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 .
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group I, claims 1, 5-10, 12, 14-16, 20-25, and 28, filed March 23, 2026 is acknowledged and has been entered. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 31 and 32 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention. Accordingly, claims 1, 5-10, 12, 14-16, 20-25, 28, 31, and 32 are pending. Claims 1, 5-10, 12, 14-16, 20-25, and 28 are under examination.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a 371 National Stage application of PCT/IB2021/053301 filed 04/21/2021, which claims the benefit of Provisional Application Number 63/013,098 filed 4/21/2020. Based on the filing receipt, the effective filing date of this application is April 21, 2020 which is the filing date of Provisional Application Number 63/013,098 from which the benefit of domestic priority is claimed.
Specification
3. The use of the terms DAPI, DRAQ-7, 7-AAD, and TO-PRO and others, which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
4. Claim 16, in step e. is objected to in reciting “a fluorescence measurement for each a dilution sample.” It should recite “a fluorescence measurement for each dilution sample. 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.
5. Claims 1, 5-10, 12, 14, 15, 20, 23, and 24 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.
Claim 1, step b) lacks clear antecedent basis in reciting “the specific antibody conjugated to the fluorochrome” because step a) recites the fluorochrome as being conjugated to the non-specific antibody.” Perhaps, Applicant intends, “the specific antibody capable of specifically binding to the target marker of the target cell and conjugated to the fluorochrome of a (ii).
Claim 5 recites improper Markush language in reciting “wherein the fluorescent dead cell exclusion dye is selected from … and ….” Perhaps, Applicant intends “wherein the fluorescent dead cell exclusion dye is selected from the group consisting of … and ….”
Claim 5 contains the trademark/trade names “DAPI”, “DRAQ-7”, “7-AAD”, and “TO-PRO.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Exparte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. Accordingly, claim 5 is indefinite.
Claim 8 recites improper Markush language in reciting “wherein the fluorochrome is selected from … , APC-H7….” Perhaps, Applicant intends “wherein the fluorochrome is selected from the group consisting of … , and APC-H7….”
Claim 9 recites improper Markush language in reciting “wherein the target cell marker is selected from … and ….” Perhaps, Applicant intends “wherein the target cell marker is selected from the group consisting of … and ….”
Claim 20 recites improper Markush language in reciting “wherein the fluorescent dead cell exclusion dye is selected from … and ….” Perhaps, Applicant intends “wherein the fluorescent dead cell exclusion dye is selected from the group consisting of … and ….”
Claim 20 contains the trademark/trade names “DAPI”, “DRAQ-7”, “7-AAD”, and “TO-PRO.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Exparte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. Accordingly, claim 20 is indefinite.
Claim 23 recites improper Markush language in reciting “wherein the fluorochrome is selected from … , APC-H7….” Perhaps, Applicant intends “wherein the fluorochrome is selected from the group consisting of … , and APC-H7….”
Claim 24 recites improper Markush language in reciting “wherein the target cell marker is selected from … and ….” Perhaps, Applicant intends “wherein the target cell marker is selected from the group consisting of … and ….”
Allowable Subject Matter
6. Claims 1, 5-10, 12, 14-16, 20-25, and 28 are free of the prior art of record.
7. Claim 1, 5-10, 12, 14-16, 20-25, and 28 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
8. The prior art of record fails to teach or fairly suggest a method for validating measurements by a flow cytometer or cell-based fluorescence analytical instrument of a stained target cell population comprising target cells expressing a target cell marker in a test sample which comprises a) a reference sample I negative staining step; b) a reference sample II positive staining step; c) subjecting (running) each one of the a) negatively stained reference sample 1 and b) the positively stained reference sample 2 to flow cytometry to obtain fluorescence measurements indicative of the target cell concentration in each of the reference sample I and the reference sample II; d) based on the fluorescence measurements in c), diluting the positively stained target cells with the negatively stained target cells to thus obtain a dilution sample having a highest concentration of the target cells from which a series of dilution samples are prepared. The a) reference sample I negative staining step comprises introducing to the reference sample I (i) a fluorescent dead cell exclusion dye, (ii) a non-specific antibody conjugated to a fluorochrome, and (iii) a specific antibody which specifically binds a target marker on the target cell; and the b) reference sample II positive staining step comprises introducing to the reference sample II (i) the fluorescent dead cell exclusion dye and (ii) the specific antibody conjugated to the fluorochrome which specifically binds the target marker on the target cell. The series of dilution samples prepared each has a nominal concentration of the target cells varying systematically across the dilution series: each nominal cell concentration being greater than the concentration of target cells indicated by the fluorescence measurement of the negatively stained reference sample in (a) and differs from the nominal concentration in each of the remaining dilution samples, wherein the highest concentration of the target cells is 2%, 1%,0.5%, 0.2%, 0.1%, 0.05%, or 0.02%. The method further comprises e) running the series of dilution samples from (d) through the flow cytometer to obtain a series of fluorescence measurements for each dilution sample; and f) for each dilution sample, comparing the nominal cell concentration from (d) and the fluorescence measurement from (e) to quantify the performance of the bead-based flow cytometric staining method, by performing a statistical calculation on the difference between the nominal cell concentration and the fluorescence measurement for each dilution sample to determine at least one of linearity, range, accuracy, precision, limit of detection (LOD) and lowest limit of quantification (LLOQ) for the flow cytometer and staining method, wherein the LLOQ is identified by the concentration of target cells associated with a predetermined criterion for precision and a predetermined criterion for accuracy.
9. No claims are allowed.
Remarks
10. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Wood et al. (Validation of Cell-based Fluorescence Assays: Proactive Guidelines from the ICSH and ICCS- Part V- Assay Performance Criteria. Cytometry Part B. Clinical Cytometry 848: 315-323 (2013)) teaches validation requirements and describes validation strategies for quasi-quantitative and qualitative cell-based flow cytometric assays using reference materials (Abstract; p. 316-320).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
April 23, 2026
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