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 without traverse of group I in the reply filed on 5/19/2026 is acknowledged.
Claims 1,3-5,7-8,11,13-14,16,18-19,22,25,31,43,54,55,59-60,62-63,79,86 are pending. CLiams 2,6,9-10,12,15,17,20-21,23-24,26-60,634-42,44-53,56-58,61,64-78,80-85,87-96 are cancelled.
Claims 31,43,79,86 are withdrawn as being drawn to a nonelected invention.
An action on the merits for claims 1,3-5,7-8,11,13-14,16,18-19,22,25 ,54,55,59-60,62-63 are set forth below.
Claim Objections
Claim 1 is objected to because of the following informalities: Steps a and b of claim 1 have different formatting, it is suggested that “a.” is changed to “(a)”. 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 1,3-5,7-8,11,13-14,16,18-19,22,25 ,54,55,59-60,62-63 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.
Claims 1,3-5,7-8,11,13-14,16,18-19,22,25 are indefinite. The wherein clause request “the hydrolase cleaves” however there is no hydrolase required by the positive active step. As such the claims appear non-functional; as step b cannot be performed without the hydrolase.
Claims 54,55,59-60,62-63 are indefinite. The wherein clause request “the hydrolase enzyme cleaves” however there is no hydrolase enzyme required by the positive active step. As such the claims appear non-functional; as step b cannot be performed without the hydrolase enzyme.
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.
Claim(s) 1,3-5,7-8,11,13-14,16,18-19,22,25 ,54,55,59-60,62-63 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Keener et al. (WO 2007/120298 October 25, 2007, cited on IDS).
With regard to claim 1, Keener et al. teaches a method comprise contacting a sample with an “oligonucleotide detection reagent” as Keener et al. teaches an oligonucleotide that comprises a complement, a blocker that is complementary to a portion, a hydrolase cleavage side (p. 4 and 19). Keener et al. teaches a hydrolase cleaves the reagent and detecting the unblocked oligonucleotide (p. 19 and 20).
With regard to claim 3, Keener et al. teaches further a label is placed on the oligonucleotides (para 64).
Wit regard to claim 4, Keener et al. teaches a blocker on the 5’ halves, a hydrolase cleavage site, complement and labels (p. 26-27).
With regard to claim 5, Keener et al. teaches the complement is on the first strand, and the cleavage and blocker are on the second (figure 1a and para 38, p. 26-27).
With regard to claim 7, Keener et al. teaches that the oligonucleotides can be a hairpin loop structure (para 11).
With regard to claim 8, Keener et al. teaches that the hydrolase enzyme is a nuclease of glycoside hydrolase and the cleavage site within the nucleic acid (p. 2-3).
With regard to claim 11, Keener et al. teaches a method wherein an immobilizing the unblocked oligonucleotide to a substrate and the uncleaved oligonucleotide does not bind (para 10 and 53).
With regard to claim 13, Keener et al. teaches performing a primer extension and detection using PCR (p. 22).
With regard to claim 14, Keener et al. teaches using the extension produce and detection on an array (p. 23).
With regard to claim 16, Keener et al. teaches that the complement to the blocker prevents binding (para 81-82).
With regard to claims 18-19, Keener et al. teaches a method wherein the label is detected by ECL (para 83).
With regard to claims 22,25, Keener et all teaches using a multiple well plate and using a multiplexed method (para 71 and p. 26).
With regard to claim 54, Keener et al. teaches a method comprise contacting a sample with an “oligonucleotide detection reagent” as Keener et al. teaches an oligonucleotide that comprises a complement, a blocker that is complementary to a portion, a hydrolase cleavage side (p. 4 and 19). Keener et al. teaches a hydrolase cleaves the reagent and detecting the unblocked oligonucleotide (p. 19 and 20).Keener et al teaches detecting the first cleaved oligonucleotide detection reagent immobilized on
the detection surface, wherein the cleaved secondary targeting agent complement and the uncleaved oligonucleotide detection reagent on the binding surface are substantially undetected (para 81-83, p. 23-25).
With regard to claim 55, Keener et al. teaches that a secondary targeting agent complement (Ru ODN anneals to unblock product) is attached to a first terminus of the hydrolase cleavage site, a first terminus of the primary targeting agent complement is attached to a second terminus of the hydrolase cleavage site, and the detectable label is attached to a second terminus of the primary targeting
agent complement (figure 1a).
With regard to claim 59, Keener et al. teaches that the agent complement comprises a nuclease resistant nucleotide (para 83).
With regard to claim 60, Keener et al. teaches 2’O-methyl nucleotide (para 84).
With regard to claim 62, Keener et al. teaches that the method comprises biotin and streptavidin (para 87).
With regard to claim 63, Keener et al. teaches that the agent is unreactive with the agent and complement (para 60, 87).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682
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