DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 amendment filed on 10/20/2025has been received and entered into record and considered.
The following information provided in the amendment affects the instant application:
Claims 1-88 have been cancelled.
Claims 89-101 are pending and under examination.
The rejection on claims 71-90 under 35 USC, 112(a), new matter is moot because of the cancelation of claims.
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 89-101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 10401368. Although the claims at issue are not identical, they are not patentably distinct from each other because the 368’ patent uses the same antibody having both SEQ ID No. 5 and SEQ ID No. 7 on both heavy and light chain to bind to SEQ ID No. 2 epitope. Also 368’ patent recites using the same two antibodies having same SEQ ID Nos and not overlapping epitopes (i.e. sandwich assay) for detecting cytokeratin 18 (CK18). Moreover, 368’ patent also recites kits having the same antibodies for detection CK18. Note, the SEQ ID No. 1 Ala-Ser-Ser-Gly-Leu-Thr-Val-Glu-Val-Asp) in the kit claim of 368’ encompasses current SEQ ID No. 2 (Val-Glu-Val-Asp) since both SEQ ID No.1 and SEQ ID No. 2 are all part of C-terminal fragments of CK18 protein.
Claims 89-101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11175295 in view of Miller (US10401368). Although the claims at issue are not identical, they are not patentably distinct from each other because 295’ patent recites an isolated antibody comprises a heavy chain of SEQ ID No. 5 and a light chain of SEQ ID No. 7 and the antibody is capable of recognizing SEQ ID No. 1 epitope of CK18. It is noted that 295’ patent does not explicitly teach using a secondary antibody for detection of CK18. Nevertheless using a secondary antibody, e.g. sandwich assay, is well-known and commonly practiced in the field. For instance, Miller teaches using immunoassay for detecting CK18 protein. Miller teaches using sandwich assaying employing two antibodies, i.e. one for epitope SEQ ID No. 1, the other for recognizing CK18 but not overlapping with the epitope SEQ ID No. 1 (claims 15-34). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method taught by Cho using a secondary antibody specific for CK18 as a sandwich assay with reasonable expectation of success.
Under KSR case law, it is now apparent "obvious to try" may be an appropriate test in more situations. “When there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense”. In that instance the fact that a combination was obvious to try might show that it was obvious under 35 USC 103. See KSR Int'l Co v. Teleflex Inc., 127 S. Ct. 1727; 82 USPQ 1385, 1397 (2007). The problem facing those in the art was to measure CK18, and there were a number of methodologies available to do so. The skilled artisan would have reason to try these methodologies with reasonable expectation that at least one would be successful. Thus, using a secondary antibody targeting CK18 while not overlapping epitope with the first antibody in a sandwich assay was “the product not of innovation but of ordinary skill and common sense.”
Claim Objections
Claim 90 is objected to because of the following informalities: it is noted a redundance of “wherein the” at the first line of claim 90. Appropriate correction is required.
A telephonic call was made to Dr. Bouchez with regarding the aforementioned issues. Dr. Bouchez indicated that applicants would consider the issues and file appropriate response in due time.
Conclusion
No claim is allowed.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678