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 .
Applicant’s preliminary amendment filed on January 16, 2024 is acknowledged. Claims 19-34 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 16, 2024 has been considered by the examiner.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 18-34 are rejected under 35 U.S.C. 103 as being unpatentable over Petralia et al., (Colloids and Surfaces Biointerfaces, 2020, 187, p. 1-8 IDS on 8/16/2024) in view of Liu et al (WO 2004/046369 in IDS on 8/16/2024) and Petralia et al., (Analyst 2017, Vol. 142, p. 2090-2093 in IDS on 8/16/2024).
Petralia (Colloids and Surfaces Biointerfaces, 2020) teaches a method of detecting HBV virus in a sample, comprising: contacting the sample containing the whole HBV genome with at least two single-strand nucleic acid probes identical with present SEQ ID NO: 1 and SEQ ID NO: 2, wherein each of the at least two single-strand nucleic acid probes is complementary to a corresponding portion of the target whole genome (see page 2, right paragraph).
Petralia (Analyst 2017) teaches the method comprising contacting the target genomic DNA with two thiol 5'-terminated specific probes chemically-grafted onto a miniaturised Pt-working electrode surface and adding a redox intercalative Os-complex ([Os(bpy)₂DPPZ]Cl₂). The probes were properly designed to recognize specific genetic sequences on both the parallel and anti-parallel strands of the same target genome. Moreover, to guarantee the simultaneous hybridization with the two strands of the genome target, a sequence gap of 138 bps between the two probes was maintained to permit an efficient genome folding on the electrode surface, increasing the hybridization product stability (Fig. 1, p. 2091, left-hand col. par. 3). The method was tested for the detection of HBV genomic DNA fro human blood (Fig. 3).
Neither Petralia (Analyst 2017) nor Petralia (Colloids and Surfaces Biointerfaces, 2020) do not teach adding an clectrochemiluminescence (ECL) active luminophore; and c) determining a luminescent signal generated by the ECL active luminophore; wherein the target whole genome is selected from a DNA or RNA genome.method for an electrochemical detection of a pathogen genome without any amplification step.
Liu teaches a system for detecting a target nucleic acid sequence using clectrochemiluminescence (ECL) comprising: a support comprising an electrode and a nucleic acid probe attached thereto, wherein the nucleic acid probe comprises a sequence complementary to the target nucleic acid sequence; a non-covalent photoelectrochemical label - which is the same as ECL (p. 3 par. 1) - for contacting with the nucleic acid probe; a light source for irradiating the nucleic acid probe; and a data collection controller for measuring a current at the electrode (cl. 1), wherein the non-covalent photoelectrochemical label can be [Ru(bpy)₃]²⁺ [Ru(bpy)₂dppz]²⁺ or [Ru(phen)₃]²+ (see claim 10).
Liu teaches discloses the use of a sacrificial reductant to induce the redox reaction such a a tertiary amine or tripropylamine (claims 13, 14).
It would have been prima facie obvious to provide the method of Petralia using Liu’s ECL as an alternative to electrochemistry, especially when the same class of compounds was to be used, for the organism detection method
At the time of filing, the skilled person was well aware of the fact that intercalative compounds containing transition metal ions such as Ru(III) or Os(II) (specifically RU(III) complexes with DPPZ) had luminescent properties and could be used as labels for ECL-based DNA detection.
Regarding present claims 26-28. Petralia (Colloids and Surfaces Biointerfaces, 2020) teaches methods for detecting HBV in the sample comprising using the probes identical with present SEQ ID NO: 1 and SEQ ID NO: 2 (see page 2, right paragraph).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Pertinent references
Jiang et al. (US Patent 10,036,062) teach a sequence identical with present SEQ ID NO: 1 (see SEQ ID NO: 1 in
Query Match 100.0%; Score 18; Length 19;
Best Local Similarity 100.0%;
Matches 18; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GGTGAGTGATTGGAGGTT 18
||||||||||||||||||
Db 19 GGTGAGTGATTGGAGGTT 2
Loeffert et al. (US Patent 8,486,628) teach a sequence identical with present SEQ ID NO: 2 (see SEQ ID NO: 4 in
Query Match 100.0%; Score 18; Length 21;
Best Local Similarity 100.0%;
Matches 18; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CACATCAGGATTCCTAGG 18
||||||||||||||||||
Db 1 CACATCAGGATTCCTAGG 18
Double Patenting
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 18-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/851,095.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to A method of detecting an analyte in a sample, wherein the analyte is a target whole genome of an organism, comprising:
a) contacting the sample containing the whole genome with at least two single-strand nucleic acid probes wherein each of the at least two single-strand nucleic acid probes is complementary to a corresponding portion of the target whole genome;
b) adding an clectrochemiluminescence (ECL) active luminophore; and
c) determining a luminescent signal generated by the ECL active luminophore; wherein the target whole genome is selected from a DNA or RNA genome.
The claims of the Application No. 18/851,095 are drawn to A process for detecting an analyte in an isolated sample, wherein said analyte is a target nucleic acid, comprising the steps of:
a) providing an isolated sample comprising at least one nucleic acid;
b) heat-treating said isolated sample thus obtaining a heat-treated sample;
c) contacting said heat-treated sample with at least two single-stranded nucleic acid probes, each of said at least two single-stranded nucleic acid probes being complementary to a corresponding portion of said target nucleic acid; d) adding an active luminescent luminophore;
e) determining a luminescence signal generated by said active luminophore.
The present claims and the claims of the copending Application are drawn to similar methods of detecting a virus particle using luminescence signal.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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