Notice of Pre-AIA or AIA Status
1. 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
2. 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.
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3. Claims 2 and 4-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11773433 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017.
The limitations of instant claim 2 are taught in claims 1, 10, 11, 13, 15 and 16 of the issued patent, except for the limitation wherein the biological sample is contacted with a plurality of third probes.
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54).
It would have been obvious to one having ordinary skill in the art to have modified the method of the issued patent to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 4-6, 9, 13, and 15-21 are taught in claims 1, 11-14, 19, 24, 26 and 28 of the issued patent.
Regarding claims 7 and 8, Barany teaches an embodiment wherein the first probe and the second probe hybridize to sequences of the target that are not adjacent to one another and the gap is filled by a polymerase prior to the ligation step (column 45 lines 62-67).
Regarding claim 10, Barany teaches that the probes are ligated by T4 DNA ligase (column 10 line 15).
Regarding claim 11, Barany teaches that the oligonucleotide probes comprise primer-portions (column 10 line 58).
Regarding claim 12, Barany teaches that the ligated probes, primers and a DNA polymerase are used to make extension products (column 4 lines 18-21). The use of a DNA polymerase inherently means that the ligated probes are DNA probes.
Regarding claim 14, Barany teaches that the first DNA probe comprises an SNP1 base at the 3' end for the detection of SNP alleles (column 50, lines 3-7).
4. Claims 2, 3 and 6-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11332790 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017.
The limitations of instant claim 2 are taught in claim 1 of the issued patent, except for the limitation wherein the biological sample is contacted with a plurality of third probes.
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54).
It would have been obvious to one having ordinary skill in the art to have modified the method of the issued patent to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 3, 6-13, and 15-21 are taught in claims 1-3, 7, 9, 10, 14, 18-20, 22, 24, 26 and 28 of the issued patent.
Regarding claim 14, Barany teaches that the first DNA probe comprises an SNP1 base at the 3' end for the detection of SNP alleles (column 50, lines 3-7).
5. Claims 2, 3 and 6-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11505828 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017.
The limitations of instant claim 2 are taught in claims 1, 16 and 30 of the issued patent, except for the limitation wherein the biological sample is contacted with a plurality of third probes.
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54).
It would have been obvious to one having ordinary skill in the art to have modified the method of the issued patent to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 3, 6-13 and 15-21 are taught in claims 1, 4-6, 8, 14, 16, 18-21, 24 and 30 of the issued patent.
Regarding claim 14, Barany teaches that the first DNA probe comprises an SNP1 base at the 3' end for the detection of SNP alleles (column 50, lines 3-7).
6. Claims 2, 3 and 6-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11560593 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017.
The limitations of instant claim 2 are taught in claims 1 and 15 of the issued patent, except for the limitation wherein the biological sample is contacted with a plurality of third probes.
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54).
It would have been obvious to one having ordinary skill in the art to have modified the method of the issued patent to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 3, 6-13, and 15-21 are taught in claims 1. 6-8, 11-13, 16, 18, 19, 21, 22, 24 and 25 of the issued patent.
Regarding claim 14, Barany teaches that the first DNA probe comprises an SNP1 base at the 3' end for the detection of SNP alleles (column 50, lines 3-7).
7. Claims 2 and 4-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11795507 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017.
The limitations of instant claim 2 are taught in claims 1, 4, 12 and 18 of the issued patent, except for the limitation wherein the biological sample is contacted with a plurality of third probes.
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54).
It would have been obvious to one having ordinary skill in the art to have modified the method of the issued patent to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 4-9, 13, and 15-21 are taught in claims 1, 4, 5, 11, 12, 14, 15, 18 and 27 of the issued patent.
Regarding claim 10, Barany teaches that the probes are ligated by T4 DNA ligase (column 10 line 15).
Regarding claim 11, Barany teaches that the oligonucleotide probes comprise primer-portions (column 10 line 58).
Regarding claim 12, Barany teaches that the ligated probes, primers and a DNA polymerase are used to make extension products (column 4 lines 18-21). The use of a DNA polymerase inherently means that the ligated probes are DNA probes.
Regarding claim 14, Barany teaches that the first DNA probe comprises an SNP1 base at the 3' end for the detection of SNP alleles (column 50, lines 3-7).
X. Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11981965 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017).
The limitations of instant claim 2 are taught in claim 1 of the issued patent, except for the limitation wherein the biological sample is contacted with a plurality of third probes.
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54).
It would have been obvious to one having ordinary skill in the art to have modified the method of the issued patent to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 3-5, 7-13 and 15-21 are taught in claims 4, 6, 7, 9-12, 14, 18, 19 and 21-24 of the issued patent.
Regarding claim 6, Barany teaches that the probes hybridize adjacent to one another on the target nucleic acid (claim 1).
Regarding claim 14, Barany teaches that the first DNA probe comprises an SNP1 base at the 3' end for the detection of SNP alleles (column 50, lines 3-7).
8. Claims 2, 3, 6-15, 19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47-67 of copending Application No. 18573162 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017).
The limitations of instant claim 2 are found in claims 47 and 61 of the copending application, except for the limitation wherein the biological sample is contacted with a plurality of third probes.
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54).
It would have been obvious to one having ordinary skill in the art to have modified the method of the copending application to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 3, 6-13, 19 and 21 are taught in claims 47, 50, 52-56 and 59 of the copending application.
Regarding claim 14, Barany teaches that the first DNA probe comprises an SNP1 base at the 3' end for the detection of SNP alleles (column 50, lines 3-7).
Regarding claim 15, Barany teaches that the biological sample is a tissue sample (column 30 line 30).
This is a provisional nonstatutory double patenting rejection.
9. Claims 2, 3, 6-16 18, 19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18233606 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017).
The limitations of instant claim 2 are found in claims 1, 6 and 12 of the copending application, except for the limitation wherein the biological sample is contacted with a plurality of third probes and the limitations of step (g).
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54). Barany additionally teaches that the ligation product is identified by determining its sequencing (column 12 lines 54-65).
It would have been obvious to one having ordinary skill in the art to have modified the method of the copending application to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 4-8, 12, 13, 15, 16, 18 and 19 are taught in claims 1, 6, 8 and 11-14 of the copending application.
Regarding claims 9 and 10, Barany teaches that the probes are ligated by T4 DNA ligase (column 10 line 15).
Regarding claim 11, Barany teaches that the oligonucleotide probes comprise primer-portions (column 10 line 58).
Regarding claim 14, Barany teaches that the first DNA probe comprises an SNP1 base at the 3' end for the detection of SNP alleles (column 50, lines 3-7).
Regarding claim 21, Barany teaches sequencing the ligation product (column 12 lines 54-65).
This is a provisional nonstatutory double patenting rejection.
10. Claims 2 and 4-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-22 of copending Application No. 19023987 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017).
The limitations of instant claim 2 are found in claim 2 of the copending application, except for the limitation wherein the biological sample is contacted with a plurality of third probes.
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54).
It would have been obvious to one having ordinary skill in the art to have modified the method of the copending application to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 4-13 and 15-21 are taught in claims 2-5, 7-10, 16, 17 and 19-22 of the copending application.
Regarding claim 14, Barany teaches that the first DNA probe comprises an SNP1 base at the 3' end for the detection of SNP alleles (column 50, lines 3-7).
This is a provisional nonstatutory double patenting rejection.
11. Claims 2 and 4-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-21 of copending Application No. 19023940 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017).
The limitations of instant claim 2 are found in claim 2 of the copending application, except for the limitation wherein the biological sample is contacted with a plurality of third probes.
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54).
It would have been obvious to one having ordinary skill in the art to have modified the method of the copending application to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 4-21 are taught in claims 2-5, 7-10, 15, 16, and 18-21 of the copending application.
This is a provisional nonstatutory double patenting rejection.
12. Claims 2, 3, 6-15 and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-21 of copending Application No. 18450017 in view of Barany et al (United States Patent No. US9598728, published 21 March 2017).
The limitations of instant claim 2 are found in claim 2 of the copending application, except for the limitation wherein the biological sample is contacted with a plurality of third probes.
However, Barany teaches a template directed ligation method using a first, second and third probe (FIG 1D and column 9 lines 51-54).
It would have been obvious to one having ordinary skill in the art to have modified the method of the copending application to have included a third probe as taught by Barany to arrive at the instantly claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to make this modification because Barany specifically teaches that utilizing three probes allows for the detection of longer target regions with increased specificity (column 10 lines 1-3). In addition, one having ordinary skill in the art would have recognized that the known techniques in the cited references could have been combined with predictable results because the known techniques in the cited references predictably result in the use of oligonucleotide probes for target-specific detection.
The limitations of instant claims 3, 9-13, 15, 19 and 20 are taught in claims 2, 4, 6-8, 11, 17 and 21 of the copending application.
Regarding claim 6, Barany teaches that the probes hybridize adjacent to one another on the target nucleic acid (claim 1).
Regarding claims 7 and 8, Barany teaches an embodiment wherein the first probe and the second probe hybridize to sequences of the target that are not adjacent to one another and the gap is filled by a polymerase prior to the ligation step (column 45 lines 62-67).
Regarding claim 14, Barany teaches that the first DNA probe comprises an SNP1 base at the 3' end for the detection of SNP alleles (column 50, lines 3-7).
Regarding claim 21, Barany teaches sequencing the ligation product (column 12 lines 54-65).
This is a provisional nonstatutory double patenting rejection.
Conclusion
13. No claims are allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN ELLIS YOUNG whose telephone number is (703)756-5397. The examiner can normally be reached M-T 0800 - 1630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN ELLIS YOUNG/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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