DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/23/2026 has been entered.
Response to Amendments
Applicant's amendments filed 6/23/2026 to claims 1, 8, and 16 have been entered. Claims 3, 5-7, 9, 10, 13-15, 18, and 26-31 have been canceled. Claims 32-35 have been added. Claims 1, 2, 4, 8, 11, 12, 16, 17, 19-25, and 32-35 remain pending, of which claims 1, 2, 4, 8, 11, 12, 16, 17, 19, 20, and 32-35 are being considered on their merits. Claims 21-25 remain withdrawn from consideration. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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.
Claims 1, 4, 8, 11, 12, 16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ortiz et al. (WO 2005/100979; Reference N) and as evidenced by the Coulter LH 700 Series Training Guide (2016, 167 pages; Reference U).
Ortiz teaches a method for classifying alligator white blood cells and nucleated red blood cells (NRBCs) based on an impedance method, comprising: 1) providing a Coulter LH750 hematology analyzer and which comprises impedance detectors, 2) adding a diluent and first aliquot of a blood sample to the device to obtain red blood cell parameters, 3) adding a first hemolytic reagent (i.e. Lyse S® III) to a second aliquot and a second hemolytic reagent (i.e. ErythrolyseTM II) to a third aliquot of the blood sample for a sufficient amount of time to lyse the red blood cells, 4) counting the white blood cells, 5) performing a 5-part differential analysis of white blood cells and analysis of nucleated red blood cells at a maintained/controlled temperature range of 18-28°C, and 6) generating histogram plots with cell size/volume on the horizontal axis and relative cell number on the vertical axis ([077]-[082] and figures referenced therein) wherein 7) the Coulter LH750 hematology analyzer inherently comprises an aspirator tip (e.g. sampling needle assembly) as evidenced by the Coulter LH700 Series training guide (see page 20, step 2; also the front page that the teachings therein apply to the Coulter LH750 hematology analyzer) and so anticipating claims 1, 4, 12, and 16.
Regarding claims 8, 11, and 19, if a prior art device in its normal and usual operation would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device; see M.P.E.P. § 2112.02(I). In this case, the Coulter LH 750 hematology analyzer of Ortiz in its normal and usual operation would necessarily generate a count and percentage of eosinophils, neutrophils, lymphocytes, and monocytes as part of the 5-part differential analysis as evidenced by the Coulter LH 700 Series Training Guide (page 149, “Differential Review Limit and Protocol Worksheet”, with “Ne” for neutrophils, “Ly” for lymphocytes, “Mo” for monocytes, and “Eo” for eosinophils). Therefore, Ortiz as evidenced by Coulter LH 700 Series Training Guide must necessarily anticipate the methods of claims 8, 11, 12, and 19.
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.
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.
Claims 2 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz as evidenced by the Coulter LH 700 Series Training Guide as applied to claims 1 and 16 above, and further in view of Sugiuchi et al. (J Lab Clin Med 2005;146:36–42; Reference V).
The teachings of Ortiz as evidenced by the Coulter LH 700 Series Training Guide are relied upon as set forth above in rejecting claims 1 and 16 as anticipated under 35 U.S.C. § 102.
Regarding claims 2 and 20, Ortiz does not teach heating the diluent to a preset temperature.
Sugiuchi teaches a method of quantifying total and differential white blood cell (WBC) counts in synovial fluid with an automated hematology analyzer (Abstract; Fig. 1). Sugiuchi teaches treating the synovial fluid with hyaluronidase at 37°C for 10 minutes, and then measuring total and differential WBC counts (the paragraph spanning both columns on page 37)), reading on claims 2 and 20. Sugiuchi teaches that hyaluronate and other viscous mucopolysaccharides are the main components of synovial fluid (the 1st paragraph under the Abstract on page 36), reading on claims 2 and 20.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to further heat the diluent of Ortiz to 37°C in view of Sugiuchi. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Ortiz and Suguichi are directed towards hematology analyzers and methods of detecting white blood cells thereof. The skilled artisan would have been motivated to do so because Sugiuchi teaches that heating is predictably advantageous when detecting white blood cells in synovial fluid.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 8, 11, and 19 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Ortiz as evidenced by the Coulter LH 700 Series Training Guide as applied to claims 1 and 16 above, and further in view of Shi et al. (2011 16th International Solid-State Sensors, Actuators and Microsystems Conference, Beijing, China, 2011, pp. 2956-2959; Reference W).
The teachings of Ortiz as evidenced by the Coulter LH 700 Series Training Guide are relied upon as set forth above in rejecting claims 1 and 16 as anticipated under 35 U.S.C. § 102.
Alternatively regarding claims 8, 11, and 19, Ortiz as evidenced by the Coulter LH 700 Series Training Guide does not expressly teach counting and obtaining a percentage of lymphocytes, monocytes, and granulocytes and further obtaining a percentage of eosinophils and neutrophils from the granulocyte percentage.
Shi teaches a 5-part differential count and percentage of each white blood cell (Table 5)
It would have been obvious to a person of ordinary skill in the art before the invention was filed to further count and obtain a percentage of lymphocytes, monocytes, and granulocytes and further obtain a percentage of eosinophils and neutrophils from the granulocyte percentage with the Coulter LH750 hematology analyzer of Ortiz in view of Shi. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Ortiz and Shi are in-part directed towards the Coulter LH750 hematology analyzer and methods of detecting white blood cells thereof. The skilled artisan would have been motivated to do so because combination would predictably yield more detail white blood cell counts and percentages in the methods of Oritz; see M.P.E.P. § 2143(I).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ortiz et al. (WO 2005/100979; Reference N) as evidenced by the Coulter LH 700 Series Training Guide (2016, 167 pages; Reference U).
The teachings of Ortiz as evidenced by the Coulter LH 700 Series Training Guide are relied upon as set forth above in rejecting claim 16 as anticipated under 35 U.S.C. § 102.
Regarding claim 17, Ortiz does not teach wherein the first and second hemolytic agents are the same. However, repetition of steps previously recited within a claim is on its own not inventive because it merely requires employing the well-known maxim, “If at first you don’t succeed, try, try again.” See Perfect Web Techs., Inc. v. InfoUSA Inc., 92 U.S.P.Q.2d 1849, 1856 (Fed. Cir. 2009). Repeating steps until a desired result is achieved requires only common sense and so is obvious to try, and in the absence of any showing to the contrary, is not inventive. Id. at 1854-55 (citing KSR Int’l Co. v. Teleflex Inc., 82 U.S.P.Q.2d 1385 (U.S. 2007)). See M.P.E.P. § 2143(I)(E). In this case, Ortiz clearly teaches sequentially adding two different hemolytic agents (i.e. Lyse S® III then ErythrolyseTM II) to the cell counting chamber, and so adding a second hemolytic agent being the same as the first hemolytic agent as claimed is simply an obvious variant over the methods of Ortiz absent any showing to the contrary.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz as evidenced by the Coulter LH 700 Series Training Guide as applied to claims 1, 12, and 16 above, and further in view of Wu (US 9,797,824).
The teachings of Ortiz as evidenced by the Coulter LH 700 Series Training Guide are relied upon as set forth above in rejecting claims 1, 12, and 16 as anticipated under 35 U.S.C. § 102.
Regarding claims 32 and 35, Ortiz does not teach receiving a user selection of an animal mode from multiple animal modes, wherein each animal mode is associated with an instruction in a computer-readable memory indicating, for each animal mode, a corresponding hemolytic agent and specified dosage, and a preset temperature range.
Wu teaches an automated hematology analyzer comprising a non-transitory computer-readable memory medium comprising instructions that when executed cause the processor to: dilute a sample of whole blood with a diluent, wherein the sample comprises a plurality of white blood cells, nucleated red blood cells, red blood cells, platelets, and reticulocytes; contact the sample with at least one fluorescent dye that specifically binds to and stains one or more nucleic acids in the white blood cells, the nucleated red blood cells, and/or the reticulocytes in the sample; generate a plurality of events, wherein each event comprises a plurality of light scattering signals and a fluorescence emission signal generated by a cell in the sample; separate the events into two data blocks using a fluorescent trigger, wherein the first data block includes events having a fluorescence emission signal that is below the fluorescent trigger, and the second data block includes events having a fluorescence emission signal that is above the fluorescent trigger; analyze the events in the first data block to count the number of red blood cells, platelets, and reticulocytes in the sample; and analyze the events in the second data block to count the number of white blood cells and nucleated red blood cells in the sample (claim 1). Regarding claims 1 and 16, Wu teaches maintaining a fixed temperature of 40°C ± 1°C when preparing a blood sample for analysis of blood cell type to allow for sufficient staining of the blood cells (Col. 18, line 65 through Col. 19, line 6).
Claims 32 and 35 are directed setting the apparatus to animal mode. Ortiz teaches a blood sample from animals and a device for measuring blood counts (see above teachings). Given Wu’s teaching on temperature control, it would be obvious for one of ordinary skill in the art to select any particular preset mode corresponding to the proper temperature, hemolytic agent, and dosage on a computer-readable medium comprising instructions as set forth by Wu. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control the temperature as taught by Wu in the blood differential test/method of Ortiz. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Ortiz and Wu are all directed in-part towards hematology or fluid analyzer devices and methods of use therein, and because and Wu are directed towards maintaining a specific temperature. The ordinary artisan would have been motivated to do so because Wu teaches the importance of maintaining the blood sample at 40°C to allow for sufficient staining of the blood cells. Therefore, modifications to Ortiz’s method to control temperature would be considered advantageous as provided by the teachings of Wu and as provided by non-transitory computer-readable memory medium comprising instructions of Wu. Absent evidence of unexpected results, the act of selecting proper conditions is obvious as the routine optimization of known parameters in methods of classifying blood cells; see M.P.E.P. § 2144.05.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz Wu as evidenced by the Coulter LH 700 Series Training Guide as applied to claims 1, 12, 16, and 32 above, and further in view of Kong (CN 101470109) and Merck (“Normal Rectal Temperature Range”).
The teachings Ortiz and Wu as evidenced by the Coulter LH 700 Series Training Guide are relied as set forth above.
Regarding claims 33 and 34, Ortiz and Wu do not teach preset temperature range for felines and canines.
Kong’s general disclosure relates to a method for improving the accuracy of leukocyte classifying result of blood samples (see Abstract). Regarding claim 14, Kong teaches animal blood samples includes dogs and cats or canines and felines (see Abstract).
Merck’s general disclosure relates to normal body temperatures for pets. Regarding claim 14-15, Merck teaches that normal body temperatures of dogs and cats is around 37.5-39.2°C and 38.1-39.2°C, respectively (see page 1).
Given the above teachings of Wu and the normal body temperatures of dogs and cats, setting/maintaining or controlling the temperature near normal body temperature of the subject is advantageous to providing good accurate results. It is noted that where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (See MPEP 2144.05 I). It is noted that “where 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” (See MPEP 2144.05 II).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood differential test/method of Ortiz to include animal subjects such as cats and dogs as taught by Kong. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Kong teaches dogs and cats as exemplary subjects for blood cell detection, and because Merck teaches the normal and expected temperature range of dogs and cats. The ordinary artisan would have been motivated to do so because it is reasonable to expect that the blood of other animals such as cats and dogs would function similarly or the same in the blood differential test of Ortiz. Therefore, these modifications to Ortiz’s test/method are expected variants as provided by the teachings of Kong.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 12-18 of the reply have been fully considered, but not found persuasive of error over the new grounds of rejection necessitated by the instant claim amendments.
Conclusion
No claims are allowed. No claims are free of the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Xiang et al. (Int. Jnl. Lab. Hem (2015), 37, 597-605; Reference X).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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