Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 12 May 2026 has been entered.
Status of the Claims
Claims 5, 9, 20, and 21 are cancelled.
Claims 1-4, 6-8, 10-19, and 22-34 examined on the merits.
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 1-4, 6-8, 10-19, and 22-34 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.
Independent claims 1, 24, and 33 all recite in the preamble that they are “a method of testing a human subject for presence of a colorectal malignancy and/or pre-malignancy” and recite steps for collecting the sample, receiving the sample, testing the sample for blood and detecting human nucleic acid in the sample, but there is nothing in the claims to test for a colorectal (pre)malignancy. The claims do not recite a step that indicates the presence or absence of a colorectal (pre)malignancy, only a detection of blood or nucleic acids. None of the steps indicate what determines if there is a colorectal (pre)malignancy.
Claims 31 and 32 recite testing the subject for adenoma or advanced adenoma but the claims do not recite how that is achieved. There is no active method step that achieves this step nor is there a result from any of the steps in the claims that states what the testing is based on.
Claims 2-4, 6-8, 10-19, 22, 23, 25-30, and 34 do not recite any additional steps that overcome the rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MINDY G BROWN whose telephone number is (571)270-5605. The examiner can normally be reached Monday -Friday, 9:00 am - 5:00 pm EST.
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/MINDY G BROWN/Patent Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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