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 .
Claims Status and Formal Matters
Claims 1-2, 5, 8, 8, 13, 18, 23, 26, 32, 42, 45, 47, 49, 56-57, 68, 85-86 are pending and being examined.
Priority
The instant application was filed 03/10/2023 and claims priority from provisional application 63319168 , filed 03/11/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/13/2023 and 2/8/2024 are being considered by the examiner.
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 1-2, 5, 8, 8, 13, 18, 23, 26, 32, 42, 45, 47, 49, 56-57, 68, 85-86 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 1 recites, “pre-formed detectable probe.” The recitation of “pre-formed” suggests there are probes that are no pre-formed. The specification and claims provide no specific standard to determine what pre-formed is relative to. Thus the metes and bounds are unclear.
Claim 8 recites, “the unit sequence.” Niether claim 8 nor claim 1 from which it depends recites “unit sequence.” Thus the limitation lack antecedent basis. Further, the specification does not provide a definition of “unit sequence.” “Unit sequence” is not an art accepted term. Thus the metes and bounds are unclear.
Claim 85 recites, “unit sequence.” The specification does not provide a definition of “unit sequence.” “Unit sequence” is not an art accepted term. Thus the metes and bounds are unclear.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-2, 5, 8, 8, 13, 18, 23, 26, 32, 45, 47, 49, 56-57, 68, 85-86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dahl (WO2004058989) and Mohsen (Acc. Chem. Res. 2016, 49, 2540−2550)
The specification does not limit target sequence or biological sample. Thus the broadest reasonable interpretation is any target sequence in any sample.
With regards to claim 1-3, 85Dahl teaches
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Dahl does not specifically teach the length of the concatamers.
However Mohsen teaches RCA can produce yield 100 concatenated copies of a cirlcle.
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims the RCA product of figure 21 of Dahl could comprise 20 or more concatenated copies of the initial RCA product prior to addition of the additional bipartite probes. The artisan would be motivated to initially provide 20 or more copies of the sequence for amplification and thus easier detection in later steps. The artisan would have a reasonable expectation of success as the artisan is merely using known methods.
With regards to claim 5, Dahl teaches fluorescently labeled nucleotides (0091).
With regards to claim 8, 13, 86 Dah teaches the use of a tag comprising a target sequence that can be detected by target probes, which can be labeled (00431)/
With regards to claim 18, Dahl teaches in situ detection (0209)
With regards to claim 23, Dahl in figure 21 teaches the target binding region is within the concatemer region.
With regards to claim 26, Dahl teaches the use of UMP in RCA which provide a cleavable site in the probe (0176)
With regards to claim 32, Dahl teaches
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With regards 45,47 Dahl teaches, “With respect to the present invention, an analyte is often associated with a biological entity that is present in a sample if and only if the analyte is present. Such biological entities include viroids ( analyte is, e.g., a segment of a viroid nucleic acid sequence); viruses (analyte is, e.g., a sequence in the viral genome); other microorganisms (analyte is, e.g., a sequence in the genome or the RNA of the microorganism); abnormal cells, such as cancer cells (analyte is, e.g., a sequence in an oncogene); or an abnormal gene (analyte is, e.g., a sequence in a gene segment that includes the altered bases which render the gene abnormal or in a messenger RNA segment that includes altered bases as a result of having been transcribed from the abnormal gene).” (0105),
The specification provides no limiting definition of barcode. Thus the broadest reasonable interpretation is any nucleic acid sequence.
With regards to claim 49, 56 Dahl teaches the use of a tag comprising a target sequence that can be detected by target probes, which can be labeled (00431)
With regards to claim 57, Dahl in figure 21 teaches synthesizing the target sequence. Dahl teaches the method can be in situ
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to synthesize the target nucleic acid in situ. The artisan would be motivated to perform the method in situ as Dahl teaches the method can be performed in situ. The artisan would have a reasonable expectation of success as the artisan is merely using known methods.
With regards to claim 68, Dahl teaches confocal imaging (217).
With regards to claim 736, Dahl teaches Tissue samples (0100).
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dahl (WO2004058989) and Mohsen (Acc. Chem. Res. 2016, 49, 2540−2550) as applied to claims 1-2, 5, 8, 8, 13, 18, 23, 26, 32, 45, 47, 49, 56-57, 68, 85-86 above, and further in view of Chen (Nucleic Acids Research, 2018, Vol. 46, No. 4 e22)
While Dahl and Mohsen teach method of using RCA and RCA products for detection of nucleic acids.
Dahl and Mohsen do not specifically teach nanoballs of about 0.1 micrometers to 1.5 micrometers.
However, Chen teaches, “The circularized padlock probe is then used as a template for rolling circle amplification (RCA), producing a rolling circle colony, or ‘rolony’––a <1µm nanoball of DNA that consists of thousands of copies of original sequence.” ((page 1, 2nd column, 1st paragraph).
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims the RCA methods of Dahl and Mohsen would produce nanoballs of <1µm nanoball of DNA that consists of thousands of copies of original sequence. The artisan would be motivated as Chen teaches nanoballs of <1µm nanoball of DNA that consists of thousands of copies of original sequence. The artisan would have a reasonable expectation of success as the artisan would have a reasonable expectation of success as the artisan is merely following teachings of art.
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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/Steven Pohnert/ Primary Examiner, Art Unit 1683