Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/27/2026 and 02/24/2026 have been entered.
Claims 1-15 are pending in the application. Claims 1-6 and 12-15 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/13/2025.
4. Claims 7-11 have been examined.
Grounds of Objection and Rejection Withdrawn
Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 11/24/2025.
Grounds of Rejection Maintained
Double Patenting
6. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
7. Claims 7-11 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,567,081. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 7-11 are herein drawn to a kit for isolating or capturing a circulating tumor cell in a biological sample, the kit comprising:(1) a capture agent comprising an antibody specifically binding at least one epithelial-mesenchymal transition (EMT) biomarker; and (2) at least one staining reagent for confirming the capture of the circulating tumor cell, wherein the at least one staining reagent comprises a detectably labeled β-catenin antibody, wherein the detectably labeled β-catenin antibody allows detection of β-catenin expression on an intact cell to determine whether the intact cell is a circulating tumor cell.
Claims 1-19 of U.S. Patent No. 11,567,081 are drawn to a kit for isolating or capturing a circulating tumor cell in a biological sample, the kit comprising: an antibody linked to a magnetic particle, wherein the antibody binds specifically to at least one epithelial-mesenchymal transition (EMT) biomarker; and a detectably labelled anti-β-catenin antibody and a detectably labelled anti-CD31 antibody, wherein the detectably labelled anti-β-catenin antibody and the detectably labelled anti-CD31 antibody allow detection of β-catenin and CD31 on an intact cell to determine whether the intact cell is a circulating tumor cell.
The Applicant’s arguments:
The claims of U.S. Patent No. 11,567,081 require "an antibody linked to a magnetic particle," while the present claims do not.
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
Given the comprising language of the instant claim 7, the antibody of the patent meets the limitations of the instant claimed antibody. Therefore, the rejection is maintained for the reasons of record.
Conclusion
8. No claim is allowed.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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