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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 30-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 30 recites “the sample stored in the sample container” in lines 9-10. There is insufficient antecedent basis for this limitation in the claim.
Claim 42 ends with a semicolon and appears to be incomplete.
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.
1. Claims 30-44 are rejected under 35 USC 103 as being unpatentable over U.S. Patent Application Publication No. 2006/0263905 to Mishima et al. (cited by applicant) in view of Pereira et al. (“Sampling methods to the statistical control of the production of blood Components,” Transfusion and Apheresis Science 56 (2017) 914–919).
Mishima et al. teaches blood analyzer that includes a barcode reader that reads a barcode label indicating a specimen number that is adhered tubes containing blood samples to be analyzed. The specimen numbers are used to identify patient information in a database that mutually associates and stores data such as testing day, specimen number, patient ID, measurement results of hemocyte analyzers, measurement results of blood coagulation measuring apparatuses, patient name, birth date, sex, age, blood type, ward, attending physician, specimen comments, patient comments and the like. [0107], [0144]
Mishima et al. teaches that the numbers of red blood cells and platelets can be counted [0058]. Further, measurement items can include white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit value (HCT), mean red cell volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count (PLT), red cell distribution width (RDW-SD), red cell distribution width RDW-CV), platelet distribution width PDW), mean platelet volume (MPV), percentage large platelets (P-LCR), and platelet crit (PCT). [0116]
While Mishima et al. teaches a blood analyzer, a barcode reader that reads barcode labels on tubes which correlate information with the measurement results including blood cell counts and other information in a database, Mishima et al. does not teach running statical analysis of extracted group of numbers of the blood cells.
Pereira et al. teaches running statistical analysis on blood components for purposes of quality control of the production of blood components. (Abstract)
It would have been obvious to one of ordinary skill in the art to modify Mishima et al. to use the blood analyzer, a barcode reader, barcode labels, database, etc. taught by Mishima et al. to perform statistical analysis on blood components in sample blood products as taught by Pereira et al. for purposes of classifying the production at least at least an acceptable level and conformity as taught by Pereira et al. (page 915, “Introduction” second paragraph)
The use of separate controllers to analyze a detector that counts blood cells and one that performs statistically analysis would have been obvious for purposes of conducting detector analysis and statistical analysis separately and efficiently.
I.) As noted above Mishima et al. in view of Pereira et al. renders all the elements of claim 30 obvious.
Therefore, Mishima et al. in view of Pereira et al. renders claim 30 obvious.
II.) Regarding applicant’s claim 31, as noted above Mishima et al. in view of Pereira et al. renders claim 30 obvious from which claim 31 depends.
Claim 31 recites that the second controller is programmed to run the at least one statistical analysis to derive the at least one of the statistical features on white blood cells that remain in the specimen.
Mishima et al teaches measuring white blood cells. [0054]
In Mishima et al. in view of Pereira et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to perform statistical analysis on any desired blood component, including white blood cells.
Therefore, Mishima et al. in view of Pereira et al. renders claim 31 obvious.
III.) Regarding applicant’s claim 32, as noted above Mishima et al. in view of Pereira et al. renders claim 30 obvious from which claim 32 depends.
Claim 32 recites that: the storage is configured to further store, in association with each of the plurality of the stored specimen identifications, a time record representing a production time of the blood product from which the specimen identified by a stored corresponding specimen identification is aspirated or a measurement time of the specimen identified by a stored corresponding specimen identification, wherein the specimen identification, the number of the blood cells, the product type identification, and the time record are stored in the storge as a set associated with the stored respective specimen identifications; and
the second controller is programmed to: search for a second group of specimen identifications stored in the storage in association with time records that fall within a selected time period; extract a second group of the numbers of the blood cells stored in the storage in association with the second group of specimen identifications, and; run the at least one statistical analysis on the extracted second group of the numbers of blood cells to derive a second analysis result including at least one of the statistical features.
Mishima et al. in view of Pereira et al. does not teach that: the storage is configured to further store, in association with each of the plurality of the stored specimen identifications, a time record representing a production time of the blood product from which the specimen identified by a stored corresponding specimen identification is aspirated or a measurement time of the specimen identified by a stored corresponding specimen identification, wherein the specimen identification, the number of the blood cells, the product type identification, and the time record are stored in the storge as a set associated with the stored respective specimen identifications; and
the second controller is programmed to: search for a second group of specimen identifications stored in the storage in association with time records that fall within a selected time period; extract a second group of the numbers of the blood cells stored in the storage in association with the second group of specimen identifications, and; run the at least one statistical analysis on the extracted second group of the numbers of blood cells to derive a second analysis result including at least one of the statistical features.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Mishima et al. in view of Pereira et al. to store in the database the production time of each blood product for purposes of monitoring how old the blood products are, in addition to the specimen identification, number of blood cells, product type and the time of storage, for purposes of monitoring the type of blood product.
It would have further been obvious to one of ordinary skill in the art before applicant’s effective filing date to search for one or more groups (including a second group) of specimen identifications that fall within selected time periods form the database and run statistical analysis on additional groups, to again classify the production at least at least an acceptable level and conformity as taught by Pereira et al.
Therefore, Mishima et al. in view of Pereira et al. renders claim 32 obvious.
IV.) Regarding applicant’s claim 33, as noted above Mishima et al. in view of Pereira et al. renders claim 32 obvious from which claim 33 depends.
Claim 33 recites that the selected time period includes one production cycle of the blood products.
Mishima et al. in view of Pereira et al. does not teach that the selected time period includes one production cycle of the blood products.
In Mishima et al. in view of Pereira et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to search for one or more groups (including a second group) of specimen identifications that fall within selected time periods that correspond to production cycles of the blood products for purposes of identifying any problems or issues associated with a production cycle that would affect all blood products associated with the production cycle.
Therefore, Mishima et al. in view of Pereira et al. renders claim 33 obvious.
V.) Regarding applicant’s claim 34, as noted above Mishima et al. in view of Pereira et al. renders claim 33 obvious from which claim 34 depends.
Claim 34 recites that the second controller is programmed to receive an input of the selected time period.
Mishima et al. in view of Pereira et al. does not teach that the second controller is programmed to receive an input of the selected time period.
In Mishima et al. in view of Pereira et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to use one of the separate controllers to receive an input of the selected time period(s) for purpose of using or associating the time period(s) with the statistical analysis.
Therefore, Mishima et al. in view of Pereira et al. renders claim 34 obvious.
VI.) Regarding applicant’s claim 35, as noted above Mishima et al. in view of Pereira et al. renders claim 33 obvious from which claim 35 depends.
Claim 35 recites that the second controller is programmed to receive a single validation instruction for the blood products produced or the specimens measured during the selected time period.
Mishima et al. in view of Pereira et al. does not teach that the second controller is programmed to receive a single validation instruction for the blood products produced or the specimens measured during the selected time period.
In Mishima et al. in view of Pereira et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to provide validation instructions in the controller that performs statistical analysis for purposes of using the validation instructions to determine if an analyzed blood component is valid for least an acceptable level and conformity as taught by Pereira et al.
Therefore, Mishima et al. in view of Pereira et al. renders claim 35 obvious.
VII.) Regarding applicant’s claim 36, as noted above Mishima et al. in view of Pereira et al. renders claim 32 obvious from which claim 36 depends.
Claim 36 recites that the selected time period includes cycles of time periods in which the blood products of a predetermined type are produced, and the second controller is programmed to derive the at least one of the statistical features attributed to a selected cycle of time period in which the blood products of the predetermined type are produced.
Mishima et al. in view of Pereira et al. does not teach that the selected time period includes cycles of time periods in which the blood products of a predetermined type are produced, and the second controller is programmed to derive the at least one of the statistical features attributed to a selected cycle of time period in which the blood products of the predetermined type are produced.
In Mishima et al. in view of Pereira et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to, in association with the selected time period(s), include cycles of time periods in which the blood products of a predetermined type are produced, and program the one controller to derive the at least one of the statistical features attributed to a selected cycle of time period in which the blood products of the predetermined type are produced for purposes of identifying any problems or issues associated with a production cycle that would affect all blood products associated with the production cycle.
Therefore, Mishima et al. in view of Pereira et al. renders claim 36 obvious.
VIII.) Regarding applicant’s claim 37, as noted above Mishima et al. in view of Pereira et al. renders claim 30 obvious from which claim 37 depends.
Claim 37 recites that the storage is configured to further store, in association with each of the plurality of the stored specimen identifications, a production site identification representing a production site of the blood product from which the specimen identified by a stored corresponding specimen identification is dispensed, wherein the number of the blood cells, the product type identification, and the production site identification are stored in the storage as a set associated with the respective stored specimen identifications,
and that the second controller is programmed to: search for a third group of specimen identifications stored in the storage in association with the production site identifications identifying a selected production site; extract a third group of the numbers of the blood cells stored in the storage in association with the third group of specification identifications; and run the at least one statistical analysis on the extracted third group of the numbers of blood cells to derive a third analysis result including at least one of the statistical features.
Mishima et al. in view of Pereira et al. does not teach that the storage is configured to further store, in association with each of the plurality of the stored specimen identifications, a production site identification representing a production site of the blood product from which the specimen identified by a stored corresponding specimen identification is dispensed, wherein the number of the blood cells, the product type identification, and the production site identification are stored in the storage as a set associated with the respective stored specimen identifications,
and that the second controller is programmed to: search for a third group of specimen identifications stored in the storage in association with the production site identifications identifying a selected production site; extract a third group of the numbers of the blood cells stored in the storage in association with the third group of specification identifications; and run the at least one statistical analysis on the extracted third group of the numbers of blood cells to derive a third analysis result including at least one of the statistical features.
It would have been obvious to one of ordinary skill in the art to modify Mishima et al. in view of Pereira et al. to store in the database the production site identification of each blood product (together with the number of cells, product identification, etc.) for purposes of identify the production site when the statistical analysis determines that tested sample has an unacceptable level and/or a nonconformity.
As noted above, in Mishima et al. in view of Pereira et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to search for one or more groups (including a third group) of specimen identifications that are from the same production site for purposes of identifying any problems or issues associated with a production site that would affect all blood products associated with the production site.
Therefore, Mishima et al. in view of Pereira et al. renders claim 37 obvious.
IX.) Regarding applicant’s claim 38, as noted above Mishima et al. in view of Pereira et al. renders claim 30 obvious from which claim 38 depends.
Claim 38 recites that: the detector is configured to detect a plurality of types of blood cells; the first controller is programmed to obtain the numbers of the blood cells of the respective types; the storage unit is configured to further store, in association with each of the plurality of the stored specimen identifications, a measurement item identification representing one type of the blood cells, wherein the number of the blood cells of the one type, the product type identification, and the measurement item identification are stored in the storage as a set associated with the stored respective specimen identifications; and the second controller is programmed to: search for a fourth group of specimen identifications stored in the storage in association with the measurement item identifications identifying a selected measurement item; extract a fourth group of the numbers of the blood cells stored in the storage in association with the fourth group of specimen identifications; and run the at least one statistical analysis on the extracted fourth group of the numbers of blood cells to derive a fourth analysis result including at least one of the statistical features.
Mishima et al. in view of Pereira et al. does not teach that: the detector is configured to detect a plurality of types of blood cells; the first controller is programmed to obtain the numbers of the blood cells of the respective types; the storage unit is configured to further store, in association with each of the plurality of the stored specimen identifications, a measurement item identification representing one type of the blood cells, wherein the number of the blood cells of the one type, the product type identification, and the measurement item identification are stored in the storage as a set associated with the stored respective specimen identifications; and the second controller is programmed to: search for a fourth group of specimen identifications stored in the storage in association with the measurement item identifications identifying a selected measurement item; extract a fourth group of the numbers of the blood cells stored in the storage in association with the fourth group of specimen identifications; and run the at least one statistical analysis on the extracted fourth group of the numbers of blood cells to derive a fourth analysis result including at least one of the statistical features.
As noted above, Mishima et al. teaches detecting a plurality of types of blood cells and counting blood cells and the database is configured to store specimen identification information, the number of cells and the type of cells based on separate cell counts.
As noted above, in Mishima et al. in view of Pereira et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to search for one or more groups (including a fourth group) of specimen identifications and numbers of blood cells in storage and conducting statistical analysis of a fourth group or specimens for purposes of identifying any problems or issues associated with a blood products stored from similar batches that would affect other blood products stored.
Therefore, Mishima et al. in view of Pereira et al. renders claim 38 obvious.
X.) Regarding applicant’s claim 39, as noted above Mishima et al. in view of Pereira et al. renders claim 30 obvious from which claim 39 depends.
Claim 39 recites that: the information management system includes a plurality of the blood analyzers; the storage is configured to further store, in association with each of the plurality of the stored specimen identifications, an analyzer identification identifying one blood analyzer, wherein the number of the blood cells, the product type identification, and the analyzer identification are stored in the storage as a set associated with the stored respective specimen identifications; and the second controller is programmed to: search for a fifth group of specimen identifications stored in the storage in association with the analyzer identifications identifying a selected blood analyzer; extract a fifth group of the numbers of the blood cells stored in the storage in association with the fifth group of specimen identifications, and run the at least one statistical analysis on the fifth group of the numbers of blood cells to derive a fifth analysis result including at least one of the statistical features.
Mishima et al. in view of Pereira et al. does not teach that: the information management system includes a plurality of the blood analyzers; the storage is configured to further store, in association with each of the plurality of the stored specimen identifications, an analyzer identification identifying one blood analyzer, wherein the number of the blood cells, the product type identification, and the analyzer identification are stored in the storage as a set associated with the stored respective specimen identifications; and the second controller is programmed to: search for a fifth group of specimen identifications stored in the storage in association with the analyzer identifications identifying a selected blood analyzer; extract a fifth group of the numbers of the blood cells stored in the storage in association with the fifth group of specimen identifications, and run the at least one statistical analysis on the fifth group of the numbers of blood cells to derive a fifth analysis result including at least one of the statistical features.
Mishima et al. teaches a blood analyzer and counting different types of blood cells. [0116]
It would have been obvious to one of ordinary skill in the art to modify Mishima et al. in view of Pereira et al. to include a plurality of analyzers, since the mere duplication of parts has no patentable significance unless a new and unexpected result is produced. (MPEP 2144.04(VI)(B)).
As noted above, in Mishima et al. in view of Pereira et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to store in the database identifications of each analyzer and search for one or more groups (including a fifth group) of specimen identifications and conducting statistical analysis of a fifth group of specimens analyzed by an identified analyzer for purposes of identifying any problems or issues associated with an analyzer that would affect all blood products associated with the identified analyzer.
Therefore, Mishima et al. in view of Pereira et al. renders claim 39 obvious.
XI.) Regarding applicant’s claim 40, as noted above Mishima et al. in view of Pereira et al. renders claim 30 obvious from which claim 40 depends.
Claim 40 recites that: the first controller is programmed to analyze the number of the blood cells to determine whether the blood product is an acceptable blood product; the storage is configured to further store, in association with each of the plurality of the stored specimen identifications, a determination result on whether the blood product is an acceptable blood product, wherein the number of the blood cells, the product type identification, and the determination result are stored in the storage as a set associated with the stored respective specimen identifications; the second controller is programmed to: search for a sixth group of specimen identifications stored in the storage in association with the product type identifications identifying a selected product type; extract the determination results stored in the storage in association with the sixth group of specimen identifications; run the at least one statistical analysis on the extracted determination results to derive a sixth analysis result including at least one of the statistical features; and output the sixth analysis result including at least one of statistical features.
Mishima et al. in view of Pereira et al. does not teach that: the first controller is programmed to analyze the number of the blood cells to determine whether the blood product is an acceptable blood product; the storage is configured to further store, in association with each of the plurality of the stored specimen identifications, a determination result on whether the blood product is an acceptable blood product, wherein the number of the blood cells, the product type identification, and the determination result are stored in the storage as a set associated with the stored respective specimen identifications; the second controller is programmed to: search for a sixth group of specimen identifications stored in the storage in association with the product type identifications identifying a selected product type; extract the determination results stored in the storage in association with the sixth group of specimen identifications; run the at least one statistical analysis on the extracted determination results to derive a sixth analysis result including at least one of the statistical features; and output the sixth analysis result including at least one of statistical features.
As noted above, Mishima et al. teaches counting different types of blood cells.
It would have been obvious to one of ordinary skill in the art to modify Mishima et al. in view of Pereira et al. to analyze the number of blood cells counted and conduct statistical analysis of product samples and determine whether tested blood products have an acceptable blood cell count and store in the database the determination result as a set associated with the stored respective specimen identifications.
As noted above, in Mishima et al. in view of Pereira et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to search for one or more groups (including a sixth group) of specimen identifications and conducting statistical analysis of a sixth group or specimens for purposes of identifying blood cell counts that would indicate any problems or issues associated with a production cycle that would affect other blood products.
Therefore, Mishima et al. in view of Pereira et al. renders claim 40 obvious.
XII.) Regarding applicant’s claim 41, as noted above Mishima et al. in view of Pereira et al. renders claim 30 obvious from which claim 41 depends.
Claim 41 recites that the specimen identification and the blood product identification stored in the storage in association with each other are identical to each other.
Mishima et al. in view of Pereira et al. does not teach that the specimen identification and the blood product identification stored in the storage in association with each other are identical to each other.
It would have been obvious to one of ordinary skill in the art to modify Mishima et al. in view of Pereira et al. to store in the database the specimen identification and the blood product identification in association with each other so as to be identical to each other for purposes of using either to associate with an identified blood product tested and analyzed.
Therefore, Mishima et al. in view of Pereira et al. renders claim 41 obvious.
XIII.) Regarding applicant’s claim 42, as noted above Mishima et al. in view of Pereira et al. renders claim 41 obvious from which claim 42 depends.
Claim 42 recites that the product type identification is embedded in the specimen identification and the blood product identification, and the information processing apparatus is programmed to extract the product type identification from either the specimen identification or the blood product identification and stores the extracted product type identification in the storage.
Mishima et al. in view of Pereira et al. does not teach that the product type identification is embedded in the specimen identification and the blood product identification, and the information processing apparatus is programmed to extract the product type identification from either the specimen identification or the blood product identification and stores the extracted product type identification in the storage.
It would have been obvious to one of ordinary skill in the art to modify Mishima et al. in view of Pereira et al. to embed the product type identification in the specimen identification and program the blood product identification, and the information processing apparatus to extract the product type identification from either the specimen identification or the blood product identification and stores the extracted product type identification in the storage, as a manner of correlating the product type identification in the specimen identification that are associated with one another.
Therefore, Mishima et al. in view of Pereira et al. renders claim 42 obvious.
XIV.) Regarding applicant’s claim 43, as noted above Mishima et al. in view of Pereira et al. renders claim 30 obvious from which claim 43 depends.
Claim 43 recites that the storage includes a first database configured to store the specimen identification and the number of the blood cells in the specimen identified by the specimen identification and a second database configured to store the specimen identification and the product type identification associated with the specimen identification.
Mishima et al. in view of Pereira et al. does not teach that the storage includes a first database configured to store the specimen identification and the number of the blood cells in the specimen identified by the specimen identification and a second database configured to store the specimen identification and the product type identification associated with the specimen identification.
It would have been obvious to one of ordinary skill in the art to modify Mishima et al. in view of Pereira et al. to provide the database with a first database configured to store the specimen identification and the number of the blood cells in the specimen identified by the specimen identification and a second database configured to store the specimen identification and the product type identification associated with the specimen identification for purposes of organizing and retrieving different information associated with the specimen identification.
Therefore, Mishima et al. in view of Pereira et al. renders claim 43 obvious.
XV.) Regarding applicant’s claim 44, as noted above Mishima et al. in view of Pereira et al. renders claim 30 obvious from which claim 44 depends.
Claim 44 recites that the detector includes an optical detector using a flow cytometer.
Mishima et al. teaches that the optical detection unit 21 is capable of measuring white blood cells, nucleated red blood cells, and reticulocytes by flow cytometry using a semiconductor laser.
Therefore, Mishima et al. in view of Pereira et al. renders claim 44 obvious.
Conclusion
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/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798
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