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 .
Applicant's preliminary amendment, dated October 4, 2023, has been received. By way of this submission, Applicant has amended claim 8 and introduced new claims 11-16.
Claims 1-16 are pending in the application and under examination before the Office.
Priority
The certified copy of the foreign priority document submitted in the application on November 2, 2023 is in Chinese. As such, Applicant cannot rely upon the certified copy of the foreign priority application to overcome rejections because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP 215 and 216.
Therefore, for the purposes of the prior art, the effective filing date is October 4, 2023, the filing date of the United States application.
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 1-16 are 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 1 recites nine different systems each with its own components. However, the claims as written appear to reuse the same component multiple times. For example, the blank system comprises self-cells and phosphate-buffered saline (PBS), and the negative control system comprises RhD negative cells, IgG anti-D serum, and the PBS. As written, the same PBS is used in both the blank and the negative control system. Similar conflicts appear for the IgG anti-D serum of the positive control, the drug liquid, and the self-plasma for the enzyme-reaction drug detection system, and so forth. It is not readily apparent as to how these systems are meant to be used in such an interchangeable manner, if the same reagent can be shared or re-used from one system to another. Clarification is requested.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Brockhaus (US20200309786A1) teaches a method of detecting anti-drug antibodies in a sample (see, e.g., para. 0005). However, Brockhaus does not teach the claimed systems.
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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