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 .
Claim Objections
Claim 15 is objected to because of the following informalities: “at least one labelled or more labelled analyte specific oligonucleotide probe” should be corrected to “one or more labelled analyte specific oligonucleotide probes”. 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 3, 5 and 15 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 3 recites the limitation "the non-backbone-modification". Claim 5 recites “the plurality of Tx probes”. There is insufficient antecedent basis for these limitations in these claims.
Claim 15 recites the limitation “the hybridizing sequence” and “the cleavable hydrolysis product”. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Den Boom (WO 2009/073251 A1, IDS ref) in view of Polansky (US 2004/0023207).
Van Den Boom disclosed an assay in which multiple probes were used to detect multiple target sequences on the Y chromosome; see Example 4, beginning on page 50. These probes comprised a 3’ target-complementary portion and a 5’ target-non-complementary portion. The probes comprised LNA nucleotides between the two portions (LNA being nuclease-resistant) and 3’ phosphates or inverted deoxythymidine (which would prevent polymerase extension). The probes also comprised biotin (a label) at the 5’ end.
Van Den Boom did not disclose putting these probes in a “kit”.
Polansky taught (paragraph [0919]): “Well known advantages of commercial kits include convenience and reproducibility due to manufacturing standardization, quality control and validation procedures.”
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application to put the probes and other reagents for performing Van Den Boom’s method into a kit to obtain the advantages of kits disclosed by Polansky.
Conclusion
Claims 3, 5 and 15 are rejected.
Claims 1, 2, 4 and 6-14 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is Lao (US 2006/0024714). Lao disclosed the use of multiple flap probes in multiplex format to analyze a plurality of targets (paragraph [0008]). Lao disclosed: “In some embodiments, the flap sequences of two or more probes can be substantially unique. Therefore, in some embodiments a flap sequence can be a code sequence.” Lao disclosed (paragraph [0029]): “In one non-limiting example, a flap sequence may be a code sequence by being one nucleotide longer or shorter than another flap sequence. In some embodiments, such flap sequences may be differentiated by electrophoretic techniques, including but not limited to, capillary electrophoresis.” Lao disclosed (paragraph [0058]): “…in some embodiments, each flap sequence may comprise the identical detectable moiety. In these embodiments, each released flap sequence may be individually discriminated if, for example, each flap sequence is substantially unique. For example, in embodiments in which each flap sequence differs in length by at least one nucleobase, the individual flap sequence may be conveniently discriminated by capillary electrophoresis.” However, Lao did not disclose or suggest flap probes having “at least one internal nuclease blocker at the 5’-region of the hybridizing sequence of the TX probe conferring resistance to a nuclease activity and structurally dividing a cleavable hydrolysis product from the 3’-downstream TX probe”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681