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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Priority
This application is a CON of PCT/EP2019/069257 (07/17/2019) which is also a CON of 16/039,376 (07/19/2018 ABN).
Claim Status
Claims 1-2, 4-7, 10, 13, 15-21 and 23-24 are previously presented. Claims 3 is original. Claims 8-9, 11-12, 14 and 22 are cancelled. Claims 25-26 are new and the Applicant notes that no new matter is added.
Thus, claims 1-7, 10, 13, 15-21 and 23-26 are pending and are under examination.
Maintained Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 3 and 16 are directed to obtaining the combined value v by weighted calculation of the combined value using an equation (i.e., wherein the combined value v is obtained by weighted calculation … according to the equation: v =a* [Aβ40] + b * [Aβ42] + c * [tTau] + d]). However, the equation requires the values for a, b, c and d which are not taught nor described by the specification.
The values for a, b, c and d are not defined the claims nor in the specification. The specification only recites that a, b, c and d are weighting factor that are calculated using an equation (Page 24, lines 14-18). The specification further shows some exemplary values for a, b, c and d in Table 1b of Example 4 without describing how the values were obtained (Page 25, Table 1b). Although there is a recitation for a, b, c and d in the specification, it does not explain what are the values for a, b, c and d and how they are determined in a way to provide written support for how to use the equation to obtain the combined value as claimed. As such, the written description is lacking in regards to a, b, c and d and it is not clear how to obtain their values.
While the prior art provides methods on how to detect Aβ40, Aβ42 and tTau protein markers from biological fluids (Frölich et al., Kasai et al. and Mattsson et al.), these markers are not at all provided in one equation with the values for a, b, c and d. The values for a, b, c and d are not described in the prior art in a way that a skilled artisan would have recognized that the inventor of the instant application was in possession of the invention as claimed in view of the disclosure of the instant application as filed.
The Applicant has not pointed out where the claim is supported, nor does there appear to be a written description of the claim limitation ‘a, b, c, and d’ in the application as filed.
Thus, based on the disclosure and the state of the art, the Applicant does not have possession of claims 3 and 16.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3 and 16 are claiming that the weighted calculation of the combined value is obtained by an equation [i.e., wherein the combined value (v) is obtained by weighted calculation … according to the equation: v =a* [Aβ40] + b * [Aβ42] + c * [tTau] + d]. However, the equation requires the values for a, b, c and d which are not taught as described. Because the values of a, b, c and d are not taught by the specification, the equation for obtaining the combined value (v) by weighted calculation cannot be performed. Thus, it is not clear how to obtain the combined value (v) from the above equation by weighted calculation which makes claims 3 and 16 vague and indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
This rejection also applies to newly added claim 25 as was necessitated by the amendments introduced through the addition of new claims.
Claims 1-7, 10, 13, 15-21 and 23-25 are rejected under 35 U.S.C. 101 because the claimed invention is for a process or a method that is directed to at least one judicial exception without significantly more. The claims recite a mere collection of information in the form of data that is compared to control data from which the applicant or doctor will be able to determine the diagnosis of a patient or assess the risk of having an amyloid-positive dementia. Such an inference is not sufficient to transform the abstract idea of a mathematical calculation of a combined value, the abstract idea of a mental process of a comparison and a law of a nature (the correlation of protein levels with amyloid-positive dementia) into a patentable application.
The claims are ineligible because the claims recite at least one judicial exception, i.e., abstract idea of a mathematical calculation (combined value), an abstract idea of a mental process (comparing a combined value for markers to a control value to identify an individual), and a law of nature (the correlation of protein levels with amyloid-positive dementia). Moreover, the claims as a whole do not integrate the judicial exceptions into a practical application nor do they provide an inventive concept.
These judicial exceptions are not integrated into a practical application because the additional limitations of the claims, i.e., the data gathering steps to identify an individual as having or being at risk of developing an amyloid-positive dementia, do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
None of the dependent claims recite limitations that integrate the judicial exception into a practical application. For example, claims 2-3 are each listing one judicial exception of an abstract idea of a mathematical calculation which are still not integrating the judicial exceptions into a practical application. Similarly, claims 15-16 are each listing one judicial exception of a mathematical calculation. Claims 2-3 and 15-16 do not have steps or elements that could integrate the judicial exceptions into a practical application because they do not amount to more than the judicial exceptions themselves, analogous to Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012). Furthermore, the claims do not act on or use the judicial exceptions in any further steps as required by MPEP 2106.04(d).
Moreover, the claims do not include additional elements that are sufficient to significantly amount to any added inventive concept to the judicial exceptions as detailed in MPEP § 2106.05(d). The detection and measurement of protein markers in blood is a well-understood, routine and conventional step that does not add an inventive concept to the judicial exceptions as cited above.
Per MPEP2106.05(f), another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court; in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do “‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’”. Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984 (warning against a § 101 analysis that turns on “the draftsman’s art”). In the instant case, claims 1 and 13 are simply reciting the judicial exceptions of an abstract idea of a mathematical calculation of a combined value, the abstract idea of a mental process of a comparison and a law of a nature (the correlation of protein levels with amyloid-positive dementia) without any integration into a practical application nor do they include additional elements that are sufficient to amount to significantly more than the judicial exceptions.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?)
This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03. Regarding claims 1 and 13 of the instant application and per Step 1, the claims are respectively directed to a statutory class of a method of “identifying an individual as having or being at risk of developing an amyloid-positive dementia” or “detecting an individual with an increased value for a marker combination” (Step 1: YES).
(Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?)
Regarding claim 1 of the instant application and per Step 2A, prong 1, the claim recites a judicial exception of calculating a “combined value” after measuring the marker molecules at the protein levels and according to broadest reasonable interpretation, an arithmetic calculation of a combination is also required to obtain “combined value” which is used to identify a patient of having or being at risk of developing an amyloid-positive dementia and an abstract idea of a mental process (comparing a combined value for markers to a control value to identify an individual), and a law of nature (the correlation of protein levels to amyloid-positive dementia).
Likewise, claim 13 is reciting an abstract idea of a mathematical calculation “combined value” and an abstract idea of a mental process (comparing a combined value for markers to a control value).
(Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?)
Regarding claims 1 and 13 of the instant application and per Step 2A, prong 2, the claims as a whole do not integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claims as a whole integrates the exception into a practical application. Claims 1 and 13 do not have additional elements that would integrate the judicial exceptions cited above into a practical application. The claims have steps of measuring marker molecules at the protein level to provide values for a “combined value” to compare to a “control value” to reach a diagnosis, and these steps do not integrate the judicial exception into a practical application because they are data gathering steps to use in the calculation and comparison, which do not add a meaningful limitation to the method as they are insignificant extra-solution activity. The claims only have a simple determination of a natural phenomenon and therefore, claims 1 and 13 do not integrate the judicial exceptions into a practical application.
(Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?)
Regarding claims 1 and 13 of the instant application and per Step 2B, this part of the eligibility analysis evaluates whether the claims as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim per MPEP 2106.05. Claims 1 and 13 of the instant application simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, such as measuring marker molecules at the protein level to provide values for a “combined value” with a commercially available assay such as with an immunoassay kit (Specification, page 6, lines 35-39; page 8, lines 9-18; page 9, lines 9-19). Furthermore, the claims themselves are recited at a high level of generality in which any assay can be used as the detection method for claims 1 and 13. Thus, claims 1 and 13 are not eligible and are rejected under 35 USC 101.
Regarding claims 2-3 the claims further provide a combined value which does not integrate the judicial exception into a practical application, nor do they amount to significantly more.
Regarding claim 4, the additional elements do not amount to more than the judicial exception of a mental process of comparing the combined value to a cut-off value to identify an individual of having or being at risk of developing an amyloid-positive dementia.
Regarding claim 5, the additional elements do not amount to more than the judicial exception of a mathematical calculation of weighting factors.
Regarding claim 6, the additional elements do not amount to more than the judicial exception of mathematical calculation for obtaining a control from a population.
Regarding claim 7, the additional elements do not amount to more than the judicial exception of mentally selecting a condition or a disease from a group.
Regarding claim 10, the additional elements do not amount to more than the judicial exception of a mental process of identifying a species as human.
Regarding claim 15-16 and 18, the claims further provide a weighted calculation which does not integrate the judicial exception into a practical application, nor do they amount to significantly more.
Regarding claim 17, the additional elements do not amount to more than the judicial exception of a mental process of identifying an individual.
Regarding claim 19, the additional elements do not amount to more than the judicial exception of mathematical calculation for obtaining a control from a population.
Regarding claim 20, the additional elements do not amount to more than the judicial exception of mentally selecting a condition or a disease from a group.
Regarding claim 21, the additional element does not amount to more than the judicial exception of mentally identifying a sample.
Regarding claim 22, the additional elements do not amount more than the judicial exception of mentally defining the measurement level.
Regarding claim 23, the additional elements do not amount to more than the judicial exception of a mental process of identifying an individual.
Regarding claim 24, the additional element does not amount to more than the judicial exception of mentally identifying a sample.
Claim 25 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim recites the judicial exception of a mental process of comparing (comparing the combined value to individual biomarker measurements or conventional Aβ42/Aβ40 ratio analysis). The claim does not integrate the judicial exception into a practical application nor does it include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art (PHOSITA) to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This rejection also applies to newly added claim 26 as was necessitated by the amendments introduced through the addition of new claims.
Claims 1, 4, 6-7, 10, 13, 17, 19-21 and 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Frölich et al. (Alzheimer's Research & Therapy (2017) 9:84) in view of Kasai et al. (PLOS ONE, April 10, 2017) and Mattsson et al. (Neurology. 2016 Oct 25;87(17):1827-1835).
Regarding claim 1, the claim recites:
“A method of identifying an individual as having or being at risk of developing an amyloid-positive dementia, the method comprising
a) measuring in a sample obtained from the individual the amount or concentration of the
marker molecules amyloid β40 (Aβ40), amyloid β42 (Aβ42) and total Tau (tTau),
wherein the marker molecules are measured at the protein level, and combining the
amount or concentration of the marker molecules into a combined value, and
b) identifying an individual as having or being at risk of developing an amyloid-positive
dementia by comparing the combined value for the markers determined in step (a) to
a control value, wherein an increased combined value relative to the control value is
indicative of the amyloid-positive dementia,
wherein the sample is a blood sample and is not a brain sample or a cerebrospinal fluid
sample”.
Regarding claim 1, Frölich teaches how to use a method for predicting an individual of having Alzheimer’s disease (AD) dementia (Abstract, background, line 7; background, paragraph 6). Frölich also teaches how to measure the concentration or the protein levels of the biomarkers of amyloid β40, amyloid β42 and total Tau in a sample (Abstract; page 4, left column, third paragraph). And Frölich teaches how to obtain a combined value of biomarkers (Page 5, methods, statistical analysis, second paragraph, third line, “The predictive accuracy of all possible combination”; page 6, Results, statistical comparison of the predictive power of biomarker combinations over individual biomarkers). Frölich also teaches how to predict an individual of having AD dementia by comparing the combined value to a control value to predict AD dementia (Page 4, right column, fourth and fifth paragraphs; page 5, methods, statistical analysis, second paragraph, third line, “The predictive accuracy of all possible combination”; page 10, discussion, fifth paragraph, “Diagnostic biomarkers for the cross-sectional diagnosis of AD dementia compared to controls should have a sensitivity and specificity above 80%”) .
Regarding claim 4, Frölich teaches how to predict an individual of having AD dementia if the combined value of biomarkers is above the cut-off value (Page 4, right column, fifth paragraphs). And Frölich teaches how to obtain a cut-off value per the recommendation of Standards for Reporting Diagnostic accuracy (STARD) criteria (Page 4, right column, fifth paragraph).
Regarding claim 6, Frölich teaches how to obtain a control value from a population (Hippocampal volume, second paragraph) and teaches how to select a value from a group of patients who have non-AD pathophysiology (Discussion, Page 11, sixth paragraph). Frölich also teaches how to select AD positive patients (Page 11, discussion, sixth paragraph) and how to have a combination of patients in their population (Page 11, discussion, sixth paragraph).
Regarding claim 7, Frölich teaches how to have normal individuals in their population (Methods, subjects) and how to look for cognitive decline in an individual (Methods, subjects). Frölich also teaches how to have patients with a mild cognitive impairment or with AD for their study (Methods, subjects).
Regarding claim 10, Frölich teaches how to have human subjects for their study (Methods, subjects and collecting, storage, and shipment of the samples).
Regarding claim 13, the claim recites:
“A method for detecting an individual with an increased value for a marker combination, the method comprising
a) measuring in a sample obtained from the individual the amount or concentration of the
marker molecules Aβ40, Aβ42 and tTau, wherein the marker molecules are measured
at the protein level, and combining the amount or concentration of the marker
molecules into a combined value, and
b) detecting an increased combined value for the markers determined in step (a) relative
to the combined value as established in one or more reference population(s) (control
value),
wherein the sample is a blood sample and is not a brain sample or a cerebrospinal fluid
sample”.
Regarding claim 13, Frölich teaches how to measure the protein levels of the biomarkers of Aβ40, Aβ42 and tTau in a sample (Methods, analysis of CSF biomarkers). Frölich also teaches how to obtain the combined value of biomarkers (Page 5, methods, statistical analysis, second paragraph, third line, “The predictive accuracy of all possible combination”; page 6, Results, statistical comparison of the predictive power of biomarker combinations over individual biomarkers). Frölich further teaches how to detect an increased combined value by comparing it to a reference combined value (Methods, outcome measure and predictors, second paragraph; page 10, discussion, fifth paragraph).
Regarding claim 17, Frölich teaches how to select AD positive patients (Page 11, left column, second paragraph) and how to predict an individual of having AD dementia if the combined value of biomarkers is above the cut-off value (Page 4, right column, fifth paragraph). Frölich further teaches how to obtain a cut-off value per the recommendation of STARD criteria (Page 4, right column, fifth paragraph).
Regarding claim 19, Frölich teaches how to obtain a control value from a population (Page 4 of 15, right column, second paragraph) and how to select from a group who have non-AD pathophysiology (Page 11, left column, second paragraph). Frölich further teaches how to have a combination of patients in their population (Page 11, left column, second paragraph).
Regarding claim 20, Frölich teaches how to have normal individuals in their population and how to look for cognitive decline in an individual (Page 3, Subjects, left and right column). Frölich further teaches how to have patients with a mild cognitive impairment or with AD in their study (Page 3, Subjects, left and right column).
Regarding claim 26, the claim recites:
“A method for measuring a panel of marker molecules in an individual who has or is
at risk of developing an amyloid-positive dementia, the method comprising
a) obtaining a blood sample from the individual, wherein the sample is not a brain
sample or a cerebrospinal fluid sample; and
b) determining a measurement for a panel of marker molecules in the sample, wherein
the panel comprises the marker molecules amyloid β40 (Aβ40), amyloid β42 (Aβ42), and
total Tau (tTau),
wherein the measurement comprises determining a level of each of the marker
molecules Aβ40, Aβ42, and tTau in the panel”.
Regarding claim 26, Frölich teaches a method for measuring a panel of marker molecules in an individual who has or is at risk of developing an amyloid-positive dementia (Abstract). And Frölich teaches determining a measurement for a panel of marker molecules of amyloid β40 (Aβ40), amyloid β42 (Aβ42), and total Tau (tTau) in the sample (Abstract; page 4, left column, third paragraph).
Regarding claims 1, 13 and 26 Frölich does not teach using a non-CSF sample. Regarding claims 1, 13, 21 and 26, Frölich does not teach how to use a blood sample. Regarding claim 24, Frölich does not teach how to use plasma as a sample.
Regarding claims 1, 13, 21, 24 and 26 Kasai teaches how to use a blood sample and a plasma sample (Materials and methods, clinical assessments and sample collection) to detect amyloid beta levels. Kasai also teaches that amyloid beta levels are detected in plasma as well (Page 1/16, Abstract, “We collected plasma from a peripheral vein (peripheral-plasma) and from the internal jugular vein (jugular-plasma) to estimate directly the efflux of soluble Aβ from the brain”)
Regarding claims 1, 13 and 26 Mattsson teaches how to measure tTau from plasma (Abstract, objective; page 1828, left column, second paragraph, “To clarify the role of plasma tau in AD, we used an ultrasensitive digital ELISA method in 2 large cohorts with 563 participants from a prospective North American study and 721 participants from a cross-sectional Swedish study”).
It would have been obvious for a PHOSITA at the time the application was filed to combine the blood detection method of Kasai with the prediction method of Frölich using Aβ40, Aβ42 and tTau to further extend the prediction model of AD dementia to blood samples because Kasai offered the convenience of detecting AD biomarkers, such as Aβ40 and Aβ42 in blood or plasma in response to therapy in patients with AD (Abstract). A skilled artisan would have been further motivated to combine the tTau measurement method of Mattson with the combined method of Kasai and Frölich because Mattson noted that there is a need for a less invasive and cheaper biomarker of AD pathology (Pages 1827-1828, “There is a great unmet need for less invasive and cheaper biomarkers of AD pathology”) and further noted that measurement of AD biomarkers such as tTau in plasma samples is just as predictable as measuring tTau in CSF samples (Page 1831, left column, second paragraph, “In a subgroup analysis, which should be regarded as exploratory, we found associations in the MCI group between plasma tau and CSF T-tau”). Frölich further noted that the combination of biomarkers may increase the predictive power of models (Abstract, background) and that their model has the advantage of using statistical testing to predict AD dementia in the near future compared to other models (Background). A skilled artisan would have had a reasonable expectation of success in adapting the methods of Frölich, Kasai and Mattsson for the detection and prediction of AD dementia because such an adaption of methods would have resulted in a predictable use of prior art elements according to their established functions as described in their methods and discussions. When known elements are simply arranged with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious. A PHOSITA would have had a reasonable expectation of success in combining the methods of Frölich, Kasai and Mattsson based on the methods being in the field of using biomarkers in patients who are having or at risk of developing AD dementia. When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 may bar its patentability. When considering obviousness of a combination of known elements, the operative question is thus “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (MPEP 2141. I.) In the instant case, it has been well established that each of the three protein markers of Aβ40, Aβ42 and tTau has diagnostic value in patients who are having or at risk of developing AD dementia (Frölich et al., Kasai et al. and Mattsson et al.). A skilled artisan would have been motivated to test the three markers from blood or plasma for convenience and to provide a combined value that can be compared to a reference value to increase the sensitivity and specificity of the diagnostic test of AD and possible dementia.
It would have been obvious for a PHOSITA to use the predictive model described by Frölich and to extend the model to blood or plasma samples as shown by Kasai and Mattsson because the statistical model will offer the short-term ability to predict the occurrence of AD and dementia in patients as shown by Frölich and the convenience of using blood samples as shown by Kasai and Mattsson.
Claims 2-3, 5, 15-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Frölich et al. (Alzheimer's Research & Therapy (2017) 9:84), Kasai et al. (PLOS ONE, April 10, 2017) and Mattsson et al. (Neurology. 2016 Oct 25;87(17):1827-1835) as applied to claims 1 and 13 above, and further in view of LaMorte et al. (Boston University School of Public Health, May 31, 2016).
Regarding claim 2, the claim recites:
“The method of claim 1, wherein the combined value is obtained by a regression model of the amount or concentration of the marker molecules in the samples”.
Regarding claims 2-3, 5, 15-16 and 18, the teachings of Frölich, Kasai and Mattsson are described previously.
Moreover, regarding claims 2-3 and 15-16, Frölich teaches how to obtain a combined value by weighted calculation (Results, statistical comparison of the predictive power of biomarker combinations over individual biomarkers). Frölich also teaches how to measure the concentration of β40 in a sample (Methods, analysis of CSF biomarkers). And Frölich teaches how to measure the concentration of β42 in a sample (Methods, analysis of CSF biomarkers). Frölich further teaches how to measure the concentration of total Tau in a sample (Methods, analysis of CSF biomarkers). Frölich teaches how to make statistical calculations using an equation (Methods, statistical analysis).
Furthermore, regarding claims 5 and 18, Mattsson teaches how to analyze one or more reference populations (Abstract, methods; methods, BioFINDER study design, participants, and measurements).
Regarding claims 2 and 15, Frölich does not teach obtaining a combined value by a regression model. Regarding claims 3 and 16, Frölich does not teach how to predict AD dementia using a regression model (i.e., v =a* [Aβ40] + b * [Aβ42] + c * [tTau] + d). Frölich does not teach how to use weighting factors (i.e., wherein a, b and c represent the weighting factors) and does not teach having an intercept in the equation (i.e., and d represents the intercept). Regarding claims 5 and 18, Frölich does not teach how to use weighting factors (i.e., wherein the weighting factors have been obtained). Frölich does not teach how to analyze one or more reference population (i.e., by analyzing one or more reference population(s)).
Regarding claims 2 and 15, LaMorte teaches how to use a linear regression equation with weighting factors and an intercept (Page 1, The Multiple Linear Regression Equation; page 3 of 5, Intercept) that can be used as a model for AD and dementia.
Regarding claim 3 and 16, LaMorte teaches how to include multiple variants in a multiple linear regression equation to predict a variable such as having AD (Multivariable methods, the multiple linear regression equation).
Regarding claims 5 and 18, LaMorte teaches how to use weighting factors (Page 1, b1, b2 … bp; page 2, “b1 is the estimated regression coefficient that quantifies the association between the risk factor X1 and the outcome”, “b2 is the estimated regression coefficient that quantifies the association between the potential confounder and the outcome”).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the multiple linear regression model of LaMorte with the combined methods of Mattsson, Kasai and Frölich to further apply the statistical models and equations of LaMorte in the prediction model of AD of Frölich from blood samples because LaMorte noted the ability of their multiple linear regression model to study or account for multiple variants as it has been done in the predictive model of Frölich (Identifying and controlling for confounding with multiple linear regression). The methods of Kasai and Mattsson offered the convenience of using blood for testing the three biomarkers of Frölich. A PHOSITA would have had a reasonable expectation of success in combining the methods of LaMorte, Mattsson, Kasai and Frölich based on the methods being in the field of assessing biomarkers to predict disease in patients who are having or at risk of developing AD dementia. A skilled artisan would have been motivated to adapt the multiple linear regression equation of LaMorte into the method of Frölich because LaMorte teaches that Linear regression is a simple algorithm that can be easily used to account for multiple confounding variables to give satisfactory results (Page 1, last paragraph).
It would have been obvious for a PHOSITA to use the predictive model of Frölich to offer a near future prediction of AD in a convenient manner as shown by Kasai and Mattsson and to account for multiple variants as shown by LaMorte.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Frölich et al. ( Alzheimer's Research & Therapy (2017) 9:84), Kasai et al. (PLOS ONE, April 10, 2017) and Mattsson et al. (Neurology. 2016 Oct 25;87(17):1827-1835) as applied to claims 1 and 13 above, and further in view of Kapasi et al. (Acta Neuropathol. 2017 August; 134(2): 171–186).
Regarding claim 23, the teachings of Frölich, Kasai and Mattsson are described previously.
Moreover, regarding claim 23, Kasai teaches how to study individuals with AD (Material and methods, study design, ethics statement, and subject recruitment).
Regarding claim 23, Frölich does not teach that the individuals have AD combined with other types of dementia.
Regarding claim 23, Kapasi teaches how to study individuals with other types of dementia (Mixed vascular and AD pathologies, first paragraph).
It would have been obvious for a PHOSITA at the time the application was filed to combine the dementia types of Kapasi with the combined methods of Mattsson, Kasai and Frölich extending the prediction model of AD to mixed types of dementia and their possibility to develop into AD because Kapasi noted the importance and need to recognize the role of mixed pathologies in the development of AD (Abstract), and the model of Frölich would benefit from including mixed pathologies to further account for factors that were not considered before. A PHOSITA would have had a reasonable expectation of success in combining the methods of, Kapasi, Mattsson, Kasai and Frölich based on the methods being in the field of using biomarkers in patients who are having or at risk of developing AD dementia.
It would have been obvious for a PHOSITA to extend the predictive model of Frölich to blood samples as shown by Kasai and to cover mixed dementia as shown by Kapasi because the predictive model will offer a convenient near future diagnosis as shown by Frölich using blood for collection as shown by Kasai and Mattsson and will account for other factors and pathologies as shown by Kapasi.
New Rejections
Claim Rejections - 35 USC § 112(b)
The text of those sections of Title 35, U.S. Code is previously discussed. Furthermore, the amendments introduced by the Applicant necessitated this new rejection.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 25, the term "superior" renders the claim indefinite because it is unclear what is meant by “superior diagnostic accuracy”. The Specification simply recites the term “superior” without any explanation of what is meant by “superior” (Page 2, lines 29-32; page 26, lines 8-9; page 27, lines 16-17; page 29, lines 4-5; page 30, lines 13-14). Therefore, a skilled artisan would not have been able to reasonably ascribe the scope of the invention from the claim language, and thus claim 25 is deemed indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Regarding claim 26, the new claim raises new issues with prior art and given the breadth of the claim, new art is brought in.
Claim 26 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lue et al. (Neurol Ther (2017) 6 (Suppl 1):S25–S36).
Regarding claim 26, the claim recites:
“A method for measuring a panel of marker molecules in an individual who has or is at risk of developing an amyloid-positive dementia, the method comprising
a) obtaining a blood sample from the individual, wherein the sample is not a brain sample or a cerebrospinal fluid sample; and
b) determining a measurement for a panel of marker molecules in the sample, wherein the panel comprises the marker molecules amyloid β40 (Aβ40), amyloid β42 (Aβ42), and total Tau (tTau),
wherein the measurement comprises determining a level of each of the marker molecules Aβ40, Aβ42, and tTau in the panel”.
Regarding claim 26, Lue teaches a method for measuring a panel of marker molecules in an individual who is at risk of developing an amyloid-positive dementia (Pages S29-S30, “Studies using IMR assays have mainly been … (Clinical Dementia Rating scores 0.5–3),”).
Lue teaches obtaining a blood sample from the individual (Page S29, right column, “The IMR and SIMOA assays were developed to increase the detection sensitivity of immunoassays, and they have been used to analyze plasma levels of Aβ and tau in human subject studies”; page S30, right column, second paragraph, “In this article, we focused on two new ultra-sensitive immunoaffinity-based technologies that offer promise for establishing Aβ and tau as blood biomarkers for AD”).
Lue teaches determining a measurement for a panel of marker molecules in the sample, wherein the panel comprises the marker molecules amyloid β40 (Aβ40), amyloid β42 (Aβ42), and total Tau (tTau) (Page S29, right column, second paragraph, “The IMR and SIMOA assays were developed to increase the detection sensitivity of immunoassays, and they have been used to analyze plasma levels of Aβ and tau in human subject studies”; page S29, right column, third paragraph, “The IMR assays performed to date in Taiwanese subjects have revealed elevated Aβ42 levels, reduced or no change in Aβ40 levels, and increased tau levels in patients with AD when compared to normal controls”).
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive.
Rejection of claims 3 and 16 under 35 U.S.C. 112(a) for lack of written description:
With respect to the 112 (a) rejection of claims 3 and 16, the Applicant argued that written description may be satisfied through various means, including disclosure of sufficient relevant identifying characteristics or functional descriptions when coupled with a known or disclosed correlation between function and structure.
This argument is not persuasive because the Applicant did not provide enough information on how to deduce the values of the weighing factors a, b, c and d of the equation.
The Applicant further argued that the Office conflates written description with enablement because the Office is asking for how the values of a, b, c and d are obtained.
This argument is not persuasive because the Office noted that the values for a, b, c and d are not described in the claims nor in the specification. The specification only recites that a, b, c and d are weighting factor that are calculated using an equation (Page 24, lines 14-18). The specification further shows some exemplary values for a, b, c and d such as in Table 1b of Example 4 without describing how the values were obtained (Page 25, Table 1b). Although there is literal support for a, b, c and d from the specification, the values for a, b, c and d are not sufficiently described as to provide written support for how to use the equation to obtain the combined value as claimed. As such, the written description is lacking in regards to a, b, c and d and it is not clear how to obtain their values.
The Applicant argued that the specification adequately conveys possession of the claimed subject matter through three complementary disclosures.
This argument is not persuasive because while there is literal support for a, b, c and d from the specification, the values for a, b, c and d are not sufficiently described as to provide written support for how to use the equation to obtain the combined value as claimed.
The Applicant argued that the claims recite standard statistical methodology in which the weighting factors a, b, c, and d are regression coefficients obtained through standard statistical methodology that is well known to persons of ordinary skill in biostatistics and diagnostic development.
This argument is not persuasive because the Applicant has included this equation as part of the claim and thus each element of the equation needs to be account for in the claims itself or in light of the specification. In the instant case, the Applicant is counting on the skill of the artisan without providing the necessary written information to use the equation and to obtain the combined value as claimed.
The Applicant argued that the Office is requiring specific numeric values that is improper.
This argument is not persuasive because the Office did not require the Applicant to provide numerical values for a, b, c, d. Although there is literal support for a, b, c and d from the specification, the values for a, b, c and d are not sufficiently described as to provide written support for how to use the equation to obtain the combined value as claimed. The description does not need to provide numerical values but how to obtain the values would be sufficient to fulfill the written description.
Thus, the previous rejection of claims 3 and 16 under 35 U.S.C. 112(a) regarding written description is maintained and is made final.
Rejection of claims 3 and 16 under 35 U.S.C. 112(b) for indefiniteness:
With respect to the 112 (b) rejection of claims 3 and 16, the Applicant argued that the specification provides support and written description for how to obtain the values of a, b, c and d and referenced the specification at page 13, lines 14-25, examples 3 and 4 and page 24, lines 14-18. This argument is not persuasive because none of the referenced examples in the specification show how the values of a, b, c and d are obtained.
This argument is not persuasive because claims 3 and 16 are claiming that the weighted calculation of the combined value is obtained by an equation (i.e., wherein the combined value v is obtained by weighted calculation … according to the equation: v =a* [Aβ40] + b * [Aβ42] + c * [tTau] + d). However, the equation requires the values for a, b, c and d which are not taught as described. The values for a, b, c and d are not described in the claims nor in the specification. The specification only recites that a, b, c and d are weighting factor that are calculated using an equation (Page 24, lines 14-18). The specification further shows a list of the values for a, b, c and d such as in Table 1b of Example 4 without describing how the values were obtained or how one of ordinary skill in the art should chose the correct value for use in the equations (Page 25, Table 1b). Although there is literal support for a, b, c and d from the specification, the values for a, b, c and d are not sufficiently described as to use in the equation for the weighted calculation of the combined value. As such, the claims are vague and written description is lacking (see new 112 (a) rejection above, in regards to a, b, c and d and it is not clear how to obtain their values.
Thus, the previous rejection of claims 3 and 16 under 35 U.S.C. 112(b), regarding indefiniteness, is maintained and is made final.
Rejection of claims 1-7, 10, 13, 15-21 and 23-24 under 35 U.S.C. 101:
Regarding the rejection of claims 1-10, 13 and 15-23 under 35 USC 101, Applicant argued that claim 1 combines the measurement of a unique combination of biomarkers and the determination of a weighted calculation of the amount of concentration of the unique combination of biomarkers, thus the claims provide additional elements that amount to significantly more than the alleged abstract idea itself.
This argument has been fully considered but is not persuasive because claim 1 is directed to the abstract idea of mathematical calculation (combined value), mental process (identifying an individual) and a law of nature (the correlation of protein levels with amyloid-positive dementia). Similarly, claim 13 is directed to the abstract idea of mathematical calculation (combined value) and a mental process (comparing the combined value to a control value). The claims describe the level of measurement for the marker molecules which does not integrate the judicial exception into a practical application because it does not amount to more than the judicial exception itself analogous to Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012). Furthermore, the claims describe combining the amount or concentration of the marker molecules into a “combined value” which does not integrate the judicial exception into a practical application because it does not amount to more than the judicial exception itself (abstract idea of mathematical calculation).
The Applicant argued in the response of 01/09/2026 that the remarkable combination of biomarkers is far superior over other known standard combinations and further argues that the claims of the instant application provide an inventive concept in view of the remarkable and novel combinations of biomarkers along with the determination of the of the weighted calculation of the amount or concentration of the unique combinations of biomarkers.
This argument is not persuasive because at the time the application was filed, it is routine and conventional for one to detect the three specific biomarkers and use the results to diagnose AD as was shown by Frölich (Abstract, background, line 7; background, paragraph 6; page 5, methods, statistical analysis, second paragraph, third line, “The predictive accuracy of all possible combination”; page 6, Results, statistical comparison of the predictive power of biomarker combinations over individual biomarkers). Thus, such a combination is routinely assessed at the time the application was filed. Furthermore, the combination of beta amyloids and tau protein in blood are discussed by Lue et al before the effective filing date of this application (Page S29, right column, second paragraph, “The IMR and SIMOA assays were developed to increase the detection sensitivity of immunoassays, and they have been used to analyze plasma levels of Aβ and tau in human subject studies”).
Furthermore, the Applicant argued in the response of 01/09/2026 that before the filing of the instant application, conventional assays in the field of amyloid-positive dementia use cerebrospinal fluid samples and not blood.
This argument is not persuasive because at the time the application was filed, conventional assays in the field of amyloid-positive dementia used blood in addition to cerebrospinal fluid as blood samples were used by Kasai to detect amyloid beta levels (Materials and methods, clinical assessments and sample collection) and Mattson to detect tTau (Abstract, objective; page 1828, left column, second paragraph, “To clarify the role of plasma tau in AD, we used an ultrasensitive digital ELISA method in 2 large cohorts with 563 participants from a prospective North American study and 721 participants from a cross-sectional Swedish study”). Also, Lue discussed using blood as a sample to measure the individual levels of amyloid beta and tau proteins using two different assays (Page S29, right column, second paragraph, “The IMR and SIMOA assays were developed to increase the detection sensitivity of immunoassays, and they have been used to analyze plasma levels of Aβ and tau in human subject studies”; page S30, right column, second paragraph, “In this article, we focused on two new ultra-sensitive immunoaffinity-based technologies that offer promise for establishing Aβ and tau as blood biomarkers for AD”).
Thus, the previous rejection of claims 1-7, 10, 13, 15-21 and 23-24 under 35 U.S.C. 101 is still maintained and is made final.
Rejection of claims 1, 4, 6-7, 10, 13, 17, 19-21 and 24 under 35 U.S.C. 103:
The Applicant argued against using References Frölich and Kasai for the previous rejection of claims under 35 U.S.C. 103 for the following reasons.
The Applicant argued that Frölich fails to teach that the sample is a blood sample and is not a brain sample or a cerebrospinal fluid sample. The Applicant further argued that Kasai does not teach such a deficiency of Frölich and that it teaches a one of the ordinary skill not to use plasma samples. The Applicant argued that Kasai does not teach that tTau could be measured in blood samples.
First, the Applicant argued that Frölich measures the markers of the instant application from CSF and that Kasai does not measure the markers of the instant application from plasma. However, Kasai clearly stated that amyloid beta levels are detected in plasma as well (Page 1/16, Abstract, “We collected plasma from a peripheral vein (peripheral-plasma) and from the internal jugular vein (jugular-plasma) to estimate directly the efflux of soluble Aβ from the brain”).
Second, the Applicant still argued that Kasai is not measuring all the markers of the instant application.
This argument is not persuasive because in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Mattsson was added to the 103 rejection to teach the ability of testing tTau from plasma samples (Abstract, objective; page 1828, left column, second paragraph, “To clarify the role of plasma tau in AD, we used an ultrasensitive digital ELISA method in 2 large cohorts with 563 participants from a prospective North American study and 721 participants from a cross-sectional Swedish study”; page 1831, left column, second paragraph, “In a subgroup analysis, which should be regarded as exploratory, we found associations in the MCI group between plasma tau and CSF T-tau”).
Third, the Applicant argued that Kasai showed how different sample types would produce different results, and thus the teaching of Frölich cannot be extended to non-CSF samples. However, a skilled artisan would have known that matrix effect needs to be considered in any measuring assay of biomarkers and would be accounted for accordingly.
The Applicant argued that one of ordinary skill in the art interested in using a much less invasive blood sample would have no motivation to select the Frölich and Kasai references, which both require a more invasive cerebrospinal fluid sample, and to combine such references in the particular manner alleged by the Office Action to reach the claimed method.
This argument is not persuasive because in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Kasai clearly teaches using amyloid β (Aβ) proteins from plasma and that they can serve as a direct precise biomarker to assess treatment in patients with AD (Abstract, “Aβ in jugular-plasma seems to be a more direct and precise biomarker to estimate clearance of Aβ from the brain rather than Aβ in peripheral-plasma”; page 2/16, “The primary objectives of this study are, firstly, to compare the levels of Aβ (Aβ40 and Aβ42) in plasma from a peripheral vein (peripheral-plasma) and from the internal jugular vein (jugular-plasma) during the treatment”). Furthermore, as stated above Mattsson teaches the ability of measuring tTau from plasma (Abstract, objective; page 1828, left column, second paragraph, “To clarify the role of plasma tau in AD, we used an ultrasensitive digital ELISA method in 2 large cohorts with 563 participants from a prospective North American study and 721 participants from a cross-sectional Swedish study”; page 1831, left column, second paragraph, “In a subgroup analysis, which should be regarded as exploratory, we found associations in the MCI group between plasma tau and CSF T-tau”). Thus, a skilled artisan would have been motivated by the teachings of Kasai and Mattsson to combine with the teachings of Frölich to arrive at the method of the instant application.
The Applicant argued that none of the References of LaMorte nor Kapasi were applied to cure the deficiency of Frölich and Kasai regarding sample type. The Applicant argued that LaMorte merely explains linear regressions and in no manner applies such linear regressions to Alzheimer's Disease studies. The Applicant argued that Kapasi discloses a "clinical-pathological perspective on the role of multiple brain pathologies in dementia" but does not appear to disclose using blood samples for doing so.
This argument is not persuasive because LaMorte and Kapasi are secondary references that are cited for their teaching of multiple linear regression and cofounding variables (LaMorte et al.) and mixed types of dementia and their possibility to develop into AD (Kapasi et al.). Furthermore, the combination of Mattsson, Kasai and Frölich renders the claimed invention obvious as detailed above, and the measurements of Aβ40, Aβ42 and tTau are also taught by Mattson, Kasai and Frölich as explained above.
The Applicant argued that Mattson teaches away from using a blood sample for measuring tTau. The Applicant argued that Mattson reports at pg. 1827 “Despite group-level differences, these results do not support plasma tau as an [Alzheimer’s Disease] biomarker in individual people.”
This argument is not persuasive because Mattson reports at pg. 1827 the following: “Plasma tau partly reflects AD pathology, but the overlap between normal aging and AD is large, especially in patients without dementia. Despite group-level differences, these results do not support plasma tau as an AD biomarker in individual people. Future studies may test longitudinal plasma tau measurements in AD”. Mattson further reports the following conclusions on page 1833 “We found associations between elevated plasma tau and AD hallmarks, but the associations were mild and differed between cohorts. Our longitudinal data suggest that high plasma tau is associated with rapid progression in later disease stages. The large study sample supports generalization of these results. Future studies should include longitudinal measurements to explore whether plasma tau is sensitive to intraindividual changes during the progression of AD and an assessment of plasma tau across neurodegenerative diseases. This would increase the usability of plasma tau as an AD biomarker, particularly in clinical trials for patient enrichment and stratification.”. Clearly, Mattson does not teach away from using plasma tau as an AD biomarker but provides a recommendation on how to use plasma tau in patients over time. Furthermore, the reference of Mattsson teaches the ability to test for plasma tau as compared to tTau in CSF (Page 1831, left column, second paragraph, “In a subgroup analysis, which should be regarded as exploratory, we found associations in the MCI group between plasma tau and CSF T-tau”).
The Applicant argued that the invention is predicated on an unexpected results, and that the specification of the instant application demonstrates that the three-biomarker combination achieves superior diagnostic accuracy compared to conventional approaches.
This argument is not persuasive because unexpected results typically involve synergism, an unpredictable phenomenon that is highly dependent upon specific proportions and/or amounts of particular ingredients. Any mixture of the components embraced by the claims which does not exhibit an unexpected result, e.g., synergism, is therefore ipso facto unpatentable. In order to properly evidence unexpected results, a declaration should have explicit descriptions of all test conditions, i.e., precisely what was done should be recited in the declaration (actual steps carried out, materials employed, all amounts of reagents used, etc. Nothing should be left to conjecture. In order for the comparison to be valid, the closest prior art and the claimed invention must be tested under substantially the same conditions. Furthermore, MPEP 716.02 (b) teaches that the burden is on applicant to establish their results are unexpected and significant. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) Applicant is merely concluding that their results are superior without showing statistical and practical significance. See MPEP 716.02 for direction on how to properly establish unexpected results for the claimed invention. To be of probative value, objective evidence of unexpected results must be factually supported by actual proof. See MPEP 716.01(c). Note also that arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). In this case, the comparison between the closest prior art and the instant invention is not done under the same experimental conditions and as part of a declaration. Additionally, the claims are generic to any assay and reagent to use. Thus, the claims do not have supportive evidence of unexpected results.
Thus, the previous rejection of claims 1, 4, 6-7, 10, 13, 17, 19-21 and 24 under 35 U.S.C. 103, regarding obviousness, is maintained and is made final.
Also, Applicant's amendments necessitated the new grounds of rejection presented in this Office action to newly added claims 25-26.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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