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 .
Applicant’s election without traverse of Group I, claims 1-14, in the reply filed on 18 December 2025 is acknowledged. Applicant's election with traverse of the species of CD34 is also acknowledged. Upon further search and consideration, the species of CD3, including claim 5, is rejoined and examined on the merits. Claims 15-19 have been withdrawn. Claims 1-14 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/US2021/041123, filed July 9, 2021, which claims priority to U.S. Provisional Application No. 63/050637, filed July 10, 2020.
Claim Objections
Claim 8 objected to because of the following informalities: the abbreviations for the reagents “FITC,” “PE,” and “PC7” should first be shown with the full term present. Appropriate correction is required.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bari et al. (IDS; US 2019/0359941; Published Nov. 28, 2019), as evidenced by Beckman Coulter, Inc. (Cytomics FC 500 with CXP Software, Instructions for Use, (Dec. 2009), available online at: qb3.berkeley.edu/wp-content/uploads/2020/07/FC500_Manual_Instructions-for-Use.pdf).
With regard to claims 1, 6, and 11, Bari et al. teach a flow cytometry method for the analysis and counting of cells, including hematopoietic stem and progenitor cells and cells that are CD3+ and CD45+ (Abs.; Para. 221), which include T-cells. The method including using a Cytomics FC500 Flow Cytometer and CXP Analysis Software (Beckman Coulter, USA), to analyze an umbilical cord blood or peripheral blood sample, wherein the sample is treated with an imaging reagent comprising recognition elements for CD3, CD34, and CD45 (claim 1; Para. 221-223), which are recognition elements specific for markers on hematopoietic stem cells, hematopoietic progenitor cells, and T-cells. The Cytomics FC500 Flow Cytometer system taught for use in the method of Bari et al. uses sample tubes placed into a carousel (see Beckman Coulter, Inc., p. 1-13 to 1-14), wherein the sample tubes and carousel are a receptacle sample plate and sample preparation area of the flow cytometer.
While a specific step of incubating is not taught, it is taught that the blood sample and imaging reagent comprising the recognition elements for specific markers are brought into contact, where the method provides for the successful analysis of cells from the sample (Para. 222-226). As such, it would have been obvious to an ordinary artisan to incubate the sample with the taught reagent for a time sufficient to provide for the taught analysis. It is further taught that the blood sample is exposed to a lysing reagent to lyse red blood cells in the sample (para. 224-225). The prepared blood sample is analyzed by flow cytometry to obtain counts of viable and total cells that are CD3+, CD34+, and CD45+ (Abs.; Para. 217-218, 222-223), which are hematopoietic stem cells, hematopoietic progenitor cells, and T-cells.
As Bari et al. render obvious the steps as claimed, including the components as claimed, it would have been routine for one of ordinary skill in the art to utilize the taught steps in an order that provides for the most accurate results depending on the specific blood sample analyzed and desired reagents utilized in each step. Bari et al. teach that cells may be counted using an automated differential hematology cell counter (Para. 217). As such, the method is deemed to be an automated flow cytometric method. Further, as Bari et al. render obvious the method as claimed, including the components as claimed, the method is necessarily an automated flow cytometry method.
With regard to claim 2, Bari et al. render obvious the method as claimed, including the components as claimed. As such, the duplication of the method with additional blood samples would have been obvious to an ordinary artisan desiring to confirm the analysis.
With regard to claims 3-5, Bari et al. teach the use of a reference compound, reference vehicle, and blank control when performing cytometric analysis on the cells with reference markers including CD34 and CD3 (Para. 70, 71, 73, 74, 76, 79, 221; Figs. 8-13, 17), which is conducting the method with a negative control, wherein the negative control is for CD34 or CD3.
With regard to claims 7 and 8 Bari et al. teach that the imaging reagent comprises an FITC or PE fluorescent reporter (Para. 222-223).
With regard to claims 9 and 10 Bari et al. teach the composition comprising the imaging reagent further comprises a viability dye, including 7-aminoactinomycin D (7- AAD) (Para. 222-223).
With regard to claim 12, Bari et al. teach that the method includes performing flow cytometry using a Cytomics FC500 Flow Cytometer (Beckman Coulter, USA), wherein the Cytomics FC500 Flow Cytometer system taught for use in the method of Bari et al. uses 12 x 75 mm tubes and 24 or 96-well plates for sample analysis (see Art of Record: American Laboratory Trading, p. 3). As Bari et al. teach that the Cytomics FC500 Flow Cytometer is used to perform the method, it would have been obvious to an ordinary artisan to utilize one of the sample tray options usable with the system, including a 96-well microtiter plate.
Claims 1, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bari et al., as evidenced by Beckman Coulter, Inc., as applied to claim 1 above, and further in view of Rodriguez et al. (IDS; US 6,228,652; Published 2001).
The teaching of Bari et al. as applied to claim 1 have been set forth above.
With regard to claims 13 and 14, Bari et al. do not specifically teach that treating the receptacles with the reagent is performed by an automated pipettor configured to deliver predetermined volumes of the reagent; or that incubating is automated.
Rodriguez et al. teach the use of an automated system for analyzing cells in a whole blood sample (Col. 4, line 19-24). The sample is prepared for analysis in the automated system using a plurality of mixing chambers, where a fluorescent stain is injected into the mixing chamber with the sample in a metered volume (Fig. 2; Col. 11, line 46 to Col. 12, line 2), which is using an automated pipettor to deliver predetermined volumes of reagent. Additionally, incubation for the sample and reagent mixture is automated and conducted for a predetermined period of time (Col. 13, line 14-33).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Bari et al. with Rodriguez et al., because both teach analyzing cells in a blood sample. The use of an automated system for performing analysis of cells in a blood sample, including using an automated pipettor to deliver predetermined volumes of reagent to the sample, and providing automated incubation of the sample with a reagent for a predetermined period of time, is known in the art as taught by Rodriguez et al. The use of automation as taught by Rodriguez et al. would have been expected to predictably and successfully improve the method of Bari et al., by providing an automated system capable of performing the method. Thus, making the method more efficient by eliminating the need for a person to perform each step of the method.
Conclusion
No claims are allowable.
Art of Record:
American Laboratory Trading, Beckman Coulter Cytomics FC500 MPL Flow Cytometer, Accessed: 4/18/2026; Available online at: americanlaboratorytrading.com/lab-equipment-products/beckman-coulter-cytomics-fc-500-mpl-flow-cytometer-19402/?srsltid=AfmBOoq BaRlYK90dI1GYer8aj4ADf-YkOX7neaWTksWRbJQlu1qru9ly (Cytomics FC500 Flow Cytometer system uses 12 x 75 mm tubes and 24 or 96-well plates for sample analysis).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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