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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claims 61-69, 71-80, and 84 are objected to because of the following informalities (informalities identified by proposed amendments to resolve respective informalities):
Claim 61. A method for determining a relative dilution of a biological test sample from a subject, the method for determining the relative dilution comprising:
generating a composite dilution model for at least one analyte from the biological test sample by:
a) determining [[the]]a level of [[an]]the at least one analyte in a first dilution series of a first biological sample comprising the analyte, wherein the first dilution series comprises at least three (3) different dilutions, and the level of the analyte is determined in each of the at least three different dilutions;
b) determining a level of the analyte in a second dilution series of a second biological sample comprising the analyte, wherein the second dilution series comprises at least three (3) different dilutions, and the level of the analyte is determined in each of the at least three different dilutions of the second dilution series;
c) generating a second model based on the level in the analyte of the first dilution series;
d) selecting a reference value, wherein the reference value is selected from:
(i) a second dilution series reference value that is an analyte level at a specific dilution of the second dilution series;
(ii) a model reference value that is an analyte level at a specific dilution of the second model; and
(iii) an arbitrary reference value that is an analyte level at a second specific dilution, wherein the analyte level at [[that]]the second specific dilution is not found in the second dilution series or the second model;
e) performing at least one horizontal translation, wherein the at least one horizontal translation is selected from:
(i) a horizontal translation of the second dilution series reference value to a model value, wherein the model value is an analyte level at a third specific dilution of the second model, wherein the second dilution series reference value and the model value are equivalent or substantially equivalent;
(ii) a horizontal translation of the model reference value to a second dilution series second value, wherein the second dilution series second value is [[an]]the analyte level at [[a]]the specific dilution of the second dilution series, wherein the model reference value and the second dilution series second value are equivalent or substantially equivalent; and
(iii) horizontal translations of a second dilution series third value and a second model value to the arbitrary reference value, wherein the second model value is [[an]]the analyte level at [[a]]the specific dilution of the second model, wherein the second dilution series third value is [[an]]the analyte level at [[a]]the specific dilution of the second dilution series, and wherein the second dilution series third value, the second model value and the arbitrary reference value are equivalent or substantially equivalent;
f) performing the at least one horizontal translation of second model, or (iii) the second dilution series and the second model, wherein the horizontal translations of the remaining values results in a lined composite translation; and
g) fitting a function to the lined composite translation thereby forming [[a]]the composite dilution model; and
horizontally translating a level of the at least one analyte from the biological test sample to the composite dilution model generated for the at least one analyte, thereby determining the relative dilution of the biological test sample from the subject based on the horizontal translation.
Claim 62. The method of claim 61, wherein the method comprises:
d) selecting [[a]]the second dilution series reference value that is [[an]]the analyte level at [[a]]the specific dilution of the second dilution series;
e) performing [[a]]the horizontal translation of the second dilution series reference value to [[a]]the model value, wherein the model value is [[an]]the analyte level at [[a]]the third specific dilution of the second model, wherein the second dilution series reference value and the model value are equivalent or substantially equivalent; and
f) performing the horizontal translation of the remaining values in the second dilution series, wherein the horizontal translation of the remaining values results in [[a]]the lined composite translation.
Claim 63. The method of claim 61, wherein the method comprises:
d) selecting [[a]]the model reference value that is [[an]]the analyte level at [[a]]the specific dilution of the second model;
e) performing [[a]]the horizontal translation of the model reference value to [[a]]the second dilution series second value, wherein the second dilution series second value is [[an]]the analyte level at [[a]]the specific dilution of the second dilution series, wherein the model reference value and the second dilution series second value are equivalent or substantially equivalent; and
f) performing the horizontal translation of the remaining values in the second model, wherein the horizontal translation of the remaining values results in [[a]]the lined composite translation.
Claim 64. The method of claim 61, wherein the method comprises:
d) selecting [[an]]the arbitrary reference value that is [[an]]the analyte level at [[a]]the second specific dilution, wherein the analyte level at [[that]]the second specific dilution is not found in the second dilution series or the second model;
e) performing [[a]]the horizontal translation of [[a]]the second dilution series third value and [[a]]the second model value to the arbitrary reference value, wherein the second model value is [[an]]the analyte level at [[a]]the specific dilution of the second model, wherein the second dilution series third value is [[an]]the analyte level at [[a]]the specific dilution of the second dilution series, and wherein the second dilution series third value, the second model value and the arbitrary reference value are equivalent or substantially equivalent; and
f) performing the horizontal translations of the remaining values in the second dilution series and the second model, wherein the horizontal translations of the remaining values results in [[a]]the lined composite translation.
Claim 65. A method for determining a relative dilution of a biological test sample from a subject, the method for determining the relative dilution comprising:
generating a composite dilution model for at least one analyte from the biological test sample by:
a) determining [[the]]a level of [[an]]the at least one analyte in a first dilution series of a first biological sample comprising the analyte, wherein the first dilution series comprises at least three (3) different dilutions, and the level of the analyte is determined in each of the at least three different dilutions;
b) determining a level of the analyte in a second dilution series of a second biological sample comprising the analyte, wherein the second dilution series comprises at least three (3) different dilutions, and the level of the analyte is determined in each of the at least three different dilutions of the second dilution series;
c) generating a second model based on the level in the analyte of the first dilution series;
d) performing at least one horizontal translation, wherein the at least one horizontal translation is selected from:
(i) a horizontal translation of the second dilution series to the second model;
(ii) a horizontal translation of the second model to the second dilution series; and
(iii) horizontal translations of the second dilution series and the second model to an arbitrary reference value, wherein the arbitrary reference value is an analyte level at a second specific dilution, wherein the analyte level at [[that]]the second specific dilution is not found in the second dilution series or the second model, wherein the at least one horizontal translation results in a lined composite translation; and
e) fitting a function to the lined composite translation thereby forming [[a]]the composite dilution model; and
horizontally translating a level of the at least one analyte from the biological test sample to the composite dilution model generated for the at least one analyte, thereby determining the relative dilution of the biological test sample from the subject based on the horizontal translation.
Claim 66. The method of claim 65, wherein the method comprises performing [[a]]the horizontal translation of the second dilution series to the second model.
Claim 67. The method of claim 65, wherein the method comprises performing [[a]]the horizontal translation of the second model to the second dilution series.
Claim 68. The method of claim 65, wherein the method comprises performing [[a]]the horizontal translation of the second dilution series and the second model to [[an]]the arbitrary reference value that is [[an]]the analyte level at [[a]]the second specific dilution, wherein the analyte level at [[that]]the second specific dilution is not found in the second dilution series or the second model.
Claim 69. A method for determining a relative dilution of a biological test sample from a subject, the method for determining the relative dilution comprising:
generating a composite dilution model for at least one analyte from the biological test sample by:
a) determining [[the]]a level of [[an]]the at least one analyte in a first dilution series of a first biological sample comprising the analyte, wherein the first dilution series comprises at least three (3) different dilutions, and the level of the analyte is determined in each of the at least three different dilutions;
b) determining a level of the analyte in a second dilution series of a second biological sample comprising the analyte, wherein the second dilution series comprises at least three (3) different dilutions, and the level of the analyte is determined in each of the at least three different dilutions of the second dilution series;
c) selecting a reference value, wherein the reference value is selected from:
(i) a second dilution series reference value that is an analyte level at a specific dilution of the second dilution series; and
(ii) an arbitrary reference value that is an analyte level at a specific dilution, wherein the analyte level at [[that]]the specific dilution is not found in the first dilution series or the second dilution series;
d) performing at least one horizontal translation, wherein the at least one horizontal translation is selected from:
(i) a horizontal translation of the second dilution series reference value to a first dilution series value, wherein the first dilution series value is an analyte level at a specific dilution of the first dilution series, wherein the second dilution series reference value and the first dilution series value are equivalent or substantially equivalent; and
(ii) horizontal translations of the first dilution series and the second dilution series to the arbitrary reference value; wherein the at least one horizontal translation results in a lined composite translation; and
e) fitting a function to the lined composite translation thereby forming [[a]]the composite dilution model; and
horizontally translating a level of the at least one analyte from the biological test sample to the composite dilution model generated for the at least one analyte, thereby determining the relative dilution of the biological test sample from the subject based on the horizontal translation.
Claim 71. The method of claim 69, wherein the method comprises the horizontal translations of the first dilution series and the second dilution series to [[an]]the arbitrary reference value, wherein the arbitrary reference value is [[an]]the analyte level at [[a]]the specific dilution, wherein the analyte level at [[that]]the specific dilution is not found in the first dilution series or the second dilution series.
Claim 72. The method of claim 61, wherein [[the]]a level of the analyte is determined in each of at least 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or 16 different dilutions in the first dilution series or in the second dilution series.
Claim 73. The method of claim 61, wherein each model of the second model and the composite dilution model is independently selected from a linear regression model, a LOESS curve fitting model, a non-linear regression model, a spline fit model, a mixed effects regression model, a fixed effects regression model, a generalized linear model, a matrix decomposition model, and a four parameter logistic regression (4PL) model.
Claim 74. The method of claim 61, wherein the level of the analyte in the first dilution series and the level of the analyte in the second dilution series are each a respective analyte or a concentration of the respective analyte.
Claim 75. The method of claims 61, wherein [[a]]the selected reference value is within a linear range of the first dilution series, within a linear range of the second dilution series, a linear range of the first model, or within a linear range of the second model.
Claim 76. The method of claim 61, wherein the first biological sample and the second biological sample each comprise urine.
Claim 77. The method of claim 61, wherein the first biological sample and the second biological sample are each collected from the
Claim 78. The method of any one of claims 61, wherein the first biological sample and the second biological sample are
Claim 79. The method of claim 61, wherein the level of the analyte [[is]]in the first dilution series and the level of the analyte in the second dilution series are each measured by an assay that uses an aptamer, antibody, mass spectrophotometer or a combination thereof.
Claim 80. The method of claim 61, wherein a dilution factor for each of the first dilution series and the second dilution series is a constant dilution factor.
Claim 84. The method of claim 61, wherein the biological test sample, the first biological sample, and the second biological sample used to develop the composite dilution model are [[the]]a same sample type.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 83 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 83 recites the limitation “wherein the method further comprises horizontally translating the level of at least one analyte from a biological test sample to the composite dilution model for the at least one analyte, thereby determining the relative dilution of the biological test sample” all of which is required in claim 61 from which claim 83 depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Likuski et al. (U.S. 2010/0049444) is considered the closest prior art.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 61-82 and 84 would be allowed primarily because the prior art of record cannot anticipate Applicant’s claimed invention by a single reference nor render Applicant’s claimed invention obvious by the combination of more than one reference.
Additionally, the prior art of record does not teach a method for determining a relative dilution of a biological test sample from a subject with the claimed steps in claims 61-82 and 84.
Therefore, the prior art of record cannot anticipate Applicant’s claimed invention by a single reference nor render Applicant’s claimed invention obvious by one or more references.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhang et al. (U.S. 2012/0142554) and Likuski et al. (U.S. 2010/0049444).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Loren C Edwards whose telephone number is (571)272-7133. The examiner can normally be reached M-R 6AM-430PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Laurenzi can be reached at (571) 270-7878. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOREN C EDWARDS/Primary Examiner, Art Unit 3746 6/5/26
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