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 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, 16 and 17 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 3-5, 16 and 17 contain the trademark/trade name “Illumina” (e.g., “Illumina P5”, “Illumina P7”, “Illumina Read 1”, “Illumina Read 2”, “Illumina sequencing primer site”, “Illumina paired-end sequencing site”, etc.). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe particular nucleotide sequences and, accordingly, the identification/description is indefinite.
Claims 14-19 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 14 recites “wherein the second primer has a second annealing temperature” (emphasis provided). However, the claim never recites any first annealing temperature, which raises an uncertainty as to where the claim requires some “first” annealing temperature. As claims 15-19 depend from claim 14, they are rejected for the same reason.
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.
Claim(s) 14, 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber (WO 2009/153327 A1) in view of Park (US 6,153,412) and Ong (WO 2021/201782 A1).
Weber disclosed drying components of a PCR reaction, including a biotinylated forward primer and reverse primer, in a PCR reaction vessel (page 15, lines 9-16). Here, the reverse primer would correspond to the claimed “second primer”. Because there is no sequence specified for the recited “third primer”, any sequence could be a “third primer”, including those with an annealing temperature lower than the Weber’s reverse primer (note that the recited “third primer” is not indicated by the claim as being present in the plate, it is only referenced).
Weber did not disclose sucrose, or a “substantially planar member comprising a plurality of wells”.
Park disclosed that sucrose could be used as an alternative to trehalose as a stabilizer in drying PCR components (column 6, lines 49-60).
Ong disclosed drying PCR components in the wells of a 96-well plate (paragraph [0026]).
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 modify the dried PCR reagents of Weber by substituting (or combining) trehalose with sucrose since both were taught in the art as stabilizers for making dried PCR reagent compositions. It would also have been obvious to substitute the single PCR reaction vessel of Weber for a 96-well plate as both were taught in the art as containers for making dried PCR reagent compositions. See MPEP 2144.06.
Conclusion
Claims 1, 2 and 6-13 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Makarov (WO 2018/048957 A2) disclosed methods for normalizing sequencing library concentrations. The process involved amplification of library members with a pair of primers, one of which was labeled with biotin, followed by capture of the amplicons on streptavidin beads. A limiting concentration of “normalization probe” was annealed to the captured strands which allowed for a specific amount of the captured strands to be released from the beads (Figure 4, paragraph [0013]). Betts (US 2017/0073730) disclosed methods for normalizing libraries comprising amplification using a pair of primers, one of which was biotin-labeled. The amplicons are denatured, followed by capture of the biotin-labeled strands. Abundant amplicons renature quickly and are removed, whereas rare amplicons denature slowly, leaving the non-biotinylated strand free in solution (paragraph [0018]). The prior art does not teach or suggest normalizing by the method of instant claim 1.
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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681