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 .
Status of the claims
The Preliminary Amendment filed 05/27/25 is acknowledged and has been entered. Claims 1-20 have been canceled. New claims 21-39 have been added. Accordingly, claims 21-39 are under examination.
Specification
The disclosure is objected to because of the following informalities: The specification on page 1 should indicate the current status of all nonprovisional parent application references. For example, after the disclosure “U.S. Patent Application No. 18/315,230, filed May 10, 2023”. Applicant should insert --, now U.S. Patent 12,298,315--.
Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 21-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,298,315 in view of Blankenberg et al (US 20060105419). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and US 12,298,315 are directed to a method comprising obtaining a sample from a human female subject; assaying the MoM concentration of PIGF and sVEGFR-2; assessing a ratio of PIGF/sVEGFR-1; comparing the ratio to a threshold; identifying the presence or risk of imbalance of antigogenic factors and treating obstetrical complication with a statin based on a ratio below the threshold. U.S. 12,298,315 fails to teach the MoM concentration threshold is <0.326 for PIGF/sVEGFR-1. However, it was recognized in the prior art that the sensitivity and specificity is a measure of the accuracy of a test, reflecting the number (if any) of false positives and false negatives. Furthermore, sensitivity and specificity may be adjusted by adjusting the value of a threshold or cutoff value, above which (or below which, depending on how a marker changes with the disease) the test is considered to be indicative of one state or condition (e.g., diseased) and below which the test is considered to be indicative of another state or condition (e.g., non-diseased). See Blankenberg et al at [0007], [0028], [0084]. Accuracy need not be 100%; however Blankenberg et al indicates that particularly preferred would be where both the sensitivity and specificity are at least about 75%, more preferably at least about 80%, even more preferably at least about 85%, still more preferably at least about 90%, and most preferably at least about 95% [0028].
The teachings of Blankenberg et al indicate that the sensitivity and selectivity of a diagnostic test was known to be a result-effective variable, impacting the number of individuals who are correctly diagnosed with disease. Furthermore, the teachings of Blankenberg et al indicate that it was known in the prior art to optimize tests for desired levels of sensitivity and specificity, by selecting appropriate threshold or cutoff values. Finally, Blankenberg et al clearly expresses that tests where both the sensitivity and specificity are at least about 80% would be viewed as particularly preferred.
Therefore, it would have been obvious to one of ordinary skill in the art at the to incorporate comparison to a control and to arrive at the claimed invention by optimizing threshold levels in order to achieve a desired sensitivity and specificity as claimed, given that such percentages were recognized in the art to be particularly preferred for diagnostic tests. One skilled in the art would have been motivated to select such ratios of sensitivity and specificity out of the course of routine optimization, given that these measures of test accuracy were recognized in the prior art to be result-effective variables that impact the number of false negatives and false positives for the test. Finally, one skilled in the art would have had a reasonable expectation of success in arriving at the claimed sensitivity and specificity since means of achieving desired sensitivity and specificity were known, namely by selecting an appropriate threshold or cutoff level (as taught by Blankenberg et al).
Claims 21-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,686,735 in view of Blankenberg et al (US 20060105419). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and US 11,686,735 are directed to a method comprising obtaining a sample from a human female subject; assaying the MoM concentration of PIGF and sVEGFR-2; assessing a ratio of PIGF/sVEGFR-1; comparing the ratio to a threshold; identifying the presence or risk of imbalance of antigogenic factors and treating obstetrical complication with a statin based on a ratio below the threshold. U.S. 11,686,735 fails to teach the MoM concentration threshold is <0.326 for PIGF/sVEGFR-1. However, it was recognized in the prior art that the sensitivity and specificity is a measure of the accuracy of a test, reflecting the number (if any) of false positives and false negatives. Furthermore, sensitivity and specificity may be adjusted by adjusting the value of a threshold or cutoff value, above which (or below which, depending on how a marker changes with the disease) the test is considered to be indicative of one state or condition (e.g., diseased) and below which the test is considered to be indicative of another state or condition (e.g., non-diseased). See Blankenberg et al at [0007], [0028], [0084]. Accuracy need not be 100%; however Blankenberg et al indicates that particularly preferred would be where both the sensitivity and specificity are at least about 75%, more preferably at least about 80%, even more preferably at least about 85%, still more preferably at least about 90%, and most preferably at least about 95% [0028].
The teachings of Blankenberg et al indicate that the sensitivity and selectivity of a diagnostic test was known to be a result-effective variable, impacting the number of individuals who are correctly diagnosed with disease. Furthermore, the teachings of Blankenberg et al indicate that it was known in the prior art to optimize tests for desired levels of sensitivity and specificity, by selecting appropriate threshold or cutoff values. Finally, Blankenberg et al clearly expresses that tests where both the sensitivity and specificity are at least about 80% would be viewed as particularly preferred.
Therefore, it would have been obvious to one of ordinary skill in the art at the to incorporate comparison to a control and to arrive at the claimed invention by optimizing threshold levels in order to achieve a desired sensitivity and specificity as claimed, given that such percentages were recognized in the art to be particularly preferred for diagnostic tests. One skilled in the art would have been motivated to select such ratios of sensitivity and specificity out of the course of routine optimization, given that these measures of test accuracy were recognized in the prior art to be result-effective variables that impact the number of false negatives and false positives for the test. Finally, one skilled in the art would have had a reasonable expectation of success in arriving at the claimed sensitivity and specificity since means of achieving desired sensitivity and specificity were known, namely by selecting an appropriate threshold or cutoff level (as taught by Blankenberg et al).
Claims 21-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,281, 475 in view of Blankenberg et al (US 20060105419). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and US 10,281,475 are directed to a method comprising obtaining a sample from a human female subject; assaying the MoM concentration of PIGF and sVEGFR-2; assessing a ratio of PIGF/sVEGFR-1; comparing the ratio to a threshold; identifying the presence or risk of imbalance of antigogenic factors and treating obstetrical complication with a statin based on a ratio below the threshold. U.S. 10,281,475 fails to teach the MoM concentration threshold is <0.326 for PIGF/sVEGFR-1. However, it was recognized in the prior art that the sensitivity and specificity is a measure of the accuracy of a test, reflecting the number (if any) of false positives and false negatives. Furthermore, sensitivity and specificity may be adjusted by adjusting the value of a threshold or cutoff value, above which (or below which, depending on how a marker changes with the disease) the test is considered to be indicative of one state or condition (e.g., diseased) and below which the test is considered to be indicative of another state or condition (e.g., non-diseased). See Blankenberg et al at [0007], [0028], [0084]. Accuracy need not be 100%; however Blankenberg et al indicates that particularly preferred would be where both the sensitivity and specificity are at least about 75%, more preferably at least about 80%, even more preferably at least about 85%, still more preferably at least about 90%, and most preferably at least about 95% [0028].
The teachings of Blankenberg et al indicate that the sensitivity and selectivity of a diagnostic test was known to be a result-effective variable, impacting the number of individuals who are correctly diagnosed with disease. Furthermore, the teachings of Blankenberg et al indicate that it was known in the prior art to optimize tests for desired levels of sensitivity and specificity, by selecting appropriate threshold or cutoff values. Finally, Blankenberg et al clearly expresses that tests where both the sensitivity and specificity are at least about 80% would be viewed as particularly preferred.
Therefore, it would have been obvious to one of ordinary skill in the art at the to incorporate comparison to a control and to arrive at the claimed invention by optimizing threshold levels in order to achieve a desired sensitivity and specificity as claimed, given that such percentages were recognized in the art to be particularly preferred for diagnostic tests. One skilled in the art would have been motivated to select such ratios of sensitivity and specificity out of the course of routine optimization, given that these measures of test accuracy were recognized in the prior art to be result-effective variables that impact the number of false negatives and false positives for the test. Finally, one skilled in the art would have had a reasonable expectation of success in arriving at the claimed sensitivity and specificity since means of achieving desired sensitivity and specificity were known, namely by selecting an appropriate threshold or cutoff level (as taught by Blankenberg et al).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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