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
Status of the Claims
Claims 23-40 are pending and the subject of this FINAL Office Action.
This is a CON of applicant's earlier Application No. 17/692,265. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Double Patenting- Obvious Type
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Instant claims 23-40 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over conflicting claims 1-20 of US 10648025, in view of US20180216163, US 20170022571, US 20140341841 and US 20160350477.
The conflicting method claims teach the same method without explicitly teaching MOPS buffer or endogenous plus spike-in controls. However, the conflicting claims state “a buffer comprising Mg++” and “said buffer comprising Mg++ comprises between about 6 to 10 mM Mg++.” Looking to the specification to find which species of “buffer,” the specification states (emphasis added)
While the method is not limited to a particular concentration of Mg++ in the buffer used in said first reaction mixture and in the PCR-flap assay reaction mixture, in preferred embodiments, the buffer comprises at least 3 mM Mg++, preferably greater than 4 mM Mg++, more preferably greater than 5 mM Mg++, more preferably greater than 6 mM Mg++, more preferably between approximately 7 mM and 7.5 mM Mg++. In certain embodiments, the buffer contains less than about 1 mM KCl. In preferred embodiments, the buffer comprises 10 mM 3-(n-morpholino) propanesulfonic acid (MOPS) buffer and 7.5 mM MgCl2.
Thus, the conflicting claims, as interpreted by the specification, teach the claimed MOPS and magnesium buffer.
As to endogenous plus spike-in controls, these are routinely applied in the art to control for process (nucleic acid extraction, amplification, etc.) variance, and amplification variance. For example, US20170022571 recognizes these commonly-understood facts by utilizing both endogenous GAPDH plus spike-in controls (paras. 0225-30 & 0247). As do US 20160350477 (spike-in plus endogenous control is a routine practice; paras. 0042-44); US20140341841 (paras. 0012, 0021, 0026, 0105, 0109, 0112, 0113, 0120, 0125, Table 1); and US20180216163 (“samples A-D represent a complex mixture of synthetic (ERCC controls) and endogenous RNA targets in known proportions that can be used as ground truth benchmarks for assessing a method's analytical performance characteristics across a greater than 106 fold dynamic range of abundances,” para. 0155; see also paras. 0154-55, 0159-70, 0183-95, 0247-48). Thus, the use of endogenous plus spike-in controls is so routine and well-known in nucleic acid amplification assays that it constitutes a familiar application to other familiar amplification schemes with expected familiar results.
Instant claims 23-40 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over conflicting claims 1-7 of US 10704081, in view of US20180216163, US 20170022571, US 20140341841 and US 20160350477.
The conflicting method claims teach the same method without explicitly teaching MOPS buffer or endogenous plus spike-in controls. However, the conflicting claims state “buffer comprises 6 to 10 mM MgCl2.” Looking to the specification to find which species of “buffer,” the specification states (emphasis added)
While the method is not limited to a particular concentration of Mg++ in the buffer used in said first reaction mixture and in the PCR-flap assay reaction mixture, in preferred embodiments, the buffer comprises at least 3 mM Mg++, preferably greater than 4 mM Mg++, more preferably greater than 5 mM Mg++, more preferably greater than 6 mM Mg++, more preferably between approximately 7 mM and 7.5 mM Mg++. In certain embodiments, the buffer contains less than about 1 mM KCl. In preferred embodiments, the buffer comprises 10 mM 3-(n-morpholino) propanesulfonic acid (MOPS) buffer and 7.5 mM MgCl2.
Thus, the conflicting claims, as interpreted by the specification, teach the claimed MOPS and magnesium buffer.
As to endogenous plus spike-in controls, these are routinely applied in the art to control for process (nucleic acid extraction, amplification, etc.) variance, and amplification variance. For example, US20170022571 recognizes these commonly-understood facts by utilizing both endogenous GAPDH plus spike-in controls (paras. 0225-30 & 0247). As do US 20160350477 (spike-in plus endogenous control is a routine practice; paras. 0042-44); US20140341841 (paras. 0012, 0021, 0026, 0105, 0109, 0112, 0113, 0120, 0125, Table 1); and US20180216163 (“samples A-D represent a complex mixture of synthetic (ERCC controls) and endogenous RNA targets in known proportions that can be used as ground truth benchmarks for assessing a method's analytical performance characteristics across a greater than 106 fold dynamic range of abundances,” para. 0155; see also paras. 0154-55, 0159-70, 0183-95, 0247-48). Thus, the use of endogenous plus spike-in controls is so routine and well-known in nucleic acid amplification assays that it constitutes a familiar application to other familiar amplification schemes with expected familiar results.
Instant claims 23-40 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over conflicting claims 1-7 of US 11299766.
The conflicting method claims teach the same method using both reference control and process control (claims 18 and 20) without explicitly teaching MOPS buffer. However, the conflicting claims state “buffer comprises 6 to 10 mM MgCl2.” Looking to the specification to find which species of “buffer,” the specification states (emphasis added)
While the method is not limited to a particular concentration of Mg++ in the buffer used in said first reaction mixture and in the PCR-flap assay reaction mixture, in preferred embodiments, the buffer comprises at least 3 mM Mg++, preferably greater than 4 mM Mg++, more preferably greater than 5 mM Mg++, more preferably greater than 6 mM Mg++, more preferably between approximately 7 mM and 7.5 mM Mg++. In certain embodiments, the buffer contains less than about 1 mM KCl. In preferred embodiments, the buffer comprises 10 mM 3-(n-morpholino) propanesulfonic acid (MOPS) buffer and 7.5 mM MgCl2.
Thus, the conflicting claims, as interpreted by the specification, teach the claimed MOPS and magnesium buffer.
Instant claims 23-40 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over conflicting claims 1-7 of US 10385406, in view of US20180216163, US 20170022571, US 20140341841 and US 20160350477.
The conflicting method claims teach the same method using reference marker and without explicitly teaching MOPS buffer or endogenous plus spike-in controls. However, the conflicting claims state “buffer comprising Mg++.” Looking to the specification to find which species of “buffer,” the specification discloses a single such buffer (emphasis added)
A pre-amplification is conducted, for example, in a reaction mixture containing 7.5 mM MgCl2, 10 mM MOPS, 0.3 mM Tris-HC1, pH 8.0, 0.8 mM KC1, 0.1 μg/μL BSA, 0.0001% Tween-20, 0.0001% IGEPAL CA-630, 250 μM each dNTP, oligonucleotide primers, (e.g., for 12 targets, 12 primer pairs/24 primers, in equimolar amounts (including but not limited to the ranges of, e.g., 200-500 nM each primer), or with individual primer concentrations adjusted to balance amplification efficiencies of the different target regions), 0.025 units/μL HotStart GoTaq concentration, and 20 to 50% by volume of bisulfate-treated target DNA (e.g., 10 μL of target DNA into a 50 μL reaction mixture, or 50 μL of target DNA into a 125 μL reaction mixture)..
Thus, the conflicting claims, as interpreted by the specification, teach the claimed MOPS and magnesium buffer.
As to endogenous plus spike-in controls, these are routinely applied in the art to control for process (nucleic acid extraction, amplification, etc.) variance, and amplification variance. For example, US20170022571 recognizes these commonly-understood facts by utilizing both endogenous GAPDH plus spike-in controls (paras. 0225-30 & 0247). As do US 20160350477 (spike-in plus endogenous control is a routine practice; paras. 0042-44); US20140341841 (paras. 0012, 0021, 0026, 0105, 0109, 0112, 0113, 0120, 0125, Table 1); and US20180216163 (“samples A-D represent a complex mixture of synthetic (ERCC controls) and endogenous RNA targets in known proportions that can be used as ground truth benchmarks for assessing a method's analytical performance characteristics across a greater than 106 fold dynamic range of abundances,” para. 0155; see also paras. 0154-55, 0159-70, 0183-95, 0247-48). Thus, the use of endogenous plus spike-in controls is so routine and well-known in nucleic acid amplification assays that it constitutes a familiar application to other familiar amplification schemes with expected familiar results.
Previous Response to Arguments
The rejection is maintained because “the disclosure may be used to learn the meaning of terms and in “‘interpreting the coverage of [a] claim.’” See In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371, 1378 (Fed. Cir. 2008) (quoting In re Vogel, 422 F.2d 438, 441 (CCPA 1970); see also In re Hitachi Metals, Ltd., 603 F. App'x 976, 979 (Fed. Cir. 2015) (“However, this does not mean that the court must close its eyes to the specification entirely. For example, the court may look to the specification to define terms found in the claims.”). The Examiner explained that in order to learn the meaning of “a buffer comprising Mg++” in the conflicting claims, the Examiner looked to the specification of the conflicting claims. A skilled artisan would be required to do this in order to interpret the coverage of the conflicting claims that recite “a buffer comprising Mg++.” The conflicting claims are directed to, in part, a specific “reaction mixture with PCR amplification reagents” which includes “a buffer comprising Mg++” to achieve a specific “PCR-flap assay reaction.” A skilled artisan would be required to look to the specification to determine what “buffer comprising Mg++” can be used in this claimed context. The specification discloses a single “buffer comprising Mg++” that meets this requirement:
A pre-amplification is conducted, for example, in a reaction mixture containing 7.5 mM MgCl2, 10 mM MOPS, 0.3 mM Tris-HC1, pH 8.0, 0.8 mM KC1, 0.1 μg/μL BSA, 0.0001% Tween-20, 0.0001% IGEPAL CA-630, 250 μM each dNTP, oligonucleotide primers, (e.g., for 12 targets, 12 primer pairs/24 primers, in equimolar amounts (including but not limited to the ranges of, e.g., 200-500 nM each primer), or with individual primer concentrations adjusted to balance amplification efficiencies of the different target regions), 0.025 units/μL HotStart GoTaq concentration, and 20 to 50% by volume of bisulfate-treated target DNA (e.g., 10 μL of target DNA into a 50 μL reaction mixture, or 50 μL of target DNA into a 125 μL reaction mixture)..
Thus, the conflicting claims, as interpreted by the specification, teach the claimed MOPS and magnesium buffer.
Conclusion
No claims are allowed.
This is a CON of applicant's earlier Application No. 17/692,265. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aaron Priest whose telephone number is (571)270-1095. The examiner can normally be reached 8am-6pm.
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.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681
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