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
Acknowledgement is made of Applicant’s claim of the present application claiming priority and benefit under 35 U.S.C. 119(a-d) to European Patent Application No. EP18162033.7 filed 03/15/2018. Acknowledgement is made of Applicant’s claim of the present application being a divisional of US Patent Application No. 16/980,835 filed 09/14/2020.
Information Disclosure Statement
The information disclosure statement (“IDS”) filed 02/06/2025 was reviewed and the listed references were noted.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the device of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Status of Claims
Claims 1-16 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are rejected on the grounds of non-statutory double patenting as being unpatentable over Claims 1-19 of Patent No. 10,801,944, in view of Hayden et al. (US 2016/0231225 A1).
The following is a chart mapping for example independent claim 1 of the instant application to claim 1 of Patent No. 10,801,944.
Instant Application
Patent No. 10,801,944
A cell analysis device configured to carry out a method for determining a cell type of a white blood cell in a biological sample without labeling, the cell analysis device comprising a microcontroller configured to:
cause microscopy apparatus to image the white blood cell;
and determine the cell type of the white blood cell
A method for marker-free detection of a cell type of at least one cell in a medium, comprising: flowing a medium comprising at least one cell into a microfluidic device, obtaining an image of the at least one cell in the microfluidic device by a digital holographic microscopic device, wherein the image is obtained with a depth of field of less than 6 μm, and determining the cell type of the at least one cell.
(Claims 8, 9, and 12 of Patent No. 10,801,944 claim determining the cell type of the white blood cell)
Regarding claim 1, the claim 1 of Patent No. 10,801,944 does not explicitly teach, “ascertain physical parameters of the white blood cell from an image of the white blood cell;” and “based on the physical parameters and principal component analysis parameters, wherein the principal component analysis parameters comprise linear combinations of at least some of the physical parameters”. Since Patent No. 10,801,944 does not explicitly disclose these limitations, Examiner relies on the teachings of Hayden in an analogous field of endeavor. Specifically, Hayden teaches, “ascertain physical parameters of the white blood cell from an image of the white blood cell;” (Hayden, Para. [0032] discloses; “In a further embodiment of the inventive method the quantitative cell feature can describe, for example, a cell volume, a volume of the cell compartment, a cell area, an area of the cell compartment, a ratio of a cell volume to a cell nucleus volume, a ratio of a cell area to a cell nucleus area, a diameter of the cell compartment, a roundness of the cell compartment, a circumference of the cell compartment, a number of the cell compartment and/or a statistical feature of a cell feature which is determined using the respective height profile of a plurality of cells and/or using the height profiles of a plurality of cell compartments.”) “based on the physical parameters and principal component analysis parameters, wherein the principal component analysis parameters comprise linear combinations of at least some of the physical parameters” (Hayden, Para. [0037] discloses; “The cell type of the cell is preferably determined in a first classification step of the cell using the combination of the number of cell compartments and the ratio of the cell area and the area of the cell compartment and in a further classification step using the combination of a variance in the diameter of the cell compartment and a mean diameter of the cell compartment.”)
Patent No. 10,801,944 and Hayden are considered to be analogous to the claimed invention because they are in the same field of imaging and classifying different white blood cells without labeling. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent No. 10,801,944 to incorporate the teachings of Hayden in order to classify cells based on their physical parameters. One of ordinary skill in the art would have been motivated to combine the previously described device of Patent No. 10,801,944 with the teachings of Hayden to increase the classifying accuracy by taking the physical properties of the cell into account. Accordingly, it would have been obvious to combine Patent No. 10,801,944 and Hayden to obtain the above specified limitations. Additionally, claims 2-16 are rejected under non-statutory obviousness-type double patenting in the same manner and rationale as claim 1, with the corresponding references as disclosed below in the 102 and 103 rejections.
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 non-statutory subject matter (an abstract idea without significantly more). The claims recite an apparatus for processing images of white blood cells, and classifying them by their physical parameters. With respect to analysis of Claim 1:
Step 1:
With regard to Step 1, the instant claim is directed to an apparatus; and therefore, the claim is directed to one of the statutory categories of inventions.
Step 2A, Prong One:
With regard to 2A, Prong One, the limitations of “ascertain physical parameters of the white blood cell from an image of the white blood cell; and determine the cell type of the white blood cell based on the physical parameters and principal component analysis parameters, wherein the principal component analysis parameters comprise linear combinations of at least some of the physical parameters”, as drafted, recite an abstract idea, such as the combination of an apparatus and using mathematical calculations/measurements that, under their broadest reasonable interpretation, covers the performance of the limitation manually, or in the mind of a medical professional. That is, a skilled technician or a doctor may be able to measure different parameters of cells within an image, and make a determination/judgement on the type of cells in the image. This is the concept that falls under the combination of the groupings of abstract ideas of mental processes and mathematical calculations/measurements, i.e., a concept performed in the human mind, evaluation, judgement, and/or opinion of a technician/doctor through mathematical calculations to obtain a classification for a cell.
Step 2A, Prong Two:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception. In the instant case, there are no additional elements/limitations in the claims, with the exception of the insignificant extra-solution activities, such as obtaining an image of the cells. This limitation is regarded as insignificant extra-solution activity of acquiring medical image data, i.e., gathering input information, which may not be considered as an indication of integration of the judicial exception into a practical application. Accordingly, the above-mentioned additional element/limitation does not integrate the abstract idea into a practical application; and therefore, the claim recites an abstract idea.
Step 2B:
Because the claims fail under Step 2A, the claims are further evaluated under Step 2B. The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because as discussed above with respect to integration of the abstract idea into practical application, the additional elements/limitations, amount to no more than insignificant routine and conventional elements. The abstract operation/purpose of the apparatus as listed in Claim 1, cannot provide an inventive concept. Therefore, independent Claim 1 is not patent eligible.
Furthermore, with regard to dependent claims 2-16, viewed individually, these additional elements/limitations, under their broadest reasonable interpretation, are regarded as either providing additional abstract idea (i.e., mathematical calculations or performing the limitations in the mind of a medical technician) or adding limitations that may not be considered as significantly more than the abstract idea; which do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Accordingly, they are not patent eligible.
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 1-3, 6, 7, 10, 13, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayden et al. (US 2016/0231225 A1).
Regarding claim 1, Hayden teaches, “A cell analysis device configured to carry out a method for determining a cell type of a white blood cell in a biological sample without labeling, the cell analysis device comprising a microcontroller configured to:” (Hayden, Abstract discloses; “An in vitro method for the marker-free determination of a cell type of a cell in a biological sample is disclosed, a microscopic device being configured to detect a height profile of the cell with respect to a carrier plate.”) “cause microscopy apparatus to image the white blood cell;” (Hayden, Para. [0034] discloses; “For example, the mean diameter of the cell nucleus of a large number of, for example, white blood cells as cells can be related to the diameter of the cell nucleus of the cell being examined.”) “ascertain physical parameters of the white blood cell from an image of the white blood cell;” (Hayden, Para. [0032] discloses; “In a further embodiment of the inventive method the quantitative cell feature can describe, for example, a cell volume, a volume of the cell compartment, a cell area, an area of the cell compartment, a ratio of a cell volume to a cell nucleus volume, a ratio of a cell area to a cell nucleus area, a diameter of the cell compartment, a roundness of the cell compartment, a circumference of the cell compartment, a number of the cell compartment and/or a statistical feature of a cell feature which is determined using the respective height profile of a plurality of cells and/or using the height profiles of a plurality of cell compartments.”) “and determine the cell type of the white blood cell based on the physical parameters and principal component analysis parameters, wherein the principal component analysis parameters comprise linear combinations of at least some of the physical parameters.” (Hayden, Para. [0037] discloses; “The cell type of the cell is preferably determined in a first classification step of the cell using the combination of the number of cell compartments and the ratio of the cell area and the area of the cell compartment and in a further classification step using the combination of a variance in the diameter of the cell compartment and a mean diameter of the cell compartment.”)
Regarding claim 2, Hayden teaches, “A microscopy apparatus for determining a cell type of a cell of a biological sample without labeling, comprising the cell analysis device of claim 1 and at least one of a light microscope, a scanning electron microscope, a phase contrast microscope, a digital holographic microscope, or a microscope with an ultrasonic sensor.” (Hayden, Para. [0009] discloses; “A microscopy device is a device with which very small objects can be viewed greatly enlarged and comprises, for example, a light microscope, a scanning electron microscope, a phase contrast microscope, a digital holographic microscope or a microscope having an ultrasound sensor (for example an acoustic microscope).”)
Regarding claim 3, Hayden teaches, “The cell analysis device of claim 1, wherein a determined cell type of the white blood cell is a principal type of white blood cell selected from the group consisting of monocytes, neutrophils, basophils, eosinophils, and lymphocytes” (Hayden, Para. [0043] discloses; “In a further embodiment the cell type can be determined to differentiate neutrophils, eosinophils, basophils, lymphocytes and/or monocytes”)
Regarding claim 6, Hayden teaches, “The cell analysis device of claim 1, wherein the physical parameters of the cell comprise parameters selected from the group comprising area covered by the cell, perimeter of the cell, width of the cell, height of the cell, ratio of the width to the height of the cell, similarity of a geometric shape of the cell to a circle, mean radius of the cell, variance of the radius of the cell, degree of coverage of the cell, equivalent diameter corresponding to the covered area of the cell, optical volume of the cell, maximum optical height of the cell, minimum optical height of the cell, mean optical height of the cell, variance of the optical height of the cell, biconcavity of the cell, sphericity of the cell, shift of a center of mass of the cell, contrast of the cell, dissimilarity of the cell, homogeneity of the cell, energy of the cell, and entropy of the cell.” (Hayden, Para. [0032] discloses; “In a further embodiment of the inventive method the quantitative cell feature can describe, for example, a cell volume, a volume of the cell compartment, a cell area, an area of the cell compartment, a ratio of a cell volume to a cell nucleus volume, a ratio of a cell area to a cell nucleus area, a diameter of the cell compartment, a roundness of the cell compartment, a circumference of the cell compartment, a number of the cell compartment and/or a statistical feature of a cell feature which is determined using the respective height profile of a plurality of cells and/or using the height profiles of a plurality of cell compartments.”)
Regarding claim 7, Hayden teaches, “The cell analysis device of claim 1, wherein the microcontroller is further configured to cause the microscopy apparatus to image the white blood cell by overlaying a reference wave on an object wave and recording a resultant interferogram or computer-implemented mathematical reconstruction.” (Hayden, Para. [0038] discloses; “The height profile is preferably detected by superimposing a reference wave on an object wave, recording a resulting interferogram and/or a mathematical reconstruction”)
Regarding claim 10, Hayden teaches, “The cell analysis device of claim 1, wherein the microcontroller is further configured to cause the microscopy apparatus to image a non-stained or non-desiccated white blood cell.” (Hayden, Para. [0009] discloses; “At least one embodiment of the invention is directed to an inventive in vitro method for the marker-free determination of a cell type of a cell in a biological sample is carried out with the aid of a microscopy device and a cell analysis device.” and Hayden, Para. [0037] discloses; “This embodiment of the inventive method proves itself in particular with complicated cell suspensions analyses, for example with a differential blood count, in which, for example, white blood cells are differentiated”)
Regarding claim 13, Hayden teaches, “The cell analysis device of claim 1, wherein the microcontroller is further configured to cause the microscopy apparatus to phenotype the white blood cell with a label.” (Hayden, Para. [0041] discloses; “According to a further example embodiment the inventive method can comprise phenotyping of the cell with a marker and/or expressing a predetermined receptor for further allocation of the cell.”)
Regarding claim 14, Hayden teaches, “The cell analysis device of claim 1, wherein the biological sample contains blood cells, monocytes, neutrophils, basophils, eosinophils, or lymphocytes.” (Hayden, Para. [0042] discloses; “At least one embodiment of the inventive method obtains particular relevance if it is carried out according to a further embodiment using a whole blood sample and/or the biological sample comprises blood cells, leucocytes, eosinophilic and/or basophilic leucocytes.”)
Regarding claim 16, Hayden teaches, “The cell analysis device of claim 1, wherein the biological sample comprise a whole blood sample.” (Hayden, Para. [0042] discloses; “At least one embodiment of the inventive method obtains particular relevance if it is carried out according to a further embodiment using a whole blood sample and/or the biological sample comprises blood cells, leucocytes, eosinophilic and/or basophilic leucocytes.”)
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hayden et al. (US 2016/0231225 A1), in view of Yoon et al. (“Label-Free Identification of Non-Activated Lymphocytes Using Three-Dimensional Refractive Index Tomography and Machine Learning”).
Regarding claim 4, Hayden does not explicitly teach, “The cell analysis device of claim 3, wherein the determined cell type is one of the principal types of white blood cells and a sub-type of white blood cells selected from the group consisting of myelocytes, metamyelocytes, promyelocytes, blasts, megakaryocytes, plasma cells, atypical lymphocytes, and Sézary cells”. Since Hayden does not explicitly disclose these limitations, Examiner relies on the teachings of Yoon in an analogous field of endeavor. Specifically, Yoon teaches, “The cell analysis device of claim 3, wherein the determined cell type is one of the principal types of white blood cells and a sub-type of white blood cells selected from the group consisting of myelocytes, metamyelocytes, promyelocytes, blasts, megakaryocytes, plasma cells, atypical lymphocytes, and Sézary cells” (Yoon, Page 1, Para. 1 discloses; “We show that our approach enables label-free identification of three lymphocyte cell types (B, CD4+ T, and CD8+ T lymphocytes) with high specificity and sensitivity.” Examiner interprets the CD4 + lymphocytes to be Sézary cells)
Hayden and Yoon are considered to be analogous to the claimed invention because they are in the same field of imaging and classifying different white blood cells without labeling. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayden to incorporate the teachings of Yoon in order to further classify cells into their sub-sets. One of ordinary skill in the art would have been motivated to combine the previously described device of Hayden with the teachings of Yoon to increase the classifying capabilities of the device. Accordingly, it would have been obvious to combine Hayden and Yoon to obtain the above specified limitations.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hayden et al. (US 2016/0231225 A1), in view of Vanna et al. (“Label-Free Imaging and Identification of Typical Cells of Acute Myeloid Leukemia and Myelodysplastic Syndrome by Raman Microspectroscopy”).
Regarding claim 5, Hayden teaches, “The cell analysis device of claim 1, wherein the microcontroller is further configured to: characterize respective cell populations based on determining respective cell type of a multiplicity of white blood cells;” (Hayden, Para. [0003] discloses; “Determination of the number of leucocytes (white blood count, WBC) should be able to differentiate the essential populations of the white blood cells for a comprehensive diagnosis.”) Hayden does not explicitly teach, “and determine whether acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML) or chronic lymphocytic leukemia (CLL) is present in a patient from whom the biological sample originated based on the characterized cell populations.” Since Hayden does not explicitly disclose these limitations, Examiner relies on the teachings of Vanna in an analogous field of endeavor. Specifically, Vanna teaches, “and determine whether acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML) or chronic lymphocytic leukemia (CLL) is present in a patient from whom the biological sample originated based on the characterized cell populations.” (Vanna, Abstract discloses; “Here we have used Raman spectroscopy for distinguishing myeloblasts, promyelocytes, abnormal promyelocytes and erhytroblasts, which have to be counted for a correct diagnosis and morphological classification of AML and MDS.”)
Hayden and Vanna are considered to be analogous to the claimed invention because they are in the same field of imaging and classifying different white blood cells without labeling. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayden to incorporate the teachings of Vanna in order to identify a type of leukemia associated with the number of classified cells. One of ordinary skill in the art would have been motivated to combine the previously described device of Hayden with the teachings of Vanna to give a diagnosis of a patient to the user based on cell populations. Accordingly, it would have been obvious to combine Hayden and Vanna to obtain the above specified limitations.
Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hayden et al. (US 2016/0231225 A1), in view of Moore et al. (US 2004/0070757 A1).
Regarding claim 8, Hayden does not explicitly teach, “The cell analysis device of claim 1, wherein the microcontroller is further configured to cause the microscopy apparatus to image the white blood cell in a flow cell”. Since Hayden does not explicitly disclose this limitation, Examiner relies on the teachings of Moore in an analogous field of endeavor. Specifically, Moore teaches, “The cell analysis device of claim 1, wherein the microcontroller is further configured to cause the microscopy apparatus to image the white blood cell in a flow cell” (Moore, Para. [0006] discloses; “In a typical flow cytometer, a sheath stream and sample fluid stream (containing suspended particles to be analyzed) are introduced into the flow cell in a pre-analysis section (chamber) of the flow cell. The sheath stream is injected into the flow cell and allowed to flow for a sufficient distance to form a fully developed laminar flow profile. The sample stream is injected into the center of this flow profile. The sample fluid is thus kept centered in the flow channel of the flow cell by the laminar sheath flow that includes a velocity differential between the sheath and the sample streams.” It would be obvious to use the flow cell of Moore to image the white blood cells of Hayden.)
Hayden and Moore are considered to be analogous to the claimed invention because they are in the same field of imaging cells using flow cytometry. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayden to incorporate the teachings of Moore in order to image the cells in a flow cell of a flow cytometry device. One of ordinary skill in the art would have been motivated to combine the previously described device of Hayden with the teachings of Moore to quickly analyze characteristics of multiple cells as they pass through the flow cell. Accordingly, it would have been obvious to combine Hayden and Moore to obtain the above specified limitations.
Regarding claim 11, the combination of Hayden and Moore teaches, “The cell analysis device of claim 1, wherein the microcontroller is further configured to cause the microscopy apparatus to image the white blood cell focused by laminar sheath flows” (Moore, Para. [0006] discloses; “The sample fluid is thus kept centered in the flow channel of the flow cell by the laminar sheath flow that includes a velocity differential between the sheath and the sample streams.”) The proposed combination as well as the motivation for combining the Hayden and Moore references presented in the rejection of claim 8 apply to claim 11 and are incorporated herein by reference. Thus, the device recited in claim 11 is met by Hayden and Moore.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hayden et al. (US 2016/0231225 A1), in view of Moore et al. (US 2004/0070757 A1), in further view of Sundararajan et al. (“Three-Dimensional Hydrodynamic Focusing in Polydimethylsiloxane (PDMS) Microchannels”).
Regarding claim 9, the combination of Hayden and Moore does not explicitly teach, “The cell analysis device of claim 8, wherein the flow cell comprises a channel with a rectangular or square cross-section.” Since the combination of Hayden and Moore does not explicitly disclose these limitations, Examiner relies on the teachings of Sundararajan in an analogous field of endeavor. Specifically, Sundararajan teaches, “The cell analysis device of claim 8, wherein the flow cell comprises a channel with a rectangular or square cross-section.” (Sundararajan, Figure 7 caption discloses; “Cross-sectional profiles clearly indicate a rectangular profile with no confinement in the vertical dimension.”)
Hayden, Moore, and Sundararajan are considered to be analogous to the claimed invention because they are in the same field of imaging cells using flow cytometry. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayden and Moore to incorporate the teachings of Sundararajan in order to ensure the flow cell comprises a channel with a rectangular cross-section. One of ordinary skill in the art would have been motivated to combine the previously described device of Hayden and Moore with the teachings of Sundararajan to easily view the sample in a rectangular format. Accordingly, it would have been obvious to combine Hayden, Moore, and Sundararajan to obtain the above specified limitations.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hayden et al. (US 2016/0231225 A1), in view of Sundararajan et al. (“Three-Dimensional Hydrodynamic Focusing in Polydimethylsiloxane (PDMS) Microchannels”).
Regarding claim 12, Hayden does not explicitly teach, “The cell analysis device of claim 1, wherein the microcontroller is further configured to cause the microscopy apparatus to image the white blood cell focused by four laminar sheath flows.” Since Hayden does not explicitly disclose this limitation, Examiner relies on the teachings of Sundararajan in an analogous filed of endeavor. Specifically, Sundararajan teaches, “The cell analysis device of claim 1, wherein the microcontroller is further configured to cause the microscopy apparatus to image the white blood cell focused by four laminar sheath flows.” (Sundararajan, Figure 8, “Design 1” shows a design for a flow cytometry device with 4 sheath flows. Sundararajan, Page 11, Section 2 discloses; “The flows in the microchannels were always laminar and there was no turbulence or mixing in the microchannels.”)
Hayden and Sundararajan are considered to be analogous to the claimed invention because they are in the same field of imaging cells using flow cytometry. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayden to incorporate the teachings of Sundararajan in order to have 4 different laminar sheath flows. One of ordinary skill in the art would have been motivated to combine the previously described device of Hayden with the teachings of Sundararajan to (Sundararajan, Page 2, Para. 2; “constrain the sample flow to the center of the channel in both the lateral and vertical dimensions”). Accordingly, it would have been obvious to combine Hayden and Sundararajan to obtain the above specified limitations.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hayden at al. (US 2016/0231225 A1), in view of Chow et al. (“Whole Blood Fixation and Permeabilization Protocol with Red Blood Cell Lysis for Flow Cytometry of Intracellular Phosphorylated Epitopes in Leukocyte Subpopulations”)
Regarding claim 15, Hayden does not explicitly teach, “The cell analysis device of claim 1, wherein the biological sample has red blood cells removed using selective lysis before the microscopy apparatus images the white blood cell.” Since Hayden does not explicitly disclose this limitation, Examiner relies on the teachings of Chow in an analogous field of endeavor. Specifically, Chow teaches, “The cell analysis device of claim 1, wherein the biological sample has red blood cells removed using selective lysis before the microscopy apparatus images the white blood cell.” (Chow, Abstract discloses; “Previous studies of intracellular expression of phospho-epitopes in human leukocytes using flow cytometry have used erythrocyte removal or lysis before fixation.”)
Hayden and Chow are considered to be analogous to the claimed invention because they are in the same field of imaging cells using flow cytometry. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayden to incorporate the teachings of Chow in order to perform red blood cell lysis. One of ordinary skill in the art would have been motivated to combine the previously described device of Hayden with the teachings of Chow to remove the red blood cells so they are not a part of the imaging process. Accordingly, it would have been obvious to combine Hayden and Chow to obtain the above specified limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN M. OAKES whose telephone number is (571)272-9379. The examiner can normally be reached 7:30am-5pm.
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/JUSTIN M OAKES/
Examiner, Art Unit 2662
/Siamak Harandi/Primary Examiner, Art Unit 2662
Prosecution Insights