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 .
Response to Amendments
Applicant's amendments filed 2/02/2026 to claims 1, 8, 11, 16, and 19 have been entered. Claims 3, 6, 7, 9, 10, 13, and 26-31 are canceled. Claims 1, 2, 4, 5, 8, 11, 12, 14, and 16-25 remain pending, of which claims 1, 2, 4, 5, 8, 11, 12, and 14-20 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 Claims 21-25 remain withdrawn from consideration.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 Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.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 § 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.
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 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 1, 2, 4, 5, 8, 11, 12, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 10,024,858) in view of Lock (US 3,884,640) and Wu (US 9,797,824) and as evidenced by Grenier et al. (Mol. Nutr. Food Res. 2011, 55, 761–771).
Grenier teaches that the Coulter LH500 device is inherently/necessarily an impedance analyzer (p763, subheading 2.4). Therefore, a teaching in the prior art towards Coulter LH500 device and using said device to count white blood cells inherently reads on using an impedance method of claim 1; see M.P.E.P. § 2112.
Smith’s general disclosure relates to a portable blood count monitor and describes sample preparation, measurement, and analysis method that permits accurate characterization of red blood cells, and white blood cells, including differentials of the white blood cell count (see Abstract).
Regarding claims 1 and 16, Smith teaches the device comprises sampling chamber, wherein each chamber can be analyzed for different analytes, i.e. different types of blood cells (see col. 8, lines 23-24). A subject provides a small volume of blood sample to a chamber (see col. 18, lines 41-42), which can be obtained by a sampling needle or a “finger-prick” (see col. 4, lines 19-20). The chambers can be pre-packaged with one or more reagent or a hemolytic agent (see col. 8, lines 30-37) and can comprise a diluent, a dye, and other chemical compounds, wherein a dilution can provide an optimum concentration for the analysis of an analyte with a reagent (see col. 8, lines 48-50). Smith teaches that white cell differentiation and useful reagents therefor need to be kept within specific temperatures (see col. 13, lines 31-36). Smith teaches a first and second reagent, wherein the first reagent detects a red blood cell in the body fluid by sphering the red blood cell and a second reagent that differentiates white blood cell in the blood fluid from the red blood cells (hemolytic agent) (see claim 1). Smith teaches analyzers automated and are capable of performing 5-part differential subpopulation counts of white blood cells and comprises measuring in-part an impedance change (see col. 4, lines 24-50). Smith teaches running the samples on a Coulter LH500 HematologyTM device (Example 3), reading on claim 1 as evidenced by Grenier. Therefore, an ordinary artisan could reasonably arrive at the claimed invention of claim 1, wherein a diluent is added to a counting chamber, a sample is obtained to be analyzed, at least one hemolytic agent is added, temperature is controlled, and testing is performed to obtain a total of four white blood cells counts or classifications (differentials), given the teachings of Smith.
Regarding claims 2 and 20, Smith teaches that white cell differentiation and useful reagents therefor need to be kept within specific temperatures (see col. 13, lines 31-36). It is within the skill of an ordinary artisan to heat a diluent or reagent to a desired or optimal temperature within or outside of the counting chamber to maintain the chamber within a desired temperature range.
Regarding claims 4, 5, and 16, Smith teaches that a chamber can contain a reagent capable of detecting an analyte or a cell type and/or a lysing reagent (see col. 9, lines 60-63). Smith teaches that the first and second reagent chambers can contain various reagents, for example, one or more of surfactants, dying agents, lysing agents, dry form reagent, liquid reagents, and predetermined volumes of a diluent (see col. 21, lines 43-46). For example, the first sampling chamber can be for analyzing white blood cells and can include a lysis agent to lyse red blood cells to facilitate white blood cell analysis (see col. 21, lines 59-62). Smith teaches the different subpopulations can be grouped according to their range of fluorescent responses across two or more frequencies; wherein two-dimensional or even higher dimension histograms (fluorescent intensities at different wavelengths or wavelength ranges and light scatter measurements) can be created and analyze (see col. 16, lines 56-64). Given the teachings of Smith, an ordinary artisan would recognize that that adding a hemolytic agent once or twice to obtain a first and/or second white blood cell histogram is routine and conventional in the art. As discussed above, , Smith teaches analyzers are capable of performing 5-part differential subpopulation counts of white blood cells (see col. 4, lines 36-28). Therefore, absent of unexpected results performing four classifications and counting of the white blood cells using a hemolytic agent or agents and using one or two histograms is obvious in view of the art.
Regarding claims 8, 11, and 19, Smith teaches that a 5-part differential count includes neutrophils, lymphocytes, monocytes, eosinophils, and basophil. Further, Smith teaches that a count can give the percentage of white blood cells that are of a particular type, for example, granulocytes and monocytes. By multiplying the percentage with the total number of white blood cells, the absolute number of each type of white can be obtained (see col. 4, lines 59-67). For example, the cells can be divided into a plurality of distinct groups based on their fluorescence; the first, second, third, and fourth groups can correspond to number of neutrophils, lymphocytes, monocytes, and platelets respectively if desired (see col. 19, lines 17-32; and FIG. 5) . Also as seen in Table 1, the percentages and/or counts are provided for red blood cells, platelets, white blood cells, granulocytes, lymphocytes, and monocytes (see col. 25-26; and FIG. 11). Given the provided teaching and teachings above regarding histograms, it would be obvious to an ordinary artisan that using these histograms an ordinary artisan could get the count and percentages of any of the five identified differentials: neutrophils, lymphocytes, monocytes, eosinophils, and basophil. Absent of unexpected results, an ordinary artisan would have reasonable expectation of success in doing so given Smith’s teachings. Further, it is obvious to remove other debris in order to get an accurate count of the desired cell type; i.e. removing RBC fragments to get an accurate count of the desired cell type lymphocytes using a lysis agent as discussed above.
Regarding claim 12, Smith teaches the body fluid can be a blood sample (see col. 6, lines 52-54). Smith teaches subject can be for example elderly adults, adults, adolescents, pre-adolescents, children, toddlers, or infants (see col. 18, lines 22-24). Under broadest reasonable interpretation, humans are included under the category of animals.
Regarding claim 17 and 18, Smith teaches that a chamber can contain a reagent capable of detecting an analyte or a cell type and/or a lysing reagent (see col. 9, lines 60-63). Smith teaches that the first and second reagent chambers can contain various reagents, for example, one or more of surfactants, dying agents, lysing agents, dry form reagent, liquid reagents, and predetermined volumes of a diluent (see col. 21, lines 43-46). If desired, an ordinary artisan would recognize they could use the same hemolytic agent in the first and second sampling chambers. Absent of unexpected results, the difference of dosage between the first and second hemolytic agents is obvious in view of the art. Through routine experimentation, an ordinary artisan with the desire of performing two white blood cell histograms and teachings of Smith could arrive at the claimed invention of claims 17 and 18 and have reasonable expectation of success in doing so.
Regarding claims 1 and 16, Smith 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.
Lock’s general disclosure relates to an apparatus for measuring characteristics of a fluid, e.g. blood (see Abstract) . Regarding claims 1 and 16, Lock teaches an apparatus wherein temperature will be controlled to provide the specimen at normal 37°C value of recognized importance, or any other pre-selected value (see col. 2, lines 49-51; col. 3, lines 22-26; col. 5, lines 24-32).
Regarding claims 1 and 16, 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 (Col. 18, line 65 through Col. 19, line 6).
Regarding claim 1 and 16, the claim is directed setting the apparatus to animal mode. Smith teaches a blood sample from humans/an animal and a device for measuring blood counts (see above teachings). Given Lock’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 Lock in the blood differential test/method of Smith. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Smith, Lock, and Wu are all directed in-part towards hematology or fluid analyzer devices and methods of use therein, and because Lock and Wu are directed towards maintaining a specific temperature. The ordinary artisan would have been motivated to do so because Lock teaches the importance of maintaining the blood sample near body temperature for more accurate readings of blood parameters (see col. 2, lines 24-51) and an ordinary artisan would recognize excessive hot or cold temperatures may impact structure, viscosity, or other parameters of white blood cells, which need to be maintained to provide accurate results. Therefore, modifications to Smith’s method to control temperature would be considered advantageous as provided by the teachings of Lock and as provided by non-transitory computer-readable memory medium comprising instructions of Wu. Absent evidenced 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 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Smith, Lock and Wu as applied to claim 1 above, and further in view of Kong (CN 101470109) and Merck (“Normal Rectal Temperature Range”).
The teachings Smith, Lock, and Wu are above are relied as set forth above.
Smith, Lock and Wu do not teach: preset temperature range for felines and canines (see claims 14-15).
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 Lock 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 Smith 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 Smith. Therefore, these modifications to Smith’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 for the reasons given below.
In response to applicant's argument on pages 12-13 of the reply that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., any step requiring image acquisition and image analysis) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Nevertheless, Smith teaches a visual imaging system in Example 3 as cited.
On pages 13-15 of the reply, Applicant alleges that Smith is deficient by utilizing the LH500 impedance analyzer device as a comparative benchmark for hematological analysis. This is not found persuasive of error because Smith clearly and unambiguously teaches a method for classifying white blood cells based on an impedance method, comprising: adding a diluent to a white blood cell counting chamber; adding a sample to be analyzed to the white blood cell counting chamber; adding the corresponding hemolytic agent in the specified dosage for the selected animal mode to the white blood cell counting chamber at least once; magnifying volume differences among at least two types of the white blood cells in the sample by controlling a temperature of a liquid, comprising the diluent, the sample and the corresponding hemolytic agent,; and testing the liquid in the white blood cell counting chamber using the impedance method to perform at least four-classification and counting of the white blood cells as cited above, and thus reading in-part on claim 1 and 16. Smith is only missing the limitations towards a user selection of an animal mode and a preset temperature for the selected animal mode for claims 1 and 16, which is fully addressed by the secondary teachings of Lock and Wu as set forth above. Applicant may be alleging that Smith is deficient by being directed to what Applicant considers a nonpreferred embodiment, but this argument is not persuasive of error because a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments; see M.P.E.P. § 2123.
On pages 15-16 of the reply, Applicant alleges that the instant amendments to claims 1 and 16 overcome the obviousness rejection of record. This is not found persuasive because claim scope is not limited by language that simply expresses the intended result of a process step positively recited; see M.P.E.P. § 2111.04. Is this case, the amendments rephrasing the “controlling” step of claims 1 and 16 to a “magnifying” step does not overcome the obviousness rejection of record because Smith as previously and currently cited teaches controlling the temperature of the diluent, the sample, and the hemolytic agent, and so any magnification of volume differences in a least two white blood cells in the sample as claimed is the simple recitation of the intended outcome/result and so is afforded no patentable weight.
In response to applicant's arguments on pages 16-17 of the reply regarding Lock and Wu, these arguments are not found persuasive of error because the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, none of Applicant’s argument’s address the specific rationale of record to combine these references with Smith to render independent claims 1 and 16 and dependent claims , 2, 4, 5, 8, 11, 12, and 17-20 prima facie obvious under 35 U.S.C. § 103.
Conclusion
No claims are allowed. No claims are free of the art.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653