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 .
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 16, 18, 23-30 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 15, 17, 22-29 of prior U.S. Patent No. 11,512,342. This is a statutory double patenting rejection.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 18 of U.S. Patent No. 11,512,342. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a composition comprising an enzyme that releases pyrophosphate from a substrate and a dye of identical Formula 1.
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)(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.
Claim(s) 1-2, 5, 7-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cekan et al. WO2022/101259 (Effective filing date 10 November 2020).
With regards to claims 1 and 2, Cekan et al. teaches a composition comprising an enzyme that release pyrophosphate from substrate and dye of Formula 1 wherein R1 is halogen, R5 is H, R2 and R3 are lower alkyl wherein one of them comprises a terminal sulfonate and R4 is OH. (pages 17-18; [91], [109]; page 27; Fig. 3A).
With regards to claim 5, Cekan et al. teaches a composition further comprises one or more nucleoside triphosphates (page 27 section 39-41).
With regards to claim 7, Cekan et al. teaches a composition of claim 1, wherein the dye is 5-Br-PAPS. (Pages 17-18).
With regards to claims 8, Cekan et al. teaches a composition of claim 1, wherein the enzyme is DNA polymerase, RNA polymerase, or reverse transcriptase [51-53].
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.
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(s) 1-8, 16, 18-19, 23-27, 29, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cekan et al. WO2022/101259 (Effective filing date 10 November 2020) in view of Tanner et al. US 20210285065.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
With regards to claims 1 and 2, Cekan et al. teaches a composition comprising an enzyme that release pyrophosphate (PPi) from substrate and dye of Formula 1 wherein R1 is halogen, R5 is H, R2 and R3 are lower alkyl wherein one of them comprises a terminal sulfonate and R4 is OH. (pages 17-18; [91], [109]; page 27; Fig. 3A).
With regards to claim 5, Cekan et al. teaches a composition further comprises one or more nucleoside triphosphates (page 27 section 39-41).
With regards to claim 7, Cekan et al. teaches a composition of claim 1, wherein the dye is 5-Br-PAPS. (Pages 17-18).
With regards to claims 8, Cekan et al. teaches a composition of claim 1, wherein the enzyme is DNA polymerase, RNA polymerase, or reverse transcriptase [51-53].
Cekan et al. teaches Zn²⁺/5-Br-PAPS detection reagent changes color during DNA amplification due to PPi (produced as a side-product of dNTP hydrolysis by a polymerase) competing with 5-Br-PAPS to bind Zn²⁺ (Fig. 3A). As amplification progresses, PPi accumulates and the increasing concentration of PPi progressively shifts the Zn²*/5-Br-PAPS complex (magenta) to free 5-Br-PAPS (orange-yellow) and zinc(II) pyrophosphate. This mechanism was readily demonstrated under target assay conditions (maximum PPi production ~5 mM) by preparing mock samples containing base LAMP reaction mix components (20 mM Tris-HCI pH=7.9, 20 mM KCI, 60 mM GuCl, 9 mM MgSO4, 0.1% Tween-20, 0.05% Triton X-100), 25 or 50 µM Zn²*/5-Br-PAPS detection reagent and sodium pyrophosphate (concentration range of 0-5 mM) (pages 30-32). Cekan also teaches kits (see abstract).
However, Cekan et al. does not teach manganese ions.
Tanner teaches master mix containing a metallochromic indicator dye used in an amplification reaction that alters the availability of one or more metal ions in the reaction mix, the spectral or fluorescent properties of the dye change (e.g. the dye changes color), which provides confirmation that amplification has occurred. In one embodiment, the metallochromic indicator dye is 4-(2-pyridylazo) resorcinol (PAR). If PAR is used, the master mix may additionally comprise manganese ions such that the PAR in the master mix is complexed with manganese ions to form a PAR-Mn complex [0007].
With regards to claim 6, Tanner provides a master mix comprising: a DNA polymerase suitable for isothermal amplification of DNA; dNTPs (dATP, dGTP, dCTP, and dTTP); and at least one dye that changes color or fluorescence in response to DNA amplification. In many embodiments, the master mix is a Loop-Mediated Isothermal Amplification (LAMP) master mix. [0003]. … The master mix may be concentrated so that when added to the template, the components in the master mix are in the appropriate amounts in the reaction mix [0043]… The master mix may be prepared in a 2×, 3×, 4×, 5×, 10× or any suitable concentration [0140].
Tanner teaches the method uses PAR as the dye, and the master mix or the reaction mixture further comprises manganese ions (e.g. about 0.4 mM Mn ions per 100 μM PAR) (this is viewed as molar ratio manganese salt to dye greater than 1). Complex of PAR with manganese ions is in a red-colored state. Pyrophosphate produced during the nucleic acid amplification process, as a byproduct of primer nucleic acid polymerization, sequesters manganese with a higher affinity than does PAR, thereby removing the manganese from solution and returning PAR to a non-complexed, yellow-colored state [0023]. By including a small amount of manganese ions in an amplification reaction, PAR is initially complexed with the metal and therefore in a red-colored state. The pyrophosphate by-product sequesters manganese with a higher affinity than does PAR, resulting in the dissociation of Mn from PAR and thereby returning PAR to a yellow-colored state. Tanner teaches that because pyrophosphate exhibits a higher affinity for manganese ions than PAR, this property can be used to detect amplification of nucleic acids using LAMP. Pyrophosphate generated during nucleic acid polymerization precipitates manganese from solution, thus disrupting the PAR:Mn complex and restoring the yellow color. Tanner teaches a color change is observed when precipitation of manganese occurs that is caused by the release of pyrophosphate in a LAMP reaction [0070-0080]. Tanner teaches the change in the spectral or fluorescent properties of the dye can be detected by eye or using a spectrophotometer or fluorimeter or recorded by means of a camera or other color sensitive recording device [0029]. Tanner teaches individual samples were tested in strip well tubes or 96 well plates with positive and negative outcomes observed by eye, and also with a spectrophotometer (SpectraMax) using dual wavelengths that captured signal from 560 nm (red) to 432 nm (yellow) from each 384 well plate ([0178] see also [0106]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Manganese ions as taught by Tanner for the composition and method of Cekan et al. One of ordinary skill in the art would have been motivated to modify the primary reference in the manner of the claims, without exercising inventive skill, to achieve the expected benefits, optimizations and/or expanded applications as this is well known practice in the art. Tanner teaches “By including a small amount of manganese ions in an amplification reaction, PAR is initially complexed with the metal and therefore in a red-colored state. The pyrophosphate by-product sequesters manganese with a higher affinity than does PAR, resulting in the dissociation of Mn from PAR and thereby returning PAR to a yellow-colored state and because pyrophosphate exhibits a higher affinity for manganese ions than PAR, this property can be used to detect amplification of nucleic acids. And Cekan et al. teaches that preferred examples of metallochromic indicators are those which are able to bind metal ions, preferably transition metal ions or post-transition metal ions. Examples of preferred metallochromic indicators are PAN, PAR, PAN/PAR derivatives, 2-(5-Bromo-2-pyridylazo)-5-[N-propyI-N-(3-sulfopropyl)amino]phenol (5-Br-PAPS) (pages 16-18).
MPEP states wherein the “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Alter, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Routine optimization is not considered inventive and no evidence has been presented that the selection of a metallochromic indicators and metal ions was other than routine, that the products resulting from the optimization have any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEZIA RILEY whose telephone number is (571)272-0786. The examiner can normally be reached 7:30-6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEZIA RILEY/Primary Examiner, Art Unit 1681 6 June 2026
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