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 .
Election/Restrictions
Applicant’s election of claims 1-3 in the reply filed on 12/1/2025 is acknowledged. 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)).
However, in view of the prior art search, the restriction requirement is withdrawn. Claims 1-4 are under examination herein.
Priority
This application is a CON of PCT/JP2021/030430 (8/19/2021) which claims priority to JP2020-202843 (12/7/2020) as reflected in the filing receipt issued on 5/8/2024.
The certified copy of the foreign priority document is not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 1/24/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leiderman et al., Arteriosclerosis, thrombosis, and vascular biology; 36(12):2334-45.
Regarding claim 1, Leiderman teaches activated blood coagulation factor XI (FXIa) and tissue factor (TF) added to plasma (Leiderman p. 2337 para. 2 and Fig. 2). This is considered to be a blood coagulation test reagent, as the FXIa and TF are added together to react with a plasma sample.
Regarding claim 2, Leiderman teaches that the reagent comprises 5.4 pM FXIa and 0.02 pM (or 20 fM) of TF (Leiderman Fig. 2C). This is a FXIa/TF ratio of 270.
Regarding claim 3, the “wherein” clause is directed to an intended use of the claimed reagent, for testing an indicator related to hemorrhagic diseases caused by a decrease in blood coagulant activity. It is considered that any composition according to claim 1, which comprises FXIa and TF, is capable of performing this intended use. Leiderman teaches such a composition. Further, Leiderman teaches that the reagent is used to measure thrombin generation, which is an indicator related to hemorrhagic diseases (Leiderman Fig. 2).
Regarding claim 4, Leiderman teaches a method comprising measuring thrombin generated by reacting a biological sample, plasma, with a reagent comprising 5.4 pM FXIa and 0.02 pM (20 fM) TF (Leiderman Fig. 2C).
Conclusion
Claims 1-4 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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, Sharmila Landau can be reached at (571)272-0614. 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.
/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653