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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 24 June 2026 is acknowledged.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 June 2026.
Claims 1-7 are also withdrawn from further consideration because they were amended in the amendment to the claims filed 24 June 2026 to recite methods that are directed to the nonelected invention of Group II. In the Requirement for Restriction mailed 26 May 2026, claims 1-7 were interpreted as being product claims because they described structural requirements of the compound (e.g. “a fluorescence dye with a high Stokes shift”) and did not include method steps. Therefore, the amendment has amended the claims from being directed to a product of Group I to being directed to a method of the nonelected Group II.
Information Disclosure Statement
The information disclosure statement (IDS) filed 29 August 2024 is considered, initialed, and attached hereto. Regarding Foreign Patent Document Cite No B, EP 2 652 154 A1, this document is not present and has only been considered insofar as the corresponding application WO2012083235A1 that is present teaches the same subject matter.
Claim Status
Claims 1-13 are pending.
Claims 1-10 are withdrawn (see Election/Restriction section above).
Claims 11-13 are under examination.
Drawings
The drawings are objected to because page 12 labels the views on the page as FIG. 11C and FIG. 11D as well as “Figure 12” on the bottom of the page. Similarly, page 18 labels the views on the page as FIG. 14A and FIG. 14B as well as “Figure 15” on the bottom of the page. The numbering of views must comply with 37 C.F.R. 1.84(u):
(u) Numbering of views.
(1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.
(2) Numbers and letters identifying the views must be simple and clear and must not be used in association with brackets, circles, or inverted commas. The view numbers must be larger than the numbers used for reference characters.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should 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 an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of terms including, but not limited to, Cy, QIAxcel, QuBit, PicoGreen, Alexa Fluor, Quasar, ATTO, and Tye, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
Claims 11-13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “large enough to skip at least one emission filter channel” in claim 11 lines 3-4 and claim 13 lines 3-4 is a relative term which renders the claims indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention because “large” itself is a relative term and because what it means to “skip at least one emission filter channel” is not defined and may vary depending on the filters used. This would be resolved by defining in the claim a specific minimum Stokes shift, such as in the specification at [0050] where it recites “The high Stokes shifts dyes of this invention have a Stokes shift of at least 60 nm”. Claim 12 is also indefinite because it recites the composition of claim 11.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 11 and 13 in line 8 of each claim recite the broad recitation “bivalent ions”, and the claims also recites “preferably Mg2+ ions” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 12 is also indefinite because it recites the composition of claim 11.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim recites a “Use”, which is not a process, machine, manufacture, or composition of matter.
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 11-13 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Yan (WO 2012/083235, published 21 June 2012, effectively filed 16 December 2010).
Regarding claim 11, Yan teaches a composition comprising:
at least one fluorescent dye with a high Stokes shift, wherein the high Stokes shift is at least large enough to skip at least one emission filter channel (“pre-mixes contain a concentration of a fluorescent dye with a long Stokes-shift as described elsewhere herein” [0053]; “In some embodiments, the Stokes shift (the difference between the excitation and emission wavelength maximum) of the dye is at least, e.g., 60, 75, 100, 150 nm or more” [0078]),
a heat-resistant DNA polymerase (“pre-mixes can further contain one or more reagents useful and/or required for amplification or detection of the sample. Exemplary possible reagents include […] one or more nucleic acid polymerase” [0055]; Exemplary DNA polymerases are thermostable polymerases, which are especially useful in PCR” [0064]),
mixture of dNTPs (“Nucleotide bases useful in the present invention can be any nucleotide useful in the polymerization of a nucleic acid […] In some embodiments, the nucleotides are deoxynucleoside triphosphates, dNTPs” [0057]),
a PCR buffer solution (“Exemplary possible reagents include […] one or more buffer” [0055]) and
bivalent ion, preferably Mg2+ ions (“Exemplary possible reagents include […] one or more salt” [0055]; “Exemplary salt solutions include […] magnesium chloride” [0059], magnesium chloride contains the Mg2+ bivalent ion).
Regarding claim 12, Yan teaches the composition of claim 11 (see 35 U.S.C. 102 rejection of claim 11 above) as a master mix (“The present invention provides for amplification "pre-mixes", i.e., aqueous or reconstituted mixtures of reagents sufficient to be used in amplification with addition of the sample only, or the sample and primers and/or probes, and optionally minimal or no other reagents” [0053], the recited pre-mix is equivalent to a claimed master mix).
Regarding claim 13, Yan teaches a kit for performing PCR reactions comprising the limitations listed in a) through e) that are equivalent to the limitations of the composition of claim 11 (see 35 U.S.C. 102 rejection above; “The present invention also provides kits for making or using the pre-mixes as described herein” [0093]). The recitation in line 1 of claim 13 “for performing multiplex PCR reactions” is a statement of the intended use of the kit in the preamble of the claim. MPEP §2111.02(II) states: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. As the body of claim 13 fully and intrinsically sets forth the limitations of the claimed kit and the above identified recitation in the preamble merely states an intended use of the invention, the intended use does not limit the scope of the claim. Even if the intended use were interpreted as resulting in a structural difference in the claimed invention and therefore limiting, a prior art structure only has to be capable of performing the intended use to meet the claim (see MPEP §2111.02(II)). The kit taught by Yan would be capable of being used for multiplex PCR, and therefore anticipates claim 13 even if the intended use were interpreted as limiting.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0230515, published 16 August 2018, teaches dPCR using dyes with large Stokes shifts.
WO 2022/136477, effectively filed 22 December 2020, teaches multiplexed PCR using dyes with large Stokes shifts.
Chakravorty et al. (“Detection of Isoniazid-, Fluoroquinolone-, Amikacin-, and Kanamycin-Resistant Tuberculosis in an Automated, Multiplexed 10-Color Assay Suitable for Point-of-Care Use” J Clin Microbiol 55(1), pages 183-198 (2016)) teaches multiplexed PCR using dyes with large Stokes shifts.
Conclusion
Claims 11-13 are rejected. Claims 1-10 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey Lawrence Bellah whose telephone number is (571)272-1024. The examiner can normally be reached M-Th, 7:30-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY BELLAH/Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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