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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 9/6/2026.
Claims 1-14 and 18-23 are pending.
Claims 1-14 and 18-23 are under examination in this Office Action.
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.
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Claims 1-14 and 18-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent Number 10640809.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claim 1 is drawn to a method of analyzing rare nucleic acid species comprising: (a) providing a library of double-stranded nucleic acids, wherein the library of double-stranded nucleic acids comprises complementary DNA (cDNA) prepared from RNA; (b) denaturing the library; (c) renaturing the library under conditions sufficient to renature abundant nucleic acid species, wherein a portion of the library comprising less abundant nucleic acid species does not renature; (d) contacting the library with a nucleic acid binding protein that preferentially binds to double-stranded nucleic acids; and (e) separating renatured abundant nucleic acid species from the less abundant nucleic acid species and claim 1 in U.S. Patent Number 10640809 is drawn to a method of analyzing rare nucleic acid species comprising: (a) providing a library of double-stranded nucleic acids; (b) denaturing the library; (c) renaturing the library under conditions sufficient to renature abundant nucleic acid species, wherein a portion of the library comprising less abundant nucleic acid species does not renature; (d) contacting the library with a transposase that preferentially binds to double-stranded nucleic acids; and (e) separating renatured abundant nucleic acid species from the less abundant nucleic acid species.
Therefore, the present claims are obvious in view of the claims of U.S. Patent Number 10640809.
Claims 1-14 and 18-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of U.S. Patent Number 11339422.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claim 1 is drawn to a method of analyzing rare nucleic acid species comprising: (a) providing a library of double-stranded nucleic acids, wherein the library of double-stranded nucleic acids comprises complementary DNA (cDNA) prepared from RNA; (b) denaturing the library; (c) renaturing the library under conditions sufficient to renature abundant nucleic acid species, wherein a portion of the library comprising less abundant nucleic acid species does not renature; (d) contacting the library with a nucleic acid binding protein that preferentially binds to double-stranded nucleic acids; and (e) separating renatured abundant nucleic acid species from the less abundant nucleic acid species and claim 1 in U.S. Patent Number 11339422 is drawn to a method of analyzing rare nucleic acid species comprising: (a) providing a library of double-stranded nucleic acids; (b) denaturing the library; (c) renaturing the library under conditions sufficient to renature abundant nucleic acid species, wherein a portion of the library comprising less abundant nucleic acid species does not renature; (d) contacting the library with a nucleic acid binding protein that preferentially binds to double-stranded nucleic acids, wherein the nucleic acid binding protein does not comprise double stranded DNA nuclease activity; and (e) separating renatured abundant nucleic acid species from the less abundant nucleic acid species, wherein separating comprises immobilizing the binding protein to a solid support.
Therefore, the present claims are obvious in view of the claims of U.S. Patent Number 11339422.
Claims 1-14 and 18-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22 of U.S. Patent Number 11795578.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claim 1 is drawn to a method of analyzing rare nucleic acid species comprising: (a) providing a library of double-stranded nucleic acids, wherein the library of double-stranded nucleic acids comprises complementary DNA (cDNA) prepared from RNA; (b) denaturing the library; (c) renaturing the library under conditions sufficient to renature abundant nucleic acid species, wherein a portion of the library comprising less abundant nucleic acid species does not renature; (d) contacting the library with a nucleic acid binding protein that preferentially binds to double-stranded nucleic acids; and (e) separating renatured abundant nucleic acid species from the less abundant nucleic acid species and claim 1 in U.S. Patent Number 11795578 is drawn to a method of analyzing rare nucleic acid species comprising: (a) providing a library of double-stranded nucleic acids; (b) denaturing the library; (c) renaturing the library under conditions sufficient to renature abundant nucleic acid species, wherein a portion of the library comprising less abundant nucleic acid species does not renature; (d) contacting the library with a nucleic acid binding protein that preferentially binds to single-stranded nucleic acids; and (e) separating renatured abundant nucleic acid species from the less abundant nucleic acid species.
Therefore, the present claims are obvious in view of the claims of U.S. Patent Number 11795578.
Closest Prior Art
The following is the closest prior art:
Dorange et al. (10/22/2015) PCT International Patent Application Publication WO 2015/160895 A2 cited in the 9/6/2023 IDS (hereinafter referred to as "Dorange") represents the closest prior art. Dorange teaches a method for the detection of rare target nucleic acids by extracting nucleic acids from a sample, denaturing and renaturing and treating with duplex specific nuclease and nucleic acid sequencing (see claim 1 and pages 3 to 30). Dorange does not explicitly teach a method of analyzing rare nucleic acid species comprising: (a) providing a library of double-stranded nucleic acids, wherein the library of double-stranded nucleic acids comprises complementary DNA (cDNA) prepared from RNA; (b) denaturing the library; (c) renaturing the library under conditions sufficient to renature abundant nucleic acid species, wherein a portion of the library comprising less abundant nucleic acid species does not renature; (d) contacting the library with a nucleic acid binding protein that preferentially binds to double-stranded nucleic acids; and (e) separating renatured abundant nucleic acid species from the less abundant nucleic acid species.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
Prosecution Insights