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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/16/2025 has been entered.
Withdrawn Election/Restriction Requirements
In the Office action posted 6 February 2024, Applicant elected “miR-18” of claim 1 and “developing a quantitative algorithm to determine the extent, severity, or stage of disease” of claim 2 in response to species restriction requirements (in addition to a group restriction requirements). Thereafter, Applicant has not canceled other species in claims 1 and 2.
During the course of examination, it becomes clear that miR-18 along would make a bad biomarker for endometriosis. miR-18 has been reported to be involved in several other cancer development but not in endometriosis. Rejoining of other micro-RNA species is beneficial to the current invention.
Hence, upon further consideration, the species restriction requirement applied upon claim 1 in the 6 February 2024 Office action is herein withdrawn. All the micro-RNA species listed in the 10/16/2025 version (the current version) of claim 1 step a) will be considered and examined.
Including additional species in claim 1 makes other species in claim 2 possible, as a consequence. Upon further consideration, the species restriction requirement applied upon claim 2 in the 6 February 2024 Office action is herein withdrawn.
In summary, the species restrictions applied on the in the 6 February 2024 Office action are withdrawn. Claim 1 and 2 will be examined in full as presented on the 10/16/2025 version (the current version).
Status of Claims
Claims 3, 6, 8-11, 23 and 27-46 are cancelled.
Claims 1, 2, 4-5, 7, 12-13, 15-22 and 24-26 are pending.
Claims 4, 5, 7, 12, 13, 15-22 and 24-26 are withdrawn.
Claims 1, 2, and 14 are pending and are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of US application 62/753,265 filed 10/31/2018 is acknowledged.
Claim Rejections - 35 USC § 101
This rejection is maintained from the previous Office action. Modifications are necessitated by claim amendments.
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.
Claims 1-2 and 14 are rejected under 35 USC 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claim 1 ,2 and 14 are directed to a process, here a "method," for assessing endometriosis, with process steps like "inputting”, “assessing”, “combining", “assigning”, “using” (or “to develop”), “obtaining” and “administering”.
Step 2A Prong One: Identification of Abstract Ideas
Claim 1 recites:
a) inputting a level of at least one miRNA into an algorithm, wherein the at least one miRNA is selected from the group consisting of miR-18.
---- Inputting data into an algorithm is interpreted as part of the mathematical operation (as the algorithm is directed to math). Therefore this step equates to abstract ideas of mathematical concepts.
b) quantitatively assessing the performance of the at least one miRNA or the algorithm using receiver operating characteristic (ROC) analysis and understanding AUC (Area Under the Curve),
----This element recites mathematical calculation (“quantitatively assessing”) and mathematical concepts (“receiver operating characteristic (ROC) analysis and understanding AUC (Area Under the Curve)”), which can be done in human mind with the help of a pen/paper. Additionally “understanding AUC” reads on a mental activity. Hence this element equates to an abstract idea of mathematical concepts and mental processes.
c) combining at least one of the at least one miRNA into a mathematical formula,
---- This element recites mathematical calculation (“combining at least one of the at least one miRNA into a mathematical formula”), which can be done in human mind with the help of a pen/paper under a BRI. Hence this element equates to an abstract idea of mathematical concepts and mental processes.
d) assigning weights to at least one of the at least one miRNA within the formula, and
---- This element recites data manipulation (“assigning weights …”), hence this element equates to an abstract idea of mental processes.
e) using the assigned weights to develop a quantitative algorithm to distinguish the presence or absence of endometriosis.
---- This element recites a mathematical operation (“to develop a quantitative algorithm …”), which can be done in human mind with the help of a pen/paper under a BRI. Hence this element equates to an abstract idea of mathematical concepts and mental processes.
f) obtaining results derived from a quantitative algorithm for endometriosis;
---- Outputting data from an quantitative algorithm is interpreted as part of the mathematical operation (as the quantitative algorithm is directed to math). Therefore this step equates to abstract ideas of mathematical concepts.
g) administering a therapeutic agent for the treatment of endometriosis to a subject in need thereof identified by the quantitative algorithm as having endometriosis, wherein the therapeutic agent is selected from the group consisting of hormone therapy, chemotherapy, and immunotherapy.
----The limitation "a subject in need thereof identified by the quantitative algorithm as having endometriosis” correlates the quantitative result of biomarkers with having endometriosis or not. The step is hence directed to law of nature.
Dependent claims 2 and 14 recite more elements that are directed to abstract ideas in the mental process grouping and in the mathematical concept grouping.
The claims must therefore be examined further to determine whether the claims integrate the above-identified abstract ideas into a practical application (MPEP 2106.04(d)).
Step 2A Prong Two: Consideration of Practical Application
The claims result in a process of “g) administering a therapeutic agent for the treatment of endometriosis to a subject in need thereof identified by the quantitative algorithm as having endometriosis, wherein the therapeutic agent is selected from the group consisting of hormone therapy, chemotherapy, and immunotherapy.” However, there is no direct relation between the “subject” here at step g) and the “inputting a level of at least one miRNA” in step a). Claim 1 as recited, there is no subject sampled for miR-18 expression level and hence there is actually no subject determined to have endometriosis. The input level of miR-18 recited in claim 1 step a) has nothing to do with any subject. The abstract idea is directed to determining an output from a quantitative algorithm that is not bounded to any subject.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
administering a therapeutic agent for the treatment of endometriosis to a subject in need thereof identified by the quantitative algorithm as having endometriosis, wherein the therapeutic agent is selected from the group consisting of hormone therapy, chemotherapy, and immunotherapy (claim 1 step g).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not include additional elements that are sufficient to amount of significantly more than the judicial exception because treating a subject with endometriosis using a therapeutic agent of hormone therapy, chemotherapy, or immunotherapy, is considered routine and conventional in clinical industry.
Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Applicant’s Arguments
In the Remarks filed 10/16/2025, Applicant argued (page 11, penultimate para through page 13, 4th para) that claims 1, 2 and 14 are not directed to a judicial exception. Applicant's arguments have been fully considered but they are not persuasive.
In response, Applicant’s argument refers to Step 2A/Prong two in the 101 analysis, relating to whether the therapeutic agent treatment of endometriosis integrates claims into a practical application or not. As discussed above, claim 1 last step do recite (emphasis added) “g) administering a therapeutic agent for the treatment of endometriosis to a subject in need thereof identified by the quantitative algorithm as having endometriosis, wherein the therapeutic agent is selected from the group consisting of hormone therapy, chemotherapy, and immunotherapy.” However, there is no direct relation between the “subject” here at step g) and the “inputting a level of at least one miRNA” in step a). Claim 1 as recited, there is no subject sampled for miR-18 (or any other micro-RNA) expression level and hence there is actually no subject determined to have endometriosis. The abstract idea is directed to determining an output from a quantitative algorithm which is not bounded to any subject.
Therefore, at Step 2A/Prong two, claims are not integrated into a practical application.
In the Remarks, Applicant argued (page 13, 5th para through page 14, 1st para) that claims 1, 2 and 14 recite “significantly more than the judicial exception”. Applicant's arguments have been fully considered but they are not persuasive.
Under Step 2B, the additional element “administering a therapeutic agent for the treatment of endometriosis to a subject in need thereof identified by the quantitative algorithm as having endometriosis, wherein the therapeutic agent is selected from the group consisting of hormone therapy, chemotherapy, and immunotherapy” (claim 1 step g) is considered routine and conventional. Treating endometriosis patients with a therapeutic agent selected from the group consisting of hormone therapy, chemotherapy, and immunotherapy is a routine practice in the clinical industry.
Therefore, the claims do not recite anything significantly more. Consequently, claims are not integrated into a practical application and the claims are not eligible under 35 USC 101.
Double Patenting
This rejection is newly installed. Necessitated by claim amendments.
Claims 1-2 of this application is patentably indistinct from claims 8-10 and 22 of Application No. US 10982282B2. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-10 and 22 of U.S. Patent No. US 10982282B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the missed part in reference claims regarding the quantitative analysis of biomarkers are provided in the following disclosure (emphasis added):
(col 37, 2nd para through col 38, 1st para) Because the level of circulating miRNA in a test sample from a patient relates to the prognosis of a patient in a continuous fashion, the determination of prognosis can be performed using statistical analyses to relate the determined circulating miRNA levels to the prognosis of the patient. A skilled artisan is capable of designing appropriate statistical methods. For example, the methods may employ the chi-squared test, the Kaplan-Meier method, the log-rank test, multivariate logistic regression analysis, Cox's proportional-hazard model and the like in determining the prognosis. Computers and computer software programs may be used in organizing data and performing statistical analyses. The approach by Giles et. al., British Journal of Hemotology, 121:578-585, is exemplary. As in Giles et al., associations between categorical variables (e.g., miRNA levels and clinical characteristics) can be assessed via cross-tabulation and Fisher's exact test. Unadjusted survival probabilities can be estimated using the method of Kaplan and Meier. The Cox proportional hazards regression model also can be used to assess the ability of patient characteristics (such as miRNA levels) to predict survival, with ‘goodness of fit’ assessed by the Grambsch-Therneau test, Schoenfeld residual plots, martingale residual plots and likelihood ratio statistics (see Grambsch et al, 1995). In some embodiments, this approach can be adapted as a simple computer program that can be used with personal computers or personal digital assistants (PDA). The prediction of patients' survival time in based on their circulating miRNA levels can be performed via the use of a visual basic for applications (VBA) computer program developed within Microsoft Excel. The core construction and analysis may be based on the Cox proportional hazard models. The VBA application can be developed by obtaining a base hazard rate and parameter estimates. These statistical analyses can be performed using a statistical program such as the SAS proportional hazards regression, PHREG, procedure. Estimates can then be used to obtain probabilities of surviving from one to 24 months given the patient's covariates. The program can make use of estimated probabilities to create a graphical representation of a given patient's predicted survival curve. In certain embodiments, the program also provides 6-month, 1-year and 18-month survival probabilities. A graphical interface can be used to input patient characteristics in a user-friendly manner. In some embodiments of the disclosure, multiple prognostic factors, including circulating miRNA level, are considered when determining the prognosis of a patient. For example, the prognosis of an endometriosis subject or may be determined based on the presence of miRNA in a body fluid and one or more prognostic factors selected from the group consisting of cytogenetics, performance status, age, gender and previous diagnosis. In another example, the prognosis of a cancer patient may be determined based on circulating miRNA and one or more prognostic factors selected from the group consisting of cytogenetics, performance status, age, gender and previous diagnosis. In certain embodiments, other prognostic factors may be combined with the circulating miRNA level or other biomarkers in the algorithm to determine prognosis with greater accuracy.
(col 44, 2nd para) Assessment of the Diagnostic Value of Circulating miRNAs in Endometriosis
The ROC curve analysis of serum miRNAs that were differentially expressed between the two groups, was performed. AUC values of the differentially expressed miRNAs are shown in Table 2 and FIG. 3. Among the differentially expressed miRNAs, miR-125b-5p expression levels had the highest AUC (0.974, 95% Confidence Interval [CI], 0.00-1.00, p<0.001), with a sensitivity and specificity of 100% and 96%, respectively, for the cut off value of 0.0688. miRNA expressions in diagnosing endometriosis was improved by applying a logistic regression model to data with disease versus control samples. Since the distributions of all the biomarkers were not skewed normally, the variables were logarithmically transformed (FIGS. 3A-3C). A high AUC was observed for miR-125b-5p alone. A further increase in the AUC to 1.000 was achieved when combining the predictors 125b-5p, 451a and 3613-5p (FIG. 3D). The sensitivity and specificity reached 100% when these three microRNAs were combined. Therefore, the combination of micro RNAs demonstrated improved diagnostic ability over any individual micro RNAs. The following logistic model was selected: miRNA combination=118.406+108.751×log 10(125b-5p)+41.015×log 10(451a)−57.935×log 10(3613-5p). The microarray data shown in Table 3 demonstrates the top miRNA hits and the comparison of endometriosis (E1) upregulation vs. control (C1), E1 downregulation vs. C1.
The highlighted part clearly teaches a mathematical formula for quantifying the miRNA measurement for diagnostic/prognostic decisions. Therefore, instant claims 1 is obvious over the combination of explicit claims 8 and 22, plus the disclosure discussed above.
Claim Rejections - 35 USC § 103
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.
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 to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Cosar et al. ("Serum microRNAs as diagnostic markers of endometriosis: a comprehensive array-based analysis." Fertility and sterility 106.2 (2016): 402-409. Cited on the 4/5/2024 IDS), in view of Taylor et al. (“Circulating MicroRNA As Biomarkers For Endometriosis”, US 20170175190 A1, Date Published: 2017-06-22. Cited on the 4/5/2024 IDS).
Claim 1 is interpreted as a method to assess endometriosis quantitatively. Regarding claim 1, Cosar discloses a method to asses endometriosis using serum microRNAs. Particularly,
Cosar provides (page 402, Section Abstract) “miRNA from women with without endometriosis were used for microarray profiling and confirmed by means of quantitative real-time polymerase chain reaction (qRT-PCR). Receiver operating characteristic (ROC) analysis was performed on differentially expressed miRNAs. Result(s): miR-3613-5p, miR-6755-3p were down-regulated and miR-125b-5p, miR-150–5p, miR-342-3p, miR-143-3p, miR-145-5p, miR-500a-3p, miR-451a, miR-18a-5p were up-regulated more than 10-fold in the microarray. These results were confirmed with the use of qRT-PCR”, which teaches a) inputting the levels of miR-125b-5p, miR-150–5p, miR-342-3p, miR-143-3p, miR-145-5p, miR-500a-3p, miR-451a, and miR-18a-5p into the ROC algorithm.
Cosar provides (page 402, Section Abstract) “Result(s): miR-3613-5p, miR-6755-3p were down-regulated and miR-125b-5p, miR-150–5p, miR-342-3p, miR-143-3p, miR-145-5p, miR-500a-3p, miR-451a, miR-18a-5p were up-regulated more than 10-fold in the microarray. These results were confirmed with the use of qRT-PCR. Among the differentially expressed miRNAs, miR-125b-5p expression levels had the highest area under the ROC curve (AUC). The maximum AUC score of 1.000 was achieved when combining miR-125b-5p, miR-451a, and miR-3613-5p with the use of a logistic regression model.”, which teaches b) quantitatively assessing the performance of miRNAs using ROC analysis and understanding AUC.
Cosar provides (page 406, col 1, 1st para) “To improve the performance of miRNA expressions in diagnosing endometriosis, we applied the logistical regression model to the data for disease versus control samples. Because the distributions of the biomarkers were not skewed normally, the variables were logarithmically transformed (Fig. 3A). A high AUC was observed only for miR-125b-5p. A further increase in the AUC to 1.000 was achieved when combining the predictors 125b-5p, 451a, and 3613-5p (Fig. 3B). Sensitivity and specificity both reached 100% when these three miRNAs were combined. Therefore the combination of miRNAs may offer slightly improved diagnostic ability than any individual micro RNAs. The following logistic model was selected:
miRNA combination = 118.406
+ 108.751 x log10(125b-5p)
+ 41.015 x log10(451a)
+ 57.935 x log10(3613-5p)”
and Figure. 3B (page 407, Fig. 3B).
Therefore, Cosar teaches:
c) combining at least one of the at least one miRNA into a mathematical formula,
d) assigning weights to at least one of the at least one miRNA within the formula, and
e) using the assigned weights to develop a quantitative algorithm to distinguish the presence or absence of endometriosis.
f) obtaining results derived from a quantitative algorithm for endometriosis;
However, Cosar does not teach treating of endometriosis.
Taylor provides (paragraph [0126]) “once a patient is diagnosed with having or is at risk of having endometriosis, the patient can be treated using methods known in the art. Well known treatments for endometriosis include, but are not limited to, pain killers, hormonal treatments, chemotherapy, and surgical treatments”, which teaches g) hormone therapy and chemotherapy for women with endometriosis.
Regrading claim 2, Cosar does not teach determining whether a subject will respond to a treatment or not. Taylor provides (paragraph [0029]) “the present disclosure provides biomarkers for the diagnosis and prognosis of endometriosis. Generally, the methods of this disclosure find use in diagnosing or for providing a prognosis for endometriosis by detecting the expression levels of biomarkers, which are differentially expressed (up- or down-regulated) in blood, plasma or serum from a patient. Similarly, these markers can be used to diagnose reduced fertility in a patient with endometriosis or to provide a prognosis for a fertility trial in a patient suffering from endometriosis. The present disclosure also provides methods of identifying a compound for treating or preventing endometriosis. The present disclosure provides kits for the diagnosis or prognosis of endometriosis”, which teaches iv) developing a quantitative algorithm to determine whether a patient is likely to respond to a particular medical or surgical treatment,
It would have been prima facie obvious to Cosar’s method of quantitative assessment of endometriosis using non-invasive microRNA biomarkers and Taylor’s method of treating endometriosis patients with a hormonal treatment, or chemotherapy. Because treatment of patient is the natural next step after diagnosis or prognosis and Taylor’s method is established in the field of endometriosis treatment for years.
One would reasonably expect success as Cosar pointed out that (page 406, col 1, 2nd para. Emphasis added) “endometriosis is associated with a 6.7-year average diagnostic delay, resulting in progression of the disease and impairment in quality of life (39). Early diagnosis of endometriosis would allow prompt treatment, improvement in quality of life, and potentially preservation of fertility.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cosar et al. and Taylor et al., as applied to claims 1-2 above, and further in view of Taylor et al. ("Infrared spectroscopy with multivariate analysis to interrogate endometrial tissue: a novel and objective diagnostic approach." British journal of cancer 104.5 (2011): 790-797. Newly cited. Hereafter “Taylor SE”).
Regarding claim 14, Cosar et al. and Taylor et al. teach claims 1-2 above. Neither Cosar nor Taylor teaches the Fisher discriminant analysis. Taylor SE provides (page 790, Section Abstract) “derived data was subjected to principal component analysis followed by linear discriminant analysis”, which teaches the Fisher discriminant analysis because linear discriminant analysis is the Fisher discriminant analysis.
It would have been prima facie obvious to modify the mathematical method (Cosar: page 406, col 1, 1st para) used in the combined Cosar’s and Taylor’s method of quantitative assessment of endometriosis using microRNA biomarkers followed by treating endometriosis patients with hormonal treatments, or chemotherapy. Because (Taylor SE: page 791, col 1, 1st para) “Linear discriminant analysis demonstrates separation between different categories” (such as different microRNAs).
One would reasonably expect success as Cosar, Taylor and Taylor SE are all about endometrial diseases and Taylor SE already demonstrated that his approach is possible to distinguish benign from malignant endometrial tissue, and various subtypes of both. We can now expect the Fisher discriminant analysis algorithm (aka linear discriminant analysis) to different subject who have endometriosis from those who don’t have.
Conclusion
No claims are allowed.
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/GL/
Patent Examiner
Art Unit 1686
/Anna Skibinsky/
Primary Examiner, AU 1635