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 .
Status of Claims
Claims 1-16 are pending for examination and are considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see ¶¶ [0096] and [0101] of Applicant’s specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The disclosure is objected to because of the following informalities: (i) “attitude” in paragraph [0197] of Applicant’s specification appears to be a typographical error, and (ii) the text “= missing subheading. Location = suggestion.” to the right of the header “(Sixth Embodiment)” between paragraphs [0333] and [0334] of Applicant’s specification appears to have been inadvertently left in the specification.
Appropriate correction is required.
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 1-16 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.
Regarding claim 1, the limitation “sorting a cell population containing basophils from particles in the measurement sample based on optical information including the first fluorescence information [emphasis added]” is recited. It is unclear whether the sorting in claim 1 is based on (i) the optical information which includes the first fluorescent information, or (ii) the first fluorescent information as a subset of the optical information. For examination purposes, the limitation “sorting a cell population containing basophils from particles in the measurement sample based on optical information including the first fluorescence information,” is interpreted as sorting a cell population containing basophils from particles in the measurement sample based on the first fluorescence information.
Regarding claim 2, the limitation “wherein the optical information including the first fluorescence information is fluorescence intensity of the first fluorescent dye” is recited. It is unclear whether (i) the optical information which includes the first fluorescent information is fluorescence intensity of the first fluorescent dye, or (ii) the first fluorescent information as a subset of the optical information is fluorescence intensity of the first fluorescent dye. For examination purposes, the limitation “wherein the optical information including the first fluorescence information is fluorescence intensity of the first fluorescent dye” is interpreted as the first fluorescence information is fluorescence intensity of the first fluorescent dye.
Regarding claim 3, the limitation “wherein the optical information including the first fluorescence information is a fluorescence intensity and a side scattered light intensity of the first fluorescent dye” is recited. It is unclear whether (i) the optical information which includes the first fluorescent information is fluorescence intensity of the first fluorescent dye, or (ii) the first fluorescent information as a subset of the optical information is a fluorescence intensity and a side scattered light intensity of the first fluorescent dye. For examination purposes, the limitation “wherein the optical information including the first fluorescence information is a fluorescence intensity and a side scattered light intensity of the first fluorescent dye” is interpreted is a fluorescence intensity and a side scattered light intensity of the first fluorescent dye.
Regarding claim 14, the limitations “the result obtained by the classifying into four subpopulations” and “the result obtained by the counting cells classified into the basophil population” are recited. There is insufficient antecedent basis for these limitation in the claim.
Claims 4-13 and 15-16 are also rejected for being dependent on a claims rejected under 35 U.S.C. 112(b).
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1, the claimed invention is directed to an abstract idea without significantly more for the reasons discussed below (see Subject Matter Eligibility Test in MPEP 2106).
Eligibility Step 1: Claim 1 is directed to a method/process.
Eligibility Step 2A, Prong 1: Claim 1 recites the abstract ideas of: (i) classifying white blood cells contained in the cell population into subpopulations based on the second fluorescence information and the scattered light information (classifying white blood cells contained in the cell population into subpopulations is an observation or evaluation that can be practically performed in the human mind); and (ii) counting cells classified as a population of basophils in the subpopulation (counting cells classified as a population of basophils in the subpopulation is a mathematical calculation).
Eligibility Step 2A Prong 2: The judicial exception is not integrated into a particular practical application. Other than the abstract ideas, claim 1 recites steps of preparing, irradiating, and sorting. When considered individually and in combination with the remaining elements of claim 1 as a whole, the steps of preparing, irradiating, and sorting are mere data gathering and hence insignificant extra-solution activity (see MPEP 2016.05(g)). Furthermore, once the counting step is completed, nothing further is done with the abstract ideas. Thus, there is no application of the abstract idea much less a practical particular application.
Eligibility Step 2B: Claim 1 does not recite additional elements that are sufficient to amount to significantly more than the judicial exception. Other than the abstract ideas, claim 1 recites steps of preparing, irradiating, and sorting. As discussed above, the steps of preparing, irradiating, and sorting are insignificant extra-solution activity. Furthermore, the steps of preparing, irradiating, and sorting are well understood, routine and conventional activities within the prior art (see Ye and Khan as applied in the rejection of claim 1 below) (see also MPEP 2106.05(d)).
Dependent claims 2-16 do not resolve any of the issues discussed above because they involve insignificant extra-solution activity and/or well understood, routine and conventional activities within the prior art.
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.
Claims 1-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al. (U.S. Pat. Pub. No. 2021/0041344; hereinafter “Ye”) in view of Khan et al. (U.S. Pat. Pub. No. 2015/0030215; hereinafter “Khan”).
Regarding claim 1, Ye teaches a method for classifying white blood cells into subpopulations (see ¶¶ [0007], [0045], and [0099]), comprising:
preparing a measurement sample by mixing a specimen containing white blood cells (a blood sample, interpreted as the specimen, contains white blood cells; ¶¶ [0022], [0048], [0082], and [0119]), a hemolysis reagent containing a surfactant (a hemolytic agent for lysing red blood cells wherein the hemolytic agent may be any one of a cationic surfactant, a nonionic surfactant, an anionic surfactant and an amphiphilic surfactant or any combination thereof; ¶¶ [0022], [0082], and [0126]), a fluorescent dye (a fluorescence dye for staining white blood cells; ¶¶ [0022], [0082], and [0112]) (wherein the test blood sample is mixed with the hemolytic agent and the fluorescence dye to obtain a first test sample, which is interpreted as the measurement sample; ¶¶ [0022] and [0082]);
irradiating particles in the measurement sample with light (directing, i.e., irradiating, a light beam to an optical flow chamber which contains the first test sample; ¶¶ [0022] and [0083]-[0084]), and detecting optical information including fluorescence information based on fluorescence from the fluorescent dye, and scattered light information (detecting optical signals, which is interpreted as the optical information, including forward scattered light signals, which is interpreted as the scattered light information, and fluorescent signals, which is interpreted as the fluorescence information, of the first test sample; ¶¶ [0022], [0082]-[0084], and [0109]);
sorting a cell population containing basophils from particles in the measurement sample based on optical information including the fluorescence information (classifying, i.e., sorting, white blood cells into basophils from the first test sample based on the scattered light signals and the fluorescent signals; ¶¶ [0008], [0016], [0082], and [0099]);
classifying white blood cells contained in the cell population into subpopulations based on the fluorescence information and the scattered light information (classifying white blood cells in the test sample into neutrophils, lymphocytes, monocytes and eosinophils, which are subpopulations of the white blood cells, based on the scattered light signals and the fluorescent signals; ¶¶ [0008], [0016], [0062], [0084], and [0099]); and
counting cells classified as a population of basophils in the subpopulation (counting basophils; ¶¶ [0008], [0016], and [0099]).
However, Ye does not explicitly teach wherein (i) the step of preparing comprises mixing a second fluorescent dye, (ii) the step of detecting optical information comprises second fluorescence information based on fluorescence from the second fluorescent dye, (iii) the step of sorting a cell population is based on optical information including the first fluorescent information whereas the step of classifying white blood cells is based on the second fluorescence information, and (iv) the second fluorescent dye is a fluorescent dye having maximum absorption in a wavelength range different from that of the first fluorescent dye.
Khan, in the analogous art of methods for the analysis of whole blood samples, teaches colorants (i.e., fluorescent dyes) that differentially identify constituents within a sample (e.g., white blood cells) by absorbing transmittance light or by emitting fluorescent light in response to one or more excitation wavelengths (see ¶ [0036]). Khan further teaches that one or more colorants may be mixed with whole blood and subjected to an excitation wavelength from a fluorescent light source to differentially identify constituents within the sample (e.g., WBCs) (see ¶¶ [0036], [0038], and [0051]). For example, a fluorescent colorant such as Acridine Orange is used to tag white blood cells within a sample (see ¶¶ [0051] and [0057]).
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 step of preparing in Ye by incorporating a second colorant (e.g., Acridine Orange, etc.) as taught by Khan as the first fluorescent dye (in combination with Ye’s dye as the second fluorescent dye), the step of detecting in Ye to include detecting fluorescence information of Khan’s fluorescent dye as the first fluorescent information (in combination with Ye’s dye as the second fluorescent information), the step of sorting a cell population based on the Khan’s dye (e.g., Acridine Orange which identifies WBCs within a sample) (whereas the step of classifying is based on Ye’s dye as the second fluorescent information) for the benefit of identifying multiple constituents within the sample by absorbing different transmittance lights (see ¶¶ [0036] and [0038]). The combination of Ye and Khan teaches wherein the second fluorescent dye is a fluorescent dye having maximum absorption in a wavelength range different from that of the first fluorescent dye (wherein Ye’s fluorescent dye, e.g., M-68FN dye has a maximum absorption in a wavelength range different from that of Khan’s fluorescent dye, e.g., Acridine Orange; Ye, ¶¶ [0167]-[0168], Khan, ¶¶ [0036] and [0051]).
Regarding claim 2, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. Ye in view of Khan further teaches wherein the optical information including the first fluorescence information is fluorescence intensity of the first fluorescent dye (classifying white blood cells by detecting differences in scattered light intensities and fluorescence intensities; Ye, ¶¶ [0082] and [0088]-[0089]), and
in the sorting a cell population, a population of particles having a fluorescence intensity of the first fluorescent dye larger than a predetermined threshold value is sorted (wherein in differentiating, i.e., sorting, white blood cells from red blood cell fragments, fluorescence intensities larger than a preset region P, which is interpreted as a predetermined threshold value, in a scattergram with the intensities of the forward scattered light signals of the first test sample as abscissa and the intensities of the fluorescent signals of the first test sample as ordinate are classified as corresponding to white blood cells; Ye, ¶¶ [0088]-[0089]; Ye, Fig. 2A-2B).
Regarding claim 3, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. Ye in view of Khan further teaches wherein the optical information including the first fluorescence information is a fluorescence intensity and a side scattered light intensity of the first fluorescent dye (classifying white blood cells by detecting differences in scattered light intensities and fluorescence intensities; Ye, ¶¶ [0082] and [0088]-[0089]), and
in the sorting a cell population, a population of particles having appeared in a predetermined region where the fluorescence intensity of the first fluorescent dye is larger than a predetermined threshold value is sorted on a scattergram having the fluorescence intensity and the side scattered light intensity of the first fluorescent dye as two axes (wherein in differentiating, i.e., sorting, white blood cells from red blood cell fragments, fluorescence intensities larger than a preset region P, which is interpreted as a predetermined threshold value, in a scattergram with the intensities of the forward scattered light signals of the first test sample as abscissa and the intensities of the fluorescent signals of the first test sample as ordinate are classified as corresponding to white blood cells; Ye, ¶¶ [0088]-[0089]; Ye, Fig. 2A-2B).
Regarding claim 4, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. Ye further teaches wherein the cell population is a population of white blood cells containing basophils (wherein classifying, i.e., sorting, white blood cells into basophils from the first test sample is interpreted as comprising a cell population of white blood cells containing basophils; ¶¶ [0008], [0016], [0082], and [0099]),
in the classifying white blood cells into subpopulations, the cell population is classified into a population of lymphocytes, a population of monocytes, a population of neutrophils, a population of eosinophils, and a population of basophils (classifying white blood cells in the test sample into neutrophils, lymphocytes, monocytes and eosinophils, which are subpopulations of the white blood cells; ¶¶ [0008], [0016], [0062], [0084], and [0099]).
Regarding claim 5, the combination of Ye and Khan teaches method according to claim 1 as discussed above. Ye further teaches wherein the cell population is a population containing basophils, monocytes, and lymphocytes (wherein classifying white blood cells in the test sample into basophils, monocytes, and lymphocytes is interpreted as comprising a cell population containing basophils, monocytes, and lymphocytes; ¶¶ [0008], [0016], [0062], [0084], [0099], and [0119]), and
in the classifying white blood cells into subpopulations, the cell population is classified into a population of lymphocytes, a population of monocytes, and a population of basophils (neutrophils, lymphocytes, monocytes and eosinophils are classified, basophils are further differentiated; ¶ [0119]).
Regarding claim 6, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. Khan further teaches wherein in the detecting optical information, light of a first wavelength capable of exciting the first fluorescent dye and light of a second wavelength capable of exciting the second fluorescent dye are emitted (using a sample illuminator to produce light at one or more wavelengths that are substantially absorbed by the one or more colorants; ¶¶ [0013], [0038], [0043], and [0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Ye in view of Khan to emit light of first and second wavelengths as taught by Khan for the benefit of gathering information at different wavelengths which can be used to evaluate additional constituents within the sample and/or to increase the accuracy of the analysis (Khan, ¶ [0052]).
Regarding claim 7, the combination of Ye and Khan teaches the method for according to claim 6 as discussed above. Ye and view of Khan further teaches wherein the first wavelength is 315 to 490 nm (an excitation light within the range of about 450-490 nm; Khan, ¶ [0036]), and the second wavelength is 610 to 750 nm (an excitation wavelength of 640 nm; Ye, ¶ [0167]).
Regarding claim 8, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. Khan further teaches wherein in the detecting optical information, light capable of exciting both the first fluorescent dye and the second fluorescent dye is emitted (using a sample illuminator to produce light at one or more wavelengths that are substantially absorbed by the one or more colorants; ¶¶ [0013], [0038], [0043], and [0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Ye in view of Khan to emit light of first and second wavelengths as taught by Khan for the benefit of gathering information at different wavelengths which can be used to evaluate additional constituents within the sample and/or to increase the accuracy of the analysis (Khan, ¶ [0052]).
Regarding claim 9, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. Ye in view of Khan further teaches wherein the first fluorescent dye is a compound having an acridine skeleton (Acridine Orange; Khan, ¶¶ [0036], [0051], and [0057]).
Regarding claim 10, the combination of Ye and Khan teaches the method according to claim 9 as discussed above. Ye in view of Khan further teaches wherein the compound having an acridine skeleton is at least one selected from the group consisting of proflavin, 9-aminoacridine, acridine orange, Acridine Yellow G, acriflavin, Basic Yellow 9, lactic acid ethacridine, Euchrysine GG (Euchrysine GGNX), proflavin hemisulfate, 3,6-bis(dimethylamino)acridine, and 3,6-diamino-2,7,10-trimethyl-acridinium chloride (Acridine Orange; Khan, ¶¶ [0036], [0051], and [0057]).
Regarding claim 12, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. Ye further teaches sorting a cell population containing nucleated cells from particles in the measurement sample based on the first fluorescence information between the detecting optical information and the sorting a cell population (wherein nucleated red blood cells are classified and counted at step S506 and white blood cells are classified into white blood cell subpopulations at step S507;¶¶ [0082], [0099], and [0149]).
Claims 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ye in view of Khan as applied to claim 1 above, and further in view of Mizukami et al. (U.S. Pat. No. 6,004,816, listed on an Information Disclosure Statement; hereinafter “Mizukami”).
Regarding claim 11, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. However, Ye in view of Khan does not explicitly teach wherein
the second fluorescent dye is a compound represented by the following formula (V):
[Chemical Formula 1]
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198
572
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wherein R1 and R4 are a hydrogen atom, a methyl group, an ethyl group, or an alkyl group having 6 to 18 carbon atoms, and when one of R1 and R4 is an alkyl group having 6 to 18 carbon atoms, the other is a hydrogen atom, a methyl group, or an ethyl group; R2 and R3 are the same as or different from each other, and R2 and R3 are a methyl group, an ethyl group, a methoxy group, or an ethoxy group; Z is a sulfur atom, an oxygen atom, or a carbon atom having a methyl group; n is 0, 1, 2, or 3; and X- is an anion.
Mizukami, in the analogous art of classification and counting of leukocytes, teaches that leukocytes can be classified into at least 5 populations by the use of a dye having the following structural formula:
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218
552
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where R1 is a hydrogen atom or an alkyl group, R2 and R3 each represent a hydrogen atom, a lower alkyl group or a lower alkoxy group, R4 represents a hydrogen atom, an acyl group or an alkyl group, Z represents a sulfur atom, an oxygen atom, or a carbon atom having a lower alkyl group, n denotes 0, 1 or 2, and X- represents an anion (see col. 2, ll. 14-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the second fluorescent dye of Ye with the dye taught in Mizukami because both dyes were known equivalents for classifying white blood cells. See MPEP 2143(I)(B). The substitution would have resulted in the predictable result of classifying white blood cells.
Regarding claim 15, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. Ye further teaches wherein the hemolysis reagent is a reagent for hemolyzing red blood cells (see ¶¶ [0022] and [0048]). However, Ye in view of Khan does not explicitly teach wherein the hemolysis reagent is a reagent for damaging a cell membrane of white blood cells to such an extent that the first fluorescent dye and the second fluorescent dye can transmit therethrough.
Mizukami, in the analogous art of classification and counting of leukocytes, teaches a hemolytic agent that lyses erythrocytes in the blood sample and forms pores in the cell membrane of a leukocyte cell to be measured, the pores being of a sufficient size for at least dye molecules to pass through (see col. 3, ll. 17-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the hemolysis reagent of Ye with the hemolytic agent taught in Mizukami because both hemolytic agents were known equivalents for hemolyzing red blood cells. See MPEP 2143(I)(B). The substitution would have resulted in the predictable result of hemolyzing red blood cells.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ye in view of Khan as applied to claim 1 above, and further in view of Kimura (U.S. Pat. Pub. No. 2018/0356328).
Regarding claim 13, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. However, Ye in view of Khan does not explicitly teach between the detecting optical information and the sorting a cell population, classifying particles in the measurement sample into four subpopulations of a lymphocyte population, a monocyte population, an eosinophil population, and a population containing both neutrophils and basophils based on the second fluorescence information and the scattered light information.
Kimura, in the analogous art of particle analysis, teaches classifying particles in the measurement sample into four subpopulations of a lymphocyte population, a monocyte population, an eosinophil population, and a population containing both neutrophils and basophils based on fluorescence information and scattered light information (see ¶ [0066]). 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 method of Ye in view of Khan to further classify particles into four subpopulations as taught by Kimura for the benefit of initially inspecting a patient complaining of fever symptoms through use of white blood cells counts within the four classifications (see ¶ Kimura, [0009]).
However, Ye in view of Khan and Kimura does not explicitly teach that the classifying step is between the detecting optical information and the sorting a cell population steps. Nonetheless, 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 process of Ye in view of Khan and Kimura to perform the classifying step between the detecting optical information and the sorting a cell population steps as a mere engineering design choice in which no apparent new or unexpected result is obtained by the order of the process steps. See MPEP 2144.04(IV)(C); see also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
Regarding claim 14, the combination of Ye, Khan, and Kimura teaches the method according to claim 13 as discussed above. Ye in view of Khan and Kimura further teaches the classifying particles in the measurement sample into five subpopulations of a lymphocyte population, a monocyte population, an eosinophil population, a neutrophil population, and a basophil population based on the result obtained by the classifying into four subpopulations and the result obtained by the counting cells classified into the basophil population (wherein Ye’s five subpopulation classification step would be performed after the four subpopulation classification step of Ye in view of Khan and Kimura; Ye, ¶¶ [0099], [0119], [0123], and [0136]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ye in view of Khan as applied to claim 1 above and as further evidenced by Ting et al. (U.S. Pat. No. 8,367,358, listed on an Information Disclosure Statement; hereinafter “Ting”).
Regarding claim 16, the combination of Ye and Khan teaches the method according to claim 1 as discussed above. Ye further teaches wherein the hemolysis reagent is the lytic reagent disclosed in Ting which comprises a nonionic surfactant (see ¶ [0082]). Ting teaches reagents comprising, as a surfactant, a nonionic surfactant represented by the following formula (I):
R1-R2-(CH2CH2O)n-H (I)
wherein R1 is an alkyl group, an alkenyl group or an alkynyl group having 8 or more and 25 or less carbon atoms; R2 represents an oxygen atom, -(COO)- or a group represented by the following formula (II):
[Chemical Formula 2]
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98
284
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and; n is 23 or more and 25 or less, or 30 (see col. 15, ll. 10-40).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven R. Castaneda whose telephone number is (571)272-0998. The examiner can normally be reached Monday through Friday 10am - 6pm ET.
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/STEVEN RAY CASTANEDA/ Examiner, Art Unit 1797
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797