Detailed Action
► The applicant's Preliminary Amendment filed 06 DEC 2023 has been entered. Following the entry of the Preliminary Amendment, Claim(s) 25-38 is/are pending.
► The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
► This application is a CON of USSN 16/898338 filed 10 JUN 2020, now US PAT 11,493,505 which is a CON of PCT/CA2019/050404 filed 03 APR 2019
Which Claims priority to US PRO 62651943 filed 03 APR 2018
The Claims of the instant application have basis in US PRO 62651943 filed 03 APR 2018. See at least Fig, 2..Accordingly, the priority date afforded the instant invention is 03 APR 2018.
Sequence Rules
► This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). See Fig. 18 (Drawing Sheet 10 of 13) However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures.
Drawings
► New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
In Fig. 18 (sheet g 10 of 13) the lines, numbers and lettering are not clean, well-defined, sufficiently dense and dark, and uniformly thick and well defined See 37 CFR 1.84(l) and (q).
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
INFORMATION ON HOW TO EFFECT DRAWING CHANGES
Replacement Drawing Sheets
Drawing changes must be made by presenting replacement sheets which incorporate the desired changes and which comply with 37 CFR 1.84. An explanation of the changes made must be presented either in the drawing amendments section, or remarks, section of the amendment paper. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). A replacement sheet must include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of the amended drawing(s) must not be labeled as “amended.” If the changes to the drawing figure(s) are not accepted by the examiner, applicant will be notified of any required corrective action in the next Office action. No further drawing submission will be required, unless applicant is notified.
Identifying indicia, if provided, should include the title of the invention, inventor’s name, and application number, or docket number (if any) if an application number has not been assigned to the application. If this information is provided, it must be placed on the front of each sheet and within the top margin.
Annotated Drawing Sheets
A marked-up copy of any amended drawing figure, including annotations indicating the changes made, are required by the examiner. The annotated drawing sheet(s) must be clearly labeled as “Annotated Sheet” and must be presented in the amendment or remarks section that explains the change(s) to the drawings.
Timing of Corrections
Applicant is required to submit acceptable corrected drawings within the time period set in the Office action. See 37 CFR 1.85(a). Failure to take corrective action within the set period will result in ABANDONMENT of the application.
If corrected drawings are required in a Notice of Allowability (PTOL-37), the new drawings MUST be filed within the THREE MONTH shortened statutory period set for reply in the “Notice of Allowability.” Extensions of time may NOT be obtained under the provisions of 37 CFR 1.136 for filing the corrected drawings after the mailing of a Notice of Allowability.
35 U.S.C. 102
► The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that may 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.
35 U.S.C. 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.
► 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 Rejection(s) under 35 U.S.C. 103
► Claim(s) 25-28 and 30-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirkin et al.{US 2010/00811134 – hereinafter “Mirkin”] in view of Olivier [ Mutation Research 373 : 103-110 (2205) – hereinafter “Olivier”] or Husain et al.[US 2018/0066303-- hereinafter “Husain”].
As to Claim 25, Mirkin teaches, see especially Fig. 6B, a immunoassay (i.e. the bio-barcode assay as shown in Fig. 6B) for detecting/processing an analyte which comprises the use of solid support(s) with attached capture agent(s), Ii an anchor oligo attached to a support (i.e. the oligos attached to the small nanoparticles) and iii a hook oligo (i.e. the bio-barcodes) hybridized to the anchor oligo. Mirkin further teaches forming (i.e. generating) a complex which complex comprises an analyte bound to the capture agent and bound detection reagent. That said, Mirkin does not teach strand displacement (i.e. toe-hold strand displacement ) using a labeled detector/displacer oligo(s). Rather, Mirkin teach dehybridizing the bio-barcodes from the complex by heating and detecting the dehybridized bio-barcodes by PCR amplification thereof in order to facilitate detection of an analyte.. However other methods for the displacement and detection of bound probes where known. For example, Olivier teach, see at least Fig. 1, a method in which which bound probes/oligos are dehybridized from hybridization complexes by strand displacement using a primer and the flap exonuclease (i.e. FEN activity of a DNA polymerase to degrade a labeled probe(s) with associated FRET reporting. See also Husain who teach toe-hold strand displacement mediated HCR using the HCR initiator portion of a bound probe to produce a detectable signal indicating the presence of a target analyte in a biological sample
Accordingly, absent an unexpected result it would have been prima facie obvious to the PHOSITA at the time of the invention to modify the method of Mirkin wherein the bio-barcodes of Mirkin is/are detected by an invader assay, as described by Olivier or the HCR described by Husain rather than by PCR as required by Mirkin. Please note that substitution of one known second method/reagent with known properties for a first known method/reagent with known properties would have been prima facie obvious to the ordinary artisan at the time of the invention in the absence of an unexpected result. As regards the motivation to make the substitution recited above, the motivation to combine arises from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. Support for making this obviousness rejection comes from the M.P.E.P. at 2144.07 and 2144.09, as well as, the SCOTUS decision in KSR International. Co. v. Teleflex, Inc., et al., 550 U.S.398 (2007).
As regards Claim(s) 26 and 28, note that both of the metastable HCR molecules of Husain can be labeled, see Fig. 3 and para 58.
Claim(s) 27 is drawn to an embodiment of the method of Claim 25 wherein the method further comprises step(c ) which requires detecting or quantifying the detectable label.
At least Markin teach this limitation see Fig. 6B.
As to Claim 32, note that where the general conditions of a claim are disclosed in the prior art, it is not inventive, in the absence of an unexpected result, to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
► Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirkin in view of Olivier or Husain as applied above against Claim 25 and further in view of Nolan et al. [US 2002/0015962 – hereinafter “Nolan”].
As regards Claim 29, Mirkin in view of Olivier or Husain do not teach detection via flow cytometry as recited by Claim 29, however the detection of nucleic acids (e.g. PCR amplification products) via flow cytometry was known, see for example at least para 35 in Nolan. Accordingly, absent an unexpected result it would have been prima facie obvious to the PHOSITA at the time of the invention to modify the method of Mirkin in view of Olivier or Husain wherein the labeled reporter molecules are detected via flow cytometry rather than by the method disclosed by Mirkin (e.g. microscopy, see at least para 110). Please note that substitution of one known second method/reagent with known properties for a first known method/reagent with known properties would have been prima facie obvious to the ordinary artisan at the time of the invention in the absence of an unexpected result. As regards the motivation to make the substitution recited above, the motivation to combine arises from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. Support for making this obviousness rejection comes from the M.P.E.P. at 2144.07 and 2144.09, as well as, the SCOTUS decision in KSR International. Co. v. Teleflex, Inc., et al., 550 U.S.398 (2007).
Conclusion
C. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ethan Whisenant whose telephone number is (571) 272-0754. The examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm EST or any time via voice mail. If repeated attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anne Gussow, can be reached at (571) 272-6047.
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/ETHAN C WHISENANT/Primary Examiner, Art Unit 1683 ethan.whisenant@uspto.gov
EXAMINER SEARCH NOTES
05-06 DEC 2025 ECW
Databases searched: All available via PE2E SEARCH
CAplus, Medline and BIOSIS via STNext; and Google Scholar (note the search terms used below)
Reviewed the parent(s), if any, and any search(es) performed therein : see the BIB data sheet
Reviewed, the search(es), if any, performed by prior examiners including any international examiners.
Planned Search
Search terms:
All Inventor(s) e.g. Junker D?/au
Immunoassay
DNA or RNA or nucleic or protein$ or antigen$ or peptide$
Detect$
Capture or Capture agent or reagent
Antibod$
Reporter or label$
Anchor oligo$
Hook oligo$
Hybridization
Probe displacement
strand displacement
toe -hold displacement
Solid support substrate bead$ or microbeads or nanobead$
Fluorescent or luminescent or fluorophore$ or lumiphore$
Flow cytometry
► See the Examiner’s PE2E SEARCH notes/strategy in IFW
Application No.: 17/937,724
NOTICE TO COMPLY WITH REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE SEQUENCE AND/OR AMINO ACID SEQUENCE DISCLOSURES
The nucleotide and/or amino acid sequence disclosure contained in this application does not comply with the requirements for such a disclosure as set forth in 37 C.F.R. 1.821 - 1.825 for the following reason(s):
■ 1. This application clearly fails to comply with the requirements of 37 C.F.R. 1.821-1.825. Applicant’s attention is directed to these regulations, published at 1114 OG 29, May 15, 1990 and at 55 FR 18230, May 1, 1990.
■ 2. This application does not contain, as a separate part of the disclosure on paper copy,
a “Sequence Listing” as required by 37 C.F.R. 1.821(c).
■ 3. A copy of the “Sequence Listing” in computer readable form has not been submitted as required by 37 C.F.R. 1.821(e).
□ 4. A copy of the “Sequence Listing” in computer readable form has been submitted. However, the content of the computer readable form does not comply with the requirements of 37 C.F.R. 1.822 and/or 1.823, as indicated on the attached copy of the marked-up “Raw Sequence Listing.”
□ 5. The computer readable form that has been filed with this application has been found to be damaged and/or unreadable as indicated on the attached CRF Diskette Problem Report. A Substitute computer readable form must be submitted as required by 37 C.F.R. 1.825(d).
□ 6. The paper copy of the “Sequence Listing” is not the same as the computer readable from of the “Sequence Listing” as required by 37 C.F.R. 1.821(e).
■ 7. Other: The sequences in Figure 18 are not accompanied by their corresponding SEQ ID NOs. as required.
Applicant Must Provide:
■ An initial or substitute computer readable form (CRF) copy of the “Sequence Listing”.
■ An initial or substitute paper copy of the “Sequence Listing”, as well as, an amendment directing its entry into the specification.
■ A statement that the content of the paper and computer readable copies are the same and, where applicable, include no new matter, as required by 37 C.F.R. 1.821(e) or 1.821(f) or 1.821(g) or 1.825(b) or 1.825(d).
■ Amend the specification and/or the drawings to include the required SEQ ID NOs.