DETAILED ACTION
Response to Amendment
Applicant’s responses to the office action filed on June 22, 2026 and August 21, 2026 have been entered. The claims pending in this application are claims 16, 21, 23, 28, 30, 31, 33, 34, 37, 41, 42, 45, and 46. The objections and rejections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendments filed on June 22, 2026 and August 21, 2026. Claims 16, 21, 23, 28, 30, 31, 33, 34, 37, 41, 42, 45, and 46 will be examined.
Claim Objections
Claim 16 is objected to because of the following informality: “is specific for” in (B) (i) should be “specifically binds to”.
Claim 16 or 23 or 45 is objected to because of the following informality: “primers and/or probes” in the end of the claim should be “primers and probes”.
Claim 34 is objected to because of the following informality: “is adapted for use in” should be “is used for”.
Appropriate correction is required.
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 16, 21, 23, 28, 30, 31, 33, 34, 37, 41, 42, 45, and 46 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 16 or 23 or 45 is rejected as vague and indefinite. Although the first part of the claim requires that each of said detecting molecules specifically binds to one of said biomarker proteins wherein said at least six detecting molecules are selected from amino acid detecting molecules, nucleic acid detecting molecules, and any a combination combinations thereof, since the second part of the claim only requires that said nucleic acid detecting molecules are oligonucleotides wherein each oligonucleotide specifically hybridizes to a nucleic acid sequence encoding said one of said biomarker proteins and said oligonucleotides are selected from primers and probes and does not require that each of oligonucleotides specifically binds one of said biomarker proteins, it is unclear why each of oligonucleotides can serve as a detecting molecule which specifically binds to one of said biomarker proteins such that the first part and the second part do not correspond from each other. Please clarify.
Conclusion
Applicant's amendment necessitated the new ground(s) of 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph. D., whose telephone number is (571)272-0746. The examiner can normally be reached Monday to Friday, 9 AM to 5 PM.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
October 9, 2026
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