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 .
Status of the Claims
Claims 1-15 are pending and have been examined herein.
Priority
This application, filed 01/22/2024, is a 371 or PCT/JP2022/0286898, filed 07/26/2022, which claims priority to JAPAN 2021/121812, filed 07/26/2021. This priority is acknowledged and the claims examined herein are treated as having an effective filing date of 07/26/2021.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 01/22/2024, 04/18/2025, and 06/06/2025 are acknowledged and have been considered.
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.
Claims 5-6 and 12-15 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 5 recites “The reagent…which is used for diagnosis” and claim 6 recites “The reagent…which is used for research”; however, because the reagent of claim 1 lacks any functional description beyond that it binds a target, it is unclear what diagnosing or research could be accomplished using the claimed antibody.
Regarding claims 12-15, the claims are directed to “A method for inhibiting a non-specific reaction”; however, the claims fail to distinctly claim any active steps as part of the method. In claim 12, the recitation of “method involving the use of a humanized antibody against a target substance” is not considered to limit the claimed method with any particular and distinctly claimed steps.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuroki et al., “Reducing interference from heterophilic antibodies in a two-site immunoassay for carcinoembryonic antigen (CEA) by using a human/mouse chimeric antibody to CEA as the tracer” Journal of Immunological Methods (published 03/13/1995, referred to herein as Kuroki).
Regarding claims 1, 2, 5 and 6, If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In order words, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 II. In this case, the claimed reagent recited as “An immunoassay reagent” in claim 1 is not limited by the recitation of “immunoassay” which is considered directed towards an intended use of the reagent that does not limit the structure of the reagent itself. Further, claim 2 recites “inhibits a non-specific reaction” which is directed toward the immunoassay of claim 1. Further, claim 5 recites “which is used for diagnosis” and claim 6 recites “which is used for research” which are also directed toward intended uses of the claimed reagent which do not limit the structure of the reagent.
Regarding claim 1, 5, and 6, Kuroki teaches a reagent, Chimeric antibody “Ch F11-39”, that targets CEA (p. 84, col. 2, para. 2, lines 1-10). Kuorki teaches that this antibody is a chimeric antibody with mouse and human regions (p. 82, col. 2, para. 3, lines 1-8), which is considered to be humanized as supported by the instant specification (para. 0017, lines 1-7).
Regarding claim 2, Kuroki teaches that this antibody inhibits HAMA interference, which is a non-specific reaction (p. 83, col. 1, para. 1, lines 1-6).
Regarding claims 3, 10, and 14, Kuroki teaches that the antibody is IgG (p. 83, col. 2, para. 1, line 3).
Claims 4, 11, and 15 are considered a “Product-by-Process” claim (see MPEP 2113). Regarding product-by-process claims, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
(emphasis added). In this case, the claimed antibody would have the claimed structure, i.e. humanized, regardless of the method by which it was made.
Regarding claims 8-9 and 12-13, Kuroki teaches an immunoassay comprising bringing a humanized antibody against a target into contact with the target, which inhibits interference by HAMAs (p. 84, col. 2, para. 3, lines 7-13).
Claims 1 and 7 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20110165621 A1 “HUMANIZED ANTIBODIES” (published 07/07/2011, referred to herein as Dreier).
Regarding claims 1 and 7, Dreier teaches a humanized antibody for an immunoassay in a kit (para. 00354, lines 1-5).
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 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 24 of copending Application No. 17/914,282 (reference application, referred to herein as ‘282). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 8-15 of the instant application, ‘828 discloses an immunoassay method for suppressing non-specific reactions comprising bringing a humanized (‘828 claim 24) IgG antibody in contact with the target (‘828 claim 20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20030119078 A1, “Method Of Reducing Immunogenicity Of Toxicity Of An Antibody Of IgG Class” teaches methods of making humanized antibodies, which includes using plant based expression systems (for example, paras. 0139-0141).
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER EVANS whose telephone number is (571)272-4897. The examiner can normally be reached Mon - Fri 8:30am to 4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at (517) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 June 3, 2026
Prosecution Insights