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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. In particular, paragraph [0037] lists references which are not included on an information disclosure statement.
Claim Interpretation
Claims 5-7 and 16 use the language “…or in a base sequence provided by the deletion, substitution, insertion, or addition of one or a plurality of bases…”. This can be broadly interpreted to encompasses any sequence of any size as there is no limit to the “plurality of bases” that can be used to modify the claimed sequences. Therefore, any target gene with a GC content of at least 60% which is asymmetrically amplified by any primer set, in which the primers are present at different concentrations, and further detected by any probe, will be interpreted as reading on the claims of the instant application.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102a(1)/a(2) as being anticipated by Chen (CN 107338315 B).
Chen discloses a kit for rapidly detecting 15 pneumonia pathogenic bacteria including Pseudomonas aeruginosa (abstract), a bacterium characterized by a high GC content. Primer pairs specific for each bacterium were labeled with biotin on the downstream 5` end, and divided into three multiplexed reactions in which 4-6 targets were amplified simultaneously (p6, L20-29). By using a ratio of upstream and downstream primers of 1:5, asymmetric PCR amplification of the targets was achieved (p15, L6-8).
Chen further discloses a method of detecting the amplification product of the above reaction through the use of a gene chip in which target specific probes are present. Chen teaches that gene chips function by detectably labeling primers/probes, immobilizing probes onto a support, hybridizing the probes with single stranded analytes, and interpreting the results of the hybridization signal (p2, L33-36; p29, L38-39). Each probe includes a target specific sequence, a 3` poly-T tail, and is labeled on the 3` end with an amino group (p12, L3-5).
For P. aeruginosa, Chen targeted the toxA gene (p29, L18-21) and used a probe complementary to the amplification product of the reverse primer, which was present in the reaction at a higher concentration than the forward primer (Table 1-10). The sequences of the primers, amplification product, and probe target are depicted below:
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349
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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.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Tsao (US 10302640 B2).
Claims 17 and 18 both depend from claims 10 and 14 which describe a method of detecting a target gene with a high GC content in which an amplification product is detected through the use of an immobilized probe on a detection substrate material which is complementary to said product. This is taught by Chen, as discussed in the 35 USC 102 rejection.
Chen does not teach that the detection substrate is a coded microcarrier.
However, Tsao teaches an encoded microcarrier (Tsao, abstract). A comparison of the characteristics of the microcarriers from the instant application and from Tsao is below:
Encoded Microcarrier Characteristics
Claim 18
(Instant Application)
Tsao
(C2, L53-67)
A substantially transparent polymer layer having:
A substantially transparent polymer layer having:
•
First and second surface which are parallel to each other
•
First and second surface which are parallel to each other
A substantially opaque polymer layer
A substantially opaque polymer layer
•
Affixed to the first surface of the substantially transparent polymer layer
•
Affixed to the first surface of the substantially transparent polymer layer
•
Encompassing a central region of the substantially transparent polymer layer
•
Enclosing a center portion of the substantially transparent polymer layer
•
Containing a 2D shape that represents an analog code
•
Comprising a 2D shape representing an analog code
A capture agent for capturing an analyte
A capture agent for capturing an analyte
•
Attached to at least one of the first and second surface of the substantially transparent polymer layer
•
Coupled to at least one of the first and the second surface of the substantially transparent polymer layer
•
In at least the central region of the substantially transparent polymer layer
•
In at least the center portion of the substantially transparent polymer layer
Tsao states that these microcarriers represent an improvement in multiplex assay detection due to their ability to simultaneously detect a larger number of analytes (due to the large number of unique microcarriers) with reduced recognition error (Tsao, C29, L38-42). Chen teaches that the ability to rapidly, accurately, and sensitively detect pneumonia-causing bacteria is important for early diagnosis and treatment (Chen, p1, L37-39), and Chen’s use of the gene chip was in pursuit of this goal (Chen, p30, L11-14). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the amplification method of Chen with the detection method of Tsao in order to further improve the identification of bacterial strains with clinical significance.
A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Conclusion
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/K.N.K./Examiner, Art Unit 1681
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681