Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
2. The amendment filed 10/07/2025 is acknowledged and has been entered.
Claims 7 and 9 have been amended. New claim 16 has been added.
Claims 1-16 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 Claims 1-6 and 12-15 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 and 16 have been examined.
Grounds of Objection and Rejection Withdrawn
5. 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 07/07/2025.
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 and 16 remain/are 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 and 16 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 β-catenin antibody.
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:
Applicants request that the rejection be held in abeyance and respectfully defer addressing this issue until at least some claims are found allowable, at which point Applicants will consider filing a terminal disclaimer.
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
Applicant has not filled an appropriate terminal disclaimer or overcome the rejection by a specific amendment or argument; thus, the rejection is maintained for the reasons of record.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
8. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
9. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
10. Claims 7-11 and 16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Garcia-blanco et al. (WO 2011/093927, published on August 4, 2011, IDS) in view of Scatena et al. (Biochimica et Biophysica Acta, 2013, 1835: 129–143, available online 7 December 2012, IDS).
Claims 7-11 and 16 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 β-catenin antibody.
Garcia-blanco et al. teach a kit for detecting a circulating tumor cell (CTC) in a biological sample, the kit comprising an antibody to at least one EMT biomarker and instructions for use, wherein the antibody is linked to a fluorescent reporter molecule,
radionuclide, enzyme, or magnetic bead; see entire document, e.g. abstract, [0009], claims 7-9.
Garcia-blanco et al. teach the EMT biomarker includes vimentin, N-cadherin, O-cadherin (also known as OB-cadherin), E-cadherin, FGFR2 splice variant isoforms, or CD133 (instant claim 8); see [0041], page 52, claims 3 and 9.
Garcia-blanco et al. teach detectable molecules are used for the detection of one or more EMT biomarker, wherein the detectable molecules include fluorophores, enzyme, radionuclides, nuclear stains (e.g., DAPI) (instant claim 9); see [0045], claim 8.
Garcia-blanco et al. teach the antibody is associated a magnetic bead (instant claims 10-11); see [0046], claim 8.
Garcia-blanco et al. do not teach β-catenin as a biomarker for CTCs.
However, this deficiency is remedied by Scatena et al.
Scatena et al. teach β-catenin as a valuable biomarker for CTCs; see entire document, e.g. first paragraph of right col. on page 133, pages 138-139.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of the references so as to have a kit for detecting a circulating tumor cell (CTC) in a biological sample, the kit comprising an antibody to at least one EMT biomarker and confirming the circulating tumor cell using β-catenin detection. One would have been motivated to do so because Garcia-blanco et al. teach a kit for detecting a circulating tumor cell (CTC) in a biological sample, the kit comprising an antibody to at least one EMT biomarker and instructions for use; Scatena et al. teach β-catenin as a valuable biomarker for CTCs. Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to have a kit for detecting a circulating tumor cell (CTC) in a biological sample, the kit comprising an antibody to at least one EMT biomarker and confirming the circulating tumor cell using β-catenin detection by a detectably labeled anti-β-catenin antibody, because β-catenin as a valuable biomarker for CTCs as taught by Scatena et al.
Conclusion
11. No claim is allowed.
12. Applicant's amendment necessitated the new ground(s) of objection/rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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