflammatory syndrome in children (Carter; Title) (MIS-C) associated with SARS-CoV-2, the system comprising: a light source (Carter; page 1709 Col. one of the five laser disclosed) configured to irradiate cells of a body fluid sample;
one or more light scatter detector units (Carter; implicit for the five laser BD Fortessa flow cytometer) configured to measure light scattered from the light source scattered by the cells in the body fluid sample;
a data processing module comprising a processor and a non-transitory computer readable medium (Carter; implicit for the BD Fortessa flow cytometer), wherein the non-transitory computer readable medium stores instructions that, when executed by the processor, configure the processor to perform a method comprising:
analyzing a monocyte (Carter; fig. 4a “monocyte CD14) or granulocyte cell population parameter determined for the body fluid sample based on data from the one or more light scatter detector units; and
evaluating MIS-C associated with SARS-CoV-2 (Carter; fig. 4d “Patient positive by RT-PCR for SARS-CoV-2”) based at least in part on the monocyte or granulocyte population parameter (Carter; page 1703. Col. 1 [para] 5 lines 4-5 to Col. 2 lines 1-3).
Regarding claim 2, Carter teaches the system of claim 1 (see above), wherein analyzing the monocyte or granulocyte cell population parameter comprises analyzing a monocyte cell population parameter. The limitation was discussed above in claim 1.
Regarding claim 12, Carter teaches the system of claim 1 (see above), wherein evaluating MIS-C associated with SARS-CoV-2 based at least in part on the monocyte or granulocyte population parameter comprises evaluating the monocyte or granulocyte population parameter in combination with an additional parameter selected from a group consisting of: C-reactive protein (CRP) (Carter; page 1701. Col 2 [para] 3 lines 1-2 to page 1702 Col. 1 lines 1-3 “C-Reactive Protein”).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Carter (Peripheral immunophenotypes in children with multisystem inflammatory syndrome associated with SARS-CoV2 infection; hereinafter “Carter” already of record).
Regarding claim 9, Carter teaches the system of claim 1 (see above) to include analyzing the monocyte or granulocyte cell population parameter (see above).
Carter does not teach wherein analyzing the monocyte or granulocyte cell population parameter, analyzing the monocyte or granulocyte cell population parameter to compare one or more cell population parameters comprising the monocyte or granulocyte cell population parameter to a threshold
It would have been obvious when analyzing the monocyte or granulocyte cell population parameter to compare one or more cell population parameters comprising the monocyte or granulocyte cell population parameter to a threshold.
This would allow to evaluate immune system function , detect infections and identify hematological malignancies.
Claims 3-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Carter (Peripheral immunophenotypes in children with multisystem inflammatory syndrome associated with SARS-CoV2 infection; hereinafter “Carter” already of record) in view of Ramirez et al. (US 20190128906 A1; hereinafter “Ramirez).
Regarding claim 3, Carter teaches the system of claim 2 (see above) to include analyzing the monocyte or granulocyte cell population parameter (see above).
Carter fails to teach wherein the monocyte cell population parameter comprises monocyte distribution width (MDW).
However, Ramirez teaches the analogous art of an automated system (Ramirez; [0007 “automated system) wherein the monocyte cell population parameter comprises monocyte distribution width (MDW) (Ramirez; [0019]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Carter’s monocyte or granulocyte cell population parameter to include monocyte distribution width (MDW) as taught by Ramirez because Ramirez teaches an automated system (Ramirez; [0007] “automated system”) wherein the monocyte cell population parameter comprises monocyte distribution width (MDW) (Ramirez; [0019]).
This would allow to identify abnormal cell volume variation.
Regarding claim 4, Carter teaches the system of claim 1 (see above) to include analyzing a monocyte or granulocyte cell population parameter (see above).
Carter fails to teach wherein analyzing the monocyte or granulocyte cell population parameter comprises analyzing a granulocyte cell population parameter.
However, Ramirez teaches the analogous art of an automated system (Ramirez; [0007 “automated system) wherein analyzing the monocyte or granulocyte cell population parameter comprises analyzing a granulocyte cell population parameter (Ramirez; [0081]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Carter’s monocyte or granulocyte cell population parameter to analyze a granulocyte cell population parameter as taught by Ramirez because Ramirez teaches an automated system (Ramirez; [0007] “automated system”) wherein analyzing the monocyte or granulocyte cell population parameter comprises analyzing a granulocyte cell population parameter (Ramirez; [0081]).
This would allow to collect data to correlate to blood cell morphology (Ramirez; [0081]).
Regarding claim 8, Carter teaches the system of claim 1 (see above) to include analyzing the monocyte or granulocyte cell population parameter (see above).
The analysis of standard deviation of neutrophil volume was discussed in claim 7 above.
Carter fails to teach wherein analyzing the mean EGC lower median angle light scatter (EGC LMALS MEAN).
However, Ramirez teaches the analogous art of an automated system (Ramirez; [0007] “automated system”). Ramirez teaches a first value of a first cell population and a second value of a second cell population (Ramirez; Abstract) wherein granulocytes can be part of the first or second cell population (Ramirez; claim 20) wherein determining the first cell population volume the optical parameter may be lower median angle light scatter (LMALS) (Ramirez; [0034]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Carter’s monocyte or granulocyte cell population parameter to include lower median angle light scatter as taught by Ramirez because Ramirez teaches an automated system (Ramirez; [0007] “automated system”). Ramirez teaches a first value of a first cell population and a second value of a second cell population (Ramirez; Abstract) wherein granulocytes can be part of the first or second cell population (Ramirez; claim 20) wherein determining the first cell population volume the optical parameter may be lower median angle light scatter (LMALS) (Ramirez; [0034]).
This allows to acquire data on the monocyte and granulocyte cytoplasmic membrane structure.
Claims 5-6, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Carter (Peripheral immunophenotypes in children with multisystem inflammatory syndrome associated with SARS-CoV2 infection; hereinafter “Carter” already of record) in view of Ramirez et al. (US 20190128906 A1; hereinafter “Ramirez) further in view of Nigro (Performance of an automated immature granulocyte count as a predictor of neonatal sepsis; hereinafter “Nigro” already of record).
Regarding claim 5, Carter teaches the system of claim 4 (see above) to include a granulocyte cell population parameter (see above).
Carter fails to teach wherein the granulocyte cell population parameter comprises early granulocytes (EGC).
However, Nigro teaches the analogous art of an automated system (Nigro; page 619. Col. 1, lines 10-12) wherein the granulocyte cell population parameter comprises early granulocytes (EGC) (Nigro; (Title).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Carter’s granulocyte cell population parameter to include early granulocytes (EGC) as taught by Nigro because Nigro teaches an automated system (Nigro; page 619. Col. 1, lines 10-12) wherein the granulocyte cell population parameter comprises early granulocytes (EGC) (Nigro; (Title).
This allows to identify bone marrow response to inflammation.
It is well known in the art that early granulocytes are also known as immature granulocytes.
Regarding claim 6, Carter teaches the system of claim 4 (see above) to include a granulocyte cell population parameter (see above).
Carter fails to teach wherein the granulocyte cell population parameter comprises immature granulocyte count (IG COUNT).
However, Nigro teaches the analogous art of an automated system (Nigro; page 619. Col. 1, lines 10-12) wherein the granulocyte cell population parameter comprises immature granulocyte count (IG COUNT) (Nigro; Title).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Carter’s granulocyte cell population parameter to include early granulocytes (EGQ) as taught by Nigro because Nigro teaches an automated system (Nigro; page 619. Col. 1, lines 10-12) wherein the granulocyte cell population parameter comprises early granulocytes (EGQ) (Nigro; (Title).
This allows to identify bone marrow response to inflammation.
Regarding claim 14, Carter teaches the system to include evaluating MIS-C associated with SARS-CoV-2 based at least in part on the monocyte or granulocyte population parameter (see above).
Carter fails to teach wherein: analyzing evaluating a combination of parameters comprising at least two parameters selected from the group consisting of: a monocyte cell population parameter, a granulocyte cell population parameter, and a red blood cell population parameter;
the monocyte cell population parameter is a parameter selected from a group consisting of; MDW, mean monocyte volume (Mo DC Mean), standard deviation of monocyte axial light loss (MoAllSD), and reactive monocytes (RE-MONO).
However, Ramirez teaches the analogous art of an automated system (Ramirez; [0007] “automated system”) that includes analyzing evaluating a combination of parameters (Ramirez; Table 1) wherein analyzing evaluating a combination of parameters comprising at least two parameters selected from the group consisting of: a monocyte cell population parameter (Ramirez; [0030]); the monocyte cell population parameter is a parameter selected from a group consisting of; MDW (Ramirez; [0019]).
To one of ordinary skill in the rat before the effective filing date of the invention it would have been obvious to modify Carter’s evaluating MIS-C associated with SARS-CoV-2 based at least in part on the monocyte or granulocyte population parameter to include analyzing evaluating a combination of parameters comprising at least two parameters selected from the group consisting of: a monocyte cell population parameter; the monocyte cell population parameter is a parameter selected from a group consisting of; MDW as taught by Ramirez because Ramirez teaches an automated system (Ramirez; [0007] “automated system”) that includes analyzing evaluating a combination of parameters (Ramirez; Table 1) wherein analyzing evaluating a combination of parameters comprising at least two parameters selected from the group consisting of: a monocyte cell population parameter (Ramirez; [0030]); the monocyte cell population parameter is a parameter selected from a group consisting of; MDW (Ramirez; [0019]).
This would allow to collect data to correlate to blood cell morphology (Ramirez; [0081]).
Carter fails to teach the granulocyte cell population parameter is a parameter selected from a group consisting of: mean neutrophil volume (NeDCMean), mean EGC lower median angle light scatter (Egc_Lmals_Mean), mean EGC median angle light scatter(EgcMalsMean), EGC, mean neutrophil lower median angle light scatter(NeLmalsMean), mean neutrophil median angle light scatter (NeMals_Mean),standard deviation of neutrophil axial light loss (Ne_All_SD), standard deviation of neutrophil volume (Ne_DC_SD), mean neutrophil axial light loss(NeAllMean), standard deviation of neutrophil low angle light scatter(NeLalsSD), mean EGC axial light loss (EgcAllMean), standard deviation of neutrophil lower median angle light scatter (NeLmals_SD), mean EGC opacity(EgcOpMean), standard deviation of EGC upper median angle light scatter(EgcUmals_SD), neutrophil granularity (NEUT-GI), neutrophil activation(NEUT-RI), and IG COUNT; the red blood cell population parameter is a parameter selected from a group consisting of: red blood cells (Rbc), hemoglobin (Hgb), hematocrit (Hct), standard deviation of non-nucleated red blood cell opacity (NNrbcOpSD), mean opacity of mature red blood cells (NreticOpMean), mean nucleated red blood cell derivative of axial light loss (NrbcAL2Mean), hypochromatic red blood cells (HYPO-HE),hyperchromatic red blood cells (HYPER-HE), reticulocyte haemoglobin equivalent (RET-HE), nucleated red blood cells (NRBC), microcytic red blood cells (MICROR), macrocytic red blood cells (MACROR), and fragmented red blood cells (FRC).
However, Nigro teaches the analogous art of an automated system (Nigro; page 619. Col. 1, lines 10-12) that includes a granulocyte cell population parameter (Nigro; Title), wherein the granulocyte cell population parameter is a parameter selected from a group consisting of: IG Count (Nigro; Title), and nucleated red blood cells (NRBC) (Nigro; page 623, Col. 1, paragraph 5, lines 10-11).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Carter’s evaluating MIS-C associated with SARS-CoV-2 based at least in part on the monocyte or granulocyte population parameter to include a granulocyte cell parameter selected from a group consisting of IG Count and nucleated red blood cells (NRBC) as taught by Nigro because Nigro teaches an automated system (Nigro; page 619. Col. 1, lines 10-12) that includes a granulocyte cell population parameter (Nigro; Title), wherein the granulocyte cell population parameter is a parameter selected from a group consisting of: IG Count (Nigro; Title), and nucleated red blood cells (NRBC) (Nigro; page 623, Col. 1, paragraph 5, lines 10-11).
This would allow to collect data to correlate to blood cell morphology (Ramirez; [0081]).
Regarding claim 16, Carter teaches the system of claim 14 (see above) to include a combination of parameters (see above).
Carter fails to teach the combination of parameters comprises a lymphocyte cell population parameter selected from a group consisting of: standard deviation of lymphocyte volume (LyDCSD), standard deviation of lymphocyte axial light loss (LyAllSD), lymphocyte lower median angle light scatter standard deviation (LyLmalsSD), lymphocyte median angle light scatter standard deviation (LyMalsSD), lymphocyte low angle light scatter standard deviation (LyLalsSD), standard deviation of lymphocyte opacity(LyOpSD), reactive lymphocytes (RE-LYMP), and antibody-synthesizing lymphocytes(AS-LYMP).
However, Ramirez teaches the analogous art of an automated system (Ramirez; [0007 “automated system) that includes a combination of parameters (Ramirez; Table 1) wherein the combination of parameters comprises a lymphocyte cell population parameter selected from a group consisting of: standard deviation of lymphocyte volume (LyDCSD), lymphocyte lower median angle light scatter standard deviation (LyLmalsSD), lymphocyte median angle light scatter standard deviation (LyMalsSD) (Ramirez; Table 1).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Carter’s combination of parameters to include a lymphocyte cell population parameter selected from a group consisting of: standard deviation of lymphocyte volume (LyDCSD), standard deviation of lymphocyte axial light loss (LyAllSD), lymphocyte lower median angle light scatter standard deviation (LyLmalsSD), lymphocyte median angle light scatter standard deviation (LyMalsSD), lymphocyte low angle light scatter standard deviation (LyLalsSD) as taught by Ramirez because Ramirez teaches an automated system (Ramirez; [0007] “automated system”) that includes a combination of parameters (Ramirez; Table 1) wherein the combination of parameters comprises a lymphocyte cell population parameter selected from a group consisting of: standard deviation of lymphocyte volume (LyDCSD), standard deviation of lymphocyte axial light loss (LyAllSD), lymphocyte lower median angle light scatter standard deviation (LyLmalsSD (Ramirez; Table 1).
This would allow to collect data to correlate to blood cell morphology (Ramirez; [0081]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carter (Peripheral immunophenotypes in children with multisystem inflammatory syndrome associated with SARS-CoV2 infection; hereinafter “Carter” already of record) in view of Huo et al. (US 6472215 B1; hereinafter; ”Huo”).
Regarding claim 7, Carter teaches the system of claim 1 (see above) to include analyzing the monocyte or granulocyte cell population parameter (see above).
Carter fails to teach wherein analyzing the monocyte or granulocyte cell population parameter comprises analyzing standard deviation of neutrophil volume.
However, Huo teaches the analogous art of an automated system (Huo; Col. 9 lines 29-30) to include analyzing monocyte population (Huo; fig. 1A-B) wherein analyzing the monocyte or granulocyte cell population parameter comprises analyzing standard deviation of neutrophil volume (Huo; Col. 7 lines 1-5).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Carter’s granulocyte cell population parameter to include analyzing standard deviation of neutrophil volume as taught by Huo because Huo teaches an automated system (Huo; Col. 9 lines 29-30) to include analyzing monocyte population (Huo; fig. 1A-B) wherein analyzing the monocyte or granulocyte cell population parameter comprises analyzing standard deviation of neutrophil volume (Huo; Col. 7 lines 1-5).
This allows to obtain information regarding neutrophil maturity and activation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 272-1295. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798