DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed May 15, 2026. Currently, claims 1-17 are pending. Claims 16-17 have been withdrawn as drawn to non-elected subject matter.
Election/Restrictions
Applicant's election of Group I, Claims 1-15 in the paper filed May 15, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
It is noted that a translation of the foreign document has not been received.
Drawings
The drawings are acceptable.
Claim Rejections - 35 USC § 112- Second Paragraph
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.
Claims 7-13 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 pre-AIA the applicant regards as the invention.
A) Claims 7-13 are indefinite because it claims both product and methods steps for using the products. Claim 7 is directed to “the oligonucleotide probe is cleaved by a nucleotlytic reaction”. Claim 11 is also directed to the biotin binds the at least one biotin-affinity protein which is a method step/limitation. As the limitations of the claim are drawn to a method step, and not to a further product limitation of the kit, there is confusion as to when direct infringement occurs. See MPEP 2173.05(p).
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.
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 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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR2011-0102842 (September 19, 2011)(Translation attached).
KR2011-0102842 teaches real-time detection of Salmonella using cleavable chimeric probes. KR2011-0102842 teaches the Salmonella probe may be attached to a solid support.
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With respect to Claims 2-3, Salmonella is a gram negative bacteria.
With respect to Claim 4, KR2011-0102842 teaches probes can be attached to the solid support by attaching a 3’ or 5’ terminal nucleotide of the probe to the solid support.
With respect to Claim 5, the solid surface may be polystyrene, avidin coated polystyrene bead cellulose, nylon, acrylamide gel and activated dextran, controlled pore glass (CPG), glass plates and Highly cross-linked polystyrene.
With respect to Claim 6, the probe comprises a donor and quencher label.
With respect to Claim 7, RNase H is present to cleave probes.
With respect to Claims 8, 10-13, the label may be a fluorescent label such as a FRET pair. Detectable label may also, any useful linker molecule (e.g., biotin, avidin, strap bit avidin, HRP, protein A, protein G, an antibody or a fragment thereof, Grb2, polyhistidine, Ni 2 +, FLAG tag, myc Tags), heavy metals, enzymes (e.g. alkaline phosphatase, peroxidase and luciferase), electron donors / acceptors, acridinium esters, dyes and calorimetric substrates It includes.
With respect to Claim 9, the claim includes a method step that does not appear to materially limit the product claims.
With respect to Claim 14, the probe is a single strand.
With respect to Claim 15, the solid support may be in a kit comprising a packaging unit having one or more reaction reagents for real-time detection of Salmonella target nucleic acid in the sample.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US 8,278,048, October 2, 2012).
Smith teaches a solid support with an oligonucleotide probe immobilized thereto. Smith teaches the probe may be for bacteria, fungi, protozoa (column 2, lines 1-5).
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With respect to Claim 2-3, Smith teaches analysis of microorganisms including E. coli, which is a gram-negative bacteria (para 2, lines 12-15).
With respect to Claim 4, the probe (101) is attached thru the 5’ or 3’ end to the solid surface.
With respect to Claim 5, Examples of solid supports include, without limitation, a well of a microtiter plate (e.g., a 96-well microtiter plate or ELISA plate), beads (e.g., magnetic, glass, plastic, or gold-coated beads), slides (e.g., glass or gold-coated slides), micro- or nano-particles (e.g., carbon nanotubes), platinum solid supports, palladium solid supports, and a surface of a chamber or channel within a microfluidic device (col, 24, lines 48-60).
With respect to Claim 6, the oligonucleotide probe may have a restriction endonuclease (Ra) attached.
With respect to Claim 7, Smith teaches the probe may be contacted with a sample to form a double-stranded section that may be cut with a recognition restriction endonuclease to clear the endonuclease.
With respect to Claim 8, Smith teaches the label can be a fluorescent label, a radioactive label, an enzyme label, or a redox label (col. 3, lines 20-30).
With respect to Claim 10-11, Smith teaches biotin can be a component of signal expansion nucleic acid or reporter nucleic acid. The biotin can be indirectly attached to a solid support that is coated with streptavidin via a biotin-streptavidin interaction.
With respect to Claim 12-14, Smith teaches an oligonucleotide probe may be biotinylated at the 3’end was conjugated to horseradish peroxidase (HRP). The HRP conjugate was incubated with a streptavidin coated ELISA plate to immobilize the HRP oligonucleotide probe to the surface via a biotin-streptavidin interaction (Example 1, col 34). The plate was incubated with a restriction endonuclease BfaI and cleaved a double stranded target-probe hybrid to release the HRP-oligonucleotide into the solution and further detected.
With respect to Claim 15, Smith teaches a kit comprising the solid support.
Conclusion
No claims allowable over the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
July 10, 2026
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