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 .
The preliminary amendment filed March 13, 2024, canceling claims 1-24 and adding new claims 25-61 is acknowledged and has been entered.
Claims 25-61 are pending and will be examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 26, 2024, June 24, 2024, July 22, 2024, February 17, 2025, March 5, 2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 § 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 25-64 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11884969 (‘969 patent herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 11884969 represent a species of the current claims and this species anticipates the current, more generic claims. Both sets of claims teach methods for detecting a target nucleic acid sequence in a sample comprising the steps of amplifying a target nucleic acid sequence in a sample under an isothermal condition, wherein the target nucleic acid sequence comprises a first strand and a second strand complementary to each other, and wherein the amplifying comprises contacting a double-stranded nucleic acid comprising the target nucleic acid sequence with a first primer and a second primer capable of hybridizing to the first and second strands of the target nucleic acid sequence, respectively, and an enzyme having a hyperthermophile polymerase activity to generate a nucleic acid amplification product that comprises the sequence of the first primer or the reverse complement thereof, and the sequence of the second primer or the reverse complement thereof, and a spacer sequence of 1 to 10 bases long flanked by the sequences of the primers, and detecting the nucleic acid amplification product in 20 minutes or less from the time the double-stranded nucleic acid is contacted with the primers and the enzyme having a hyperthermophile polymerase, wherein the method does not comprise using any enzymes that are not a polymerase.
Further, compare claims 27-36 of the instant claims to claims 3-13 of ‘969 patent. Each set of claims cover the same subject matter including nucleic acid sample source, features of the enzymes included and steps of the method. Both sets of claims depend from a method that shares the features as described above and therefore the instant claims are not patentably distinct.
Claims 25-64 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11118219 (‘219 patent herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 11118219 represent a species of the current claims and this species anticipates the current, more generic claims. Both sets of claims teach methods for detecting a target nucleic acid sequence in a sample comprising the steps of amplifying a target nucleic acid sequence in a sample under an isothermal condition, wherein the target nucleic acid sequence comprises a first strand and a second strand complementary to each other, and wherein the amplifying comprises contacting a double-stranded nucleic acid comprising the target nucleic acid sequence with a first primer and a second primer capable of hybridizing to the first and second strands of the target nucleic acid sequence, respectively, and an enzyme having a hyperthermophile polymerase activity to generate a nucleic acid amplification product that comprises the sequence of the first primer or the reverse complement thereof, and the sequence of the second primer or the reverse complement thereof, and a spacer sequence of 1 to 10 bases long flanked by the sequences of the primers, and detecting the nucleic acid amplification product in 20 minutes or less from the time the double-stranded nucleic acid is contacted with the primers and the enzyme having a hyperthermophile polymerase, wherein the method does not comprise using any enzymes that are not a polymerase.
Further, compare claims 27-35 of the instant claims to claims 3-10 of ‘219 patent. Each set of claims cover the same subject matter including nucleic acid sample source, features of the enzymes included and steps of the method. Both sets of claims depend from a method that shares the features as described above and therefore the instant claims are not patentably distinct.
Claims 25-64 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11299777 (‘777 patent herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 11299777 represent a species of the current claims and this species anticipates the current, more generic claims. Both sets of claims teach methods for detecting a target nucleic acid sequence in a sample comprising the steps of amplifying a target nucleic acid sequence in a sample under an isothermal condition, wherein the target nucleic acid sequence comprises a first strand and a second strand complementary to each other, and wherein the amplifying comprises contacting a double-stranded nucleic acid comprising the target nucleic acid sequence with a first primer and a second primer capable of hybridizing to the first and second strands of the target nucleic acid sequence, respectively, and an enzyme having a hyperthermophile polymerase activity to generate a nucleic acid amplification product that comprises the sequence of the first primer or the reverse complement thereof, and the sequence of the second primer or the reverse complement thereof, and a spacer sequence of 1 to 10 bases long flanked by the sequences of the primers, and detecting the nucleic acid amplification product in 20 minutes or less from the time the double-stranded nucleic acid is contacted with the primers and the enzyme having a hyperthermophile polymerase, wherein the method does not comprise using any enzymes that are not a polymerase.
Further, compare claims 27-35 of the instant claims to claims 3-15 of ‘777 patent. Both sets of claims depend from a method that shares the features as described above and therefore the instant claims are not patentably distinct.
Claims 25-64 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 9617587 (‘587 patent herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 9617587 represent a species of the current claims and this species anticipates the current, more generic claims. Both sets of claims teach methods for detecting a target nucleic acid sequence in a sample comprising the steps of amplifying a target nucleic acid sequence in a sample under an isothermal condition, wherein the target nucleic acid sequence comprises a first strand and a second strand complementary to each other, and wherein the amplifying comprises contacting a double-stranded nucleic acid comprising the target nucleic acid sequence with a first primer and a second primer capable of hybridizing to the first and second strands of the target nucleic acid sequence, respectively, and an enzyme having a hyperthermophile polymerase activity to generate a nucleic acid amplification product that comprises the sequence of the first primer or the reverse complement thereof, and the sequence of the second primer or the reverse complement thereof, and a spacer sequence of 1 to 10 bases long flanked by the sequences of the primers, and detecting the nucleic acid amplification product in 20 minutes or less from the time the double-stranded nucleic acid is contacted with the primers and the enzyme having a hyperthermophile polymerase, wherein the method does not comprise using any enzymes that are not a polymerase.
Further, compare claims 41-44 of the instant claims to claims 10-14 of ‘587 patent, for example. Instant claims 41-44 cover the same subject matter, including incubation temperatures and sequence lengths, across both sets of claims. Both sets of claims depend from a method that shares the features as described above and therefore the instant claims are not patentably distinct.
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.
Claim(s) 25-34, 37-59 and 61 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tan et al. (Biochemistry, 2008, 47, 9987-9999).
With regard to claim 25, Tan teaches a method for detecting a target nucleic acid sequence in a sample, the method comprising:
(a) amplifying a target nucleic acid sequence compnsmg a first strand and a second strand complementary to each other in an isothermal amplification condition, wherein the amplifying comprises contacting a nucleic acid comprising the target nucleic acid sequence with:
i) a first primer and a second primer, wherein the first primer is capable of hybridizing to a sequence of the first strand of the target nucleic acid sequence,
and the second primer is capable of hybridizing to a sequence of the second strand of the target nucleic acid sequence; and
ii) an enzyme having a hyperthermophile polymerase activity, thereby generating a nucleic acid amplification product at detectable levels within 20 minutes, wherein the nucleic acid amplification product comprises (Abstract, p 9988, col. 1, p 9989, col. 1, where the amplification can occur within 10 or 20 minutes):
(1) the sequence of the first primer or a portion thereof, or the reverse complement thereof,
(2) the sequence of the second primer or a portion thereof, or the reverse complement thereof, and
(3) a spacer sequence flanked by (1) and (2), wherein the spacer sequence is 1 to 10 bases long; and
wherein the amplifying does not comprise using an additional nicking enzyme; and
(b) detecting the nucleic acid amplification product (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 26, Tan teaches a method of claim 25, wherein step (b) further comprises determining the amount of the nucleic acid that comprises the target nucleic acid sequence in the sample (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 27, Tan teaches a method of claim 25, wherein the nucleic acid is a genomic nucleic acid, a plasmid nucleic acid, a mitochondrial nucleic acid, a cellular nucleic acid, or an extracellular nucleic acid (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 28, Tan teaches a method of claim 25, wherein the nucleic acid is a bacterial nucleic acid, a viral nucleic acid, a fungal nucleic acid, a protist nucleic acid, a plant nucleic acid, a nonhuman animal nucleic acid, or a human nucleic acid (p 9990, results heading, where genomic DNA is detected).
With regard to claim 29, Tan teaches a method of claim 25, wherein the target nucleic acid sequence is a bacterial nucleic acid or a viral nucleic acid (p 9990, results heading, where genomic DNA is detected).
With regard to claim 30, Tan teaches a method of claim 25, further comprising before step (a), generating the nucleic acid by a reverse transcription reaction from a sample RNA using a reverse transcriptase (p 9990 results heading, where RNA is detected using real time fluorescent monitoring).
With regard to claim 31, Tan teaches a method of claim 30, wherein the sample RNA is a cellular RNA, a mRNA, a microRNA, a bacterial RNA, or a viral RNA (p 9990 results heading, where RNA is detected using real time fluorescent monitoring).
With regard to claim 32, Tan teaches a method of claim 30, comprising contacting the sample RNA with the reverse transcriptase and the enzyme having a hyperthermophile polymerase activity simultaneously (p 9990 results heading, where RNA is detected using real time fluorescent monitoring).
With regard to claim 33, Tan teaches a method of claim 30, comprising contacting the sample RNA with the reverse transcriptase, the enzyme having a hyperthermophile polymerase activity, the first primer, and the second primer simultaneously (p 9990 results heading, where RNA is detected using real time fluorescent monitoring).
With regard to claim 34, Tan teaches a method of claim 25, wherein the enzyme having a hyperthermophile polymerase activity has a reverse transcriptase activity (p 9990 results heading, where RNA is detected using real time fluorescent monitoring).
With regard to claim 37, Tan teaches a method of claim 25, wherein the enzyme having a hyperthermophile polymerase activity has 10% or less exonuclease activity compared to an unmodified hyperthermophile polymerase (p 9990 results heading, where RNA is detected using real time fluorescent monitoring).
With regard to claim 38, Tan teaches a method of claim 25, wherein the sample is a specimen obtained or derived from a human, a non-human animal, a plant, a bacterium, a fungus, a virus, a protist, or a mixture thereof (p 9990, results heading, where human genomic DNA is detected).
With regard to claim 39, Tan teaches a method of claim 25, wherein the sample is a bodily fluid sample, a tissue sample, or a mixture thereof from a human subject (p 9990, results heading, where human genomic DNA is detected).
With regard to claim 40, Tan teaches a method of claim 25, wherein the method does not comprise contacting the nucleic acid with a single-stranded DNA binding protein prior to or during step (a) (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 41, Tan teaches a method of claim 25, wherein amplifying the target nucleic acid sequence is performed at a constant temperature of about 55 degrees Celsius to about 75 degrees Celsius (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described and includes incubation at 55oC).
With regard to claim 42, Tan teaches a method of claim 25, wherein amplifying the target nucleic acid sequence is performed at a constant temperature of about 65 degrees Celsius (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 43, Tan teaches a method of claim 25, wherein the first primer, the second primer, or both is about 8 to 16 bases long (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 44, Tan teaches a method of claim 25, wherein the nucleic acid amplification product is about 20 to 40 bases long (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 45, Tan teaches a method of claim 25, wherein the spacer sequence comprises a portion of the target nucleic acid sequence (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 46, Tan teaches a method of claim 25, wherein the spacer sequence is 1 to 5 bases long (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 47, Tan teaches a method of claim 25, further comprising contacting the nucleic acid amplification product with a signal-generating oligonucleotide capable of hybridizing to the amplification product, wherein the single-generating oligonucleotide comprises a fluorophore, a quencher, or both (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 48, Tan teaches a method of claim 47, wherein the detecting the nucleic acid amplification product comprises detecting a fluorescent signal (p 9990 results heading, where RNA is detected using real time fluorescent monitoring).
With regard to claim 49, Tan teaches a method of claim 25, wherein the first primer, the second primer, or both comprise one or more of DNA bases, modified DNA bases, or a combination thereof (p 9990 results heading, where RNA is detected using real time fluorescent monitoring).
With regard to claim 50, Tan teaches a method of claim 25, wherein the nucleic acid is a double-stranded DNA (p 9990 results heading, where RNA is detected using real time fluorescent monitoring; Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described)).
With regard to claim 51, Tan teaches a method of claim 25, wherein the method is performed in a single reaction vessel (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 52, Tan teaches a method of claim 25, compnsmg generating a nucleic acid amplification product at detectable levels within 15 minutes (Abstract, p 9988, col. 1, p 9989, col. 1, where the amplification can occur within 10 or 20 minutes).
With regard to claim 53, Tan teaches a composition for amplifying a target nucleic acid sequence under an isothermal amplification condition, the composition comprising: a nucleic acid comprising the target nucleic acid sequence having a first strand and a second strand complementary to each other (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described);
a first primer and a second primer, wherein the first primer is capable of hybridizing to a
sequence of the first strand of the target nucleic acid sequence, and the second primer is capable
of hybridizing to a sequence of the second strand of the target nucleic acid sequence; and
an enzyme having a hyperthermophile polymerase activity and capable of generating a nucleic acid amplification product under an isothermal amplification condition, the nucleic acid
amplification product comprising,
(1) the sequence of the first primer or a portion thereof, or the reverse complement thereof,
(2) the sequence of the second primer or a portion thereof, or the reverse complement thereof, and
(3) a spacer sequence flanked by (1) and (2), wherein the spacer sequence is 1 to 10 bases long.
wherein the composition does not comprise an additional nicking enzyme (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 54, Tan teaches a composition of claim 53, further comprising the nucleic acid amplification product (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 55, Tan teaches a composition of claim 53, wherein the spacer sequence is 1 to 5 bases long (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 56, Tan teaches a composition of claim 53, wherein the spacer sequence comprises a portion of the target nucleic acid sequence (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 57, Tan teaches a composition of claim 53, wherein the nucleic acid is a bacterial nucleic acid, a viral nucleic acid, a fungal nucleic acid, a protist nucleic acid, a plant nucleic acid, a nonhuman animal nucleic acid, or a human nucleic acid (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 58, Tan teaches a composition of claim 53, wherein the nucleic acid is a genomic nucleic acid, a plasmid nucleic acid, a mitochondrial nucleic acid, a cellular nucleic acid, or an extracellular nucleic acid (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
With regard to claim 59, Tan teaches a composition of claim 53, wherein the nucleic acid is a double-stranded DNA (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described)
With regard to claim 61, Tan teaches a composition of claim 53, wherein the first primer, the second primer, or both is about 8 to 16 bases long (Abstract, Fig 1 and legend, see also p. 9988, where the EXPAR method is described).
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) 35-36 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al. (Biochemistry, 2008, 47, 9987-9999) as applied over claims 25-34, 37-59 and 61 above and further in view of Sorge et al. (US Patent 8,268,605; September 2012).
With regard to claim 35, Sorge teaches a method of claim 25, wherein the enzyme having a hyperthermophile polymerase activity has an amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID NO:8 or a functional fragment thereof ((see Abstract and column 7, lines 49-65. In addition, Sorge teaches the amino acid sequence of the DNA polymerase from Thermococcus Sp. strain 9°N-7, and that conservative mutations may be made that lead to reduced exonuclease activity (columns 31-32 and column 51, lines 2-22). This amino acid sequence (775 amino acids) is identical to claimed SEQ ID NO: 8, also identified asstrain 9°N-7 (see below)).
With regard to claim 36, Sorge teaches a method of claim 25, wherein the enzyme having a hyperthermophile polymerase activity is a polymerase comprising the amino acid sequence of SEQ ID NO: 8 (see Abstract and column 7, lines 49-65. In addition, Sorge teaches the amino acid sequence of the DNA polymerase from Thermococcus Sp. strain 9°N-7, and that conservative mutations may be made that lead to reduced exonuclease activity (columns 31-32 and column 51, lines 2-22). This amino acid sequence (775 amino acids) is identical to claimed SEQ ID NO: 8, also identified as strain 9°N-7 (see above)).
With regard to claim 60, Sorge teaches a method of claim 53, wherein the enzyme having a hyperthermophile polymerase activity has an amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID NO:8 or a functional fragment thereof or a polymerase comprising the amino acid sequence of SEQ ID NO: 8 ((see Abstract and column 7, lines 49-65. In addition, Sorge teaches the amino acid sequence of the DNA polymerase from Thermococcus Sp. strain 9°N-7, and that conservative mutations may be made that lead to reduced exonuclease activity (columns 31-32 and column 51, lines 2-22). This amino acid sequence (775 amino acids) is identical to claimed SEQ ID NO: 8, also identified as strain 9°N-7 (see above).
Qy 1 MILDTDYITENGKPVIRVFKKENGEFKIEYDRTFEPYFYALLKDDSAIEDVKKVTAKRHG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MILDTDYITENGKPVIRVFKKENGEFKIEYDRTFEPYFYALLKDDSAIEDVKKVTAKRHG 60
Qy 61 TVVKVKRAEKVQKKFLGRPIEVWKLYFNHPQDVPAIRDRIRAHPAVVDIYEYDIPFAKRY 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TVVKVKRAEKVQKKFLGRPIEVWKLYFNHPQDVPAIRDRIRAHPAVVDIYEYDIPFAKRY 120
Qy 121 LIDKGLIPMEGDEELTMLAFDIETLYHEGEEFGTGPILMISYADGSEARVITWKKIDLPY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LIDKGLIPMEGDEELTMLAFDIETLYHEGEEFGTGPILMISYADGSEARVITWKKIDLPY 180
Qy 181 VDVVSTEKEMIKRFLRVVREKDPDVLITYNGDNFDFAYLKKRCEELGIKFTLGRDGSEPK 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VDVVSTEKEMIKRFLRVVREKDPDVLITYNGDNFDFAYLKKRCEELGIKFTLGRDGSEPK 240
Qy 241 IQRMGDRFAVEVKGRIHFDLYPVIRRTINLPTYTLEAVYEAVFGKPKEKVYAEEIAQAWE 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 IQRMGDRFAVEVKGRIHFDLYPVIRRTINLPTYTLEAVYEAVFGKPKEKVYAEEIAQAWE 300
Qy 301 SGEGLERVARYSMEDAKVTYELGREFFPMEAQLSRLIGQSLWDVSRSSTGNLVEWFLLRK 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 SGEGLERVARYSMEDAKVTYELGREFFPMEAQLSRLIGQSLWDVSRSSTGNLVEWFLLRK 360
Qy 361 AYKRNELAPNKPDERELARRRGGYAGGYVKEPERGLWDNIVYLDFRSLYPSIIITHNVSP 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 AYKRNELAPNKPDERELARRRGGYAGGYVKEPERGLWDNIVYLDFRSLYPSIIITHNVSP 420
Qy 421 DTLNREGCKEYDVAPEVGHKFCKDFPGFIPSLLGDLLEERQKIKRKMKATVDPLEKKLLD 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 DTLNREGCKEYDVAPEVGHKFCKDFPGFIPSLLGDLLEERQKIKRKMKATVDPLEKKLLD 480
Qy 481 YRQRAIKILANSFYGYYGYAKARWYCKECAESVTAWGREYIEMVIRELEEKFGFKVLYAD 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 YRQRAIKILANSFYGYYGYAKARWYCKECAESVTAWGREYIEMVIRELEEKFGFKVLYAD 540
Qy 541 TDGLHATIPGADAETVKKKAKEFLKYINPKLPGLLELEYEGFYVRGFFVTKKKYAVIDEE 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 TDGLHATIPGADAETVKKKAKEFLKYINPKLPGLLELEYEGFYVRGFFVTKKKYAVIDEE 600
Qy 601 GKITTRGLEIVRRDWSEIAKETQARVLEAILKHGDVEEAVRIVKEVTEKLSKYEVPPEKL 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 GKITTRGLEIVRRDWSEIAKETQARVLEAILKHGDVEEAVRIVKEVTEKLSKYEVPPEKL 660
Qy 661 VIHEQITRDLRDYKATGPHVAVAKRLAARGVKIRPGTVISYIVLKGSGRIGDRAIPADEF 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 VIHEQITRDLRDYKATGPHVAVAKRLAARGVKIRPGTVISYIVLKGSGRIGDRAIPADEF 720
Qy 721 DPTKHRYDAEYYIENQVLPAVERILKAFGYRKEDLRYQKTKQVGLGAWLKVKGKK 775
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 DPTKHRYDAEYYIENQVLPAVERILKAFGYRKEDLRYQKTKQVGLGAWLKVKGKK 775
It would have been prima facie obvious to one having ordinary skill in the art
before the effective filing date of the claimed invention to combine the methods of Tan with those of Sorge since Tan teaches polymerases that may be used in isothermal amplification assays using nickable primers wherein the polymerases may be modified to reduce exonuclease activity, Maples teaches a variety of polymerases that may be used in a nick-based amplification assay, including both
wild-type and variant forms of the DNA polymerase from Thermococcus Sp. strain 9°N,
while Sorge also teaches the amino acid sequence of this same polymerase from
Thermococcus Sp. strain 9°N-7, and further teaches that mutations may be made to
reduce exonuclease activity (column 51, lines 18-22). Thus an ordinary practitioner
would have been motivated to combine the methods of Tan with those of Sorge since one of skill in the art would be able to use the amino acid sequence provided by Sorge as a basis for making mutations in the polymerase that may enhance the utility of the polymerase in amplification assays, such as by reducing exonuclease activity.
Conclusion
No claims are allowed. All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE KANE MUMMERT whose telephone number is (571)272-8503. The examiner can normally be reached M-F 9:00-5:30.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681
Prosecution Insights