DETAILED ACTION
In application filed on 06/09/2023, Claims 1-20 are pending. The claim set submitted on 06/09/2023 is considered because this is the most recent claim set. Claims 1-5, 11-15 and 18 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/01/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of 1-5, 11-15 and 18 in the reply filed on 04/01/2026 is acknowledged. The traversal is on the ground(s) that:
Applicant respectfully requests reconsideration and withdrawal or modification of the restriction requirement. It is respectfully submitted that the inventions as claimed can be readily evaluated in one search without placing undue burden on the Examiner. That is, all the claims are so interrelated that a search of one group of claims will reveal art to the others.
Were restriction to be effected between the claims of Groups I-III, a separate examination of the claims in these three groups would require substantial duplication of work on the part of the U.S. Patent and Trademark Office. Even though some additional consideration would be necessary, the scope of analysis of novelty of all the claims of Groups I-III would have to be as rigorous as when only the claims of Group I, for example, were being considered by themselves. Clearly, this duplication of effort would not be warranted where these claims of different categories are so interrelated. Further, Applicant submits that for restriction to be effected between the claims in Groups I-III, it would place an undue burden by requiring payment of two separate filing fees for examination of the nonelected claims, as well as the added costs associated with prosecuting three applications and maintaining three patents.
This is not found persuasive because:
The inventions (Groups I-III) are independent or distinct as claimed as submitted in the Restriction requirement mailed to Applicant.
Examiner further submits that the inventions have acquired a separate status in the art in view of their different classification; and the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
As such a serious search burden exits on the Examiner if restriction were not required.
The requirement is still deemed proper and is therefore made FINAL.
Group I, Claims 1-5, 11-15 and 18 are considered on the merits below.
Claim Objections
Claims 2-3 and 13 are objected to because of the following informalities:
Claims 2-3 and 13 recites the limitation “CA125” in line 3, recites “mucin 16 (CA125)” in line 3 in Claim 1.
Consistent language should be uses and for the purpose of expedited prosecution, Examiner interprets “CA125” as “mucin 16 (CA125)”.
Appropriate correction is required.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to statutory categories, i.e., a method (Claim 1) (Step 1: YES).
Analysis:
Claim 1: Ineligible.
Step 1:
The claim recites a series of steps or acts, including “method for determining risk of ovarian cancer in a patient”. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES).
Step 2A, Prong 1:
Claim 1 recites “identifying that the patient is at risk of ovarian cancer based on the level of CA 125 and the level of SEZ6L”. Therefore, the claim is directed towards an abstract idea, and more specifically to the abstract idea group of a math or mental process since claim 1 relates to using a mental process to perform the steps reciting the abstract ideas.
In addition, it appears that limitation of Claim 1 further recites a Law of Nature because it describes the naturally occurring relationship between subject's risk for ovarian cancer and the levels of biomarkers CA125 and SEC6L. (Step 2A, Prong 1: YES).
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites ‘additional elements’ which are the steps performed before and after the recited abstract ideas. However, the steps before the abstract ideas are performed in order to gather data necessary to perform the determination step. Thus, these steps do not add a meaningful limitation since these steps are insignificant pre-solution activity.
It appears that the steps of “providing a biological …” and “measuring a level…” are recited at a high level of generality that they amount to mere data gathering (insignificant extra-solution activity). See MPEP 2106.05(g).
Accordingly, these steps are ‘additional elements’ which do not integrate the abstract ideas into a practical application because they do not impose meaningful limits on practicing the abstract ideas (Step 2A, Prong Two: NO).
Step 2B:
Furthermore, the courts have found that limitations adding insignificant extrasolution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see the 2014 Interim Guidance on Patent Subject Matter Eligibility of the Federal Register dated December 16, 2014; and MPEP 2106.05(I)(A)). Note that mere data gathering is not significantly more than the abstract idea. See MPEP 2106.05(g).
Here, there are no additional elements which are significantly more than the abstract idea.
The steps of “providing a biological …” and “measuring a level…” appear to be well-understood, routine, and conventional (WURC) in the field of Clinical Diganostics as evidenced by Gyllensten et al. (US20210255189A1) in view of Leandersson et al. ("A multiplex biomarker assay improves the diagnostic performance of HE4 and CA125 in ovarian tumor patients." PLoS One 15.10 (2020): e0240418., submitted in IDS on 04/01/2026).
Thus, the claims do not amount to significantly more (Step 2B: NO).
Therefore, Claim 1 is ineligible.
Moreover, Claims 2-5, 11-15 and 18 are rejected by virtue of dependency on Claim 1. Also, each of the dependent claims should be included in the 101 rejection as they do not solve the issues of claim 1.
Claim 2 and 4: Ineligible.
Step 2A, Prong One: Claim recites ““identifying…”; comparing…” with respect to the levels of CA125, SEZ6L, HE4 and ITGAV (mental and/or math steps), which is the abstract idea.
Step 2A, Prong Two: Once the steps of the steps of “identifying…”; comparing…” with respect to the levels of CA125, SEZ6L, HE4 and ITGAV are done, No further action takes place, much less a particular practical application.
Also the steps of “providing…” and “measuring…”(in claim 1) and “measuring” (in Claim 3) are recited at a high level of generality that it amounts to mere data gathering (insignificant extra-solution activity). See MPEP 2106.05(g).
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claims 2 and 4 are ineligible.
Claim 3: Ineligible.
Step 2A, Prong One: Claim recites “identifying that the patient…” (mental step), which is the abstract idea.
Step 2A, Prong Two: Once the step of “identifying that the patient…” is done, No further action takes place, much less a particular practical application. Also the steps of “providing…” and “measuring…”(in claim 1) are recited at a high level of generality that it amounts to mere data gathering (insignificant extra-solution activity). See MPEP 2106.05(g).
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claim 3 is ineligible.
Claims 5, 11-15 and 18: Ineligible.
Step 2A, Prong One and Prong Two: Claims 5, 11-15 and 18 further define the data gathering steps which appear to be generic and WURC.
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claims 5, 11-15 and 18 are ineligible.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 11-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over by Gyllensten et al. (US20210255189A1) in view of Leandersson et al. ("A multiplex biomarker assay improves the diagnostic performance of HE4 and CA125 in ovarian tumor patients." PLoS One 15.10 (2020): e0240418., submitted in IDS on 04/01/2026).
Regarding Claim 1, Gyllensten teaches a method for determining risk of ovarian cancer in a patient, the method comprising:
providing a biological sample (See Para 0274…‘a bodily fluid, preferably blood or a blood fraction…’) from the patient (See Para 0011…determining the level of a particular biomarker or of panels of particular biomarkers in a sample from a subject; See Para 0274…the subject sample may be a bodily fluid, preferably blood or a blood fraction such as blood plasma or serum, or may be lymph, cerebrospinal fluid, ascites fluid, peritoneal fluid or urine);
measuring a level of mucin 16 (CA125) in the biological sample (See Abstract…determining in a sample from said subject the levels of the biomarkers in a panel comprising: …MUC-16, …);
measuring a level of seizure 6-like protein (SEZ6L) in the biological sample (See Para 0012…determining in a sample from said subject the level of a biomarker selected from the list consisting of …, MUC-16, PTK7, SEZ6L, …); and
identifying that the patient is at risk of ovarian cancer (‘detecting, predicting or monitoring ovarian cancer in a subject’) based on the level of CA 125 and the level of SEZ6L (See Para 0012…detecting, predicting or monitoring ovarian cancer in a subject, comprising determining in a sample from said subject the level of a biomarker selected from the list consisting of …MUC-16, …, SEZ6L, …).
Regarding Claim 2, Gyllensten teaches wherein identifying comprises:
identifying a normal level of CA 125 (See Para 0266… levels of biomarkers determined in “control” samples; See Para 0236… determining the level of MUC-16 in a sample; See Para 0012… determining in a sample from said subject the level of a biomarker selected from the list consisting of…MUC-16,…SEZ6L…);
comparing the level of CA 125 (‘The levels of biomarkers which are determined in a sample from a subject who has ovarian cancer’) measured in the biological sample to the normal level (‘control’) of CA 125 (See Para 0266…The levels of biomarkers which are determined in a sample from a subject who has ovarian cancer may, therefore, be compared with the levels of biomarkers determined in “control” samples, and similarity to or divergence from the levels in a sample from a subject and a suitable control sample may be used to detect, monitor or predict ovarian cancer; See Para 0012… determining in a sample from said subject the level of a biomarker selected from the list consisting of…MUC-16,…SEZ6L…);
identifying that the level of CA 125 measured in the biological sample is greater than (‘higher’) the normal level of CA125 (See Para 0266… Where the determined level of a biomarker in a sample from a subject is different to the level of said biomarker in a control sample, the level in the sample from a subject may be higher or lower than the level in the control sample, depending on the particular biomarker in question; See Para 0012… determining in a sample from said subject the level of a biomarker selected from the list consisting of…MUC-16,…SEZ6L…);
identifying a normal level of SEZ6L (See Para 0266… levels of biomarkers determined in “control” samples; See Para 0012… determining in a sample from said subject the level of a biomarker selected from the list consisting of…MUC-16,…SEZ6L…);
comparing the level of SEZ6L (‘The levels of biomarkers which are determined in a sample from a subject who has ovarian cancer’) measured in the biological sample to the normal level (‘control’) of SEZ6L (See Para 0266…The levels of biomarkers which are determined in a sample from a subject who has ovarian cancer may, therefore, be compared with the levels of biomarkers determined in “control” samples, and similarity to or divergence from the levels in a sample from a subject and a suitable control sample may be used to detect, monitor or predict ovarian cancer; See Para 0012… determining in a sample from said subject the level of a biomarker selected from the list consisting of…MUC-16,…SEZ6L…); and
identifying that the level of SEZ6L measured in the biological sample is less (‘lower’) than the normal level of SEZ6L (See Para 0266… Where the determined level of a biomarker in a sample from a subject is different to the level of said biomarker in a control sample, the level in the sample from a subject may be higher or lower than the level in the control sample, depending on the particular biomarker in question; See Para 0012… determining in a sample from said subject the level of a biomarker selected from the list consisting of…MUC-16,…SEZ6L…).
Regarding Claim 3, Gyllensten teaches further comprising:
measuring a level of human epididymis protein 4 (HE4) in the biological sample (See Para 0012…determining in a sample from said subject the level of a biomarker selected from the list consisting of …, WFDC2; See Para 0009…known markers for ovarian cancer such as WFDC2/HE4); and
identifying that the patient is at risk of ovarian cancer based on the levels of CA125, SEZ6L and HE4 (See Para 0012…detecting, predicting or monitoring ovarian cancer in a subject, comprising determining in a sample from said subject the level of a biomarker selected from the list consisting of …MUC-16, …, SEZ6L…and WFDC2).
Gyllensten does not teach:
measuring a level of integrin alpha-V (ITGAV) in the biological sample; and
identifying that the patient is at risk of ovarian cancer based on the levels of CA125, SEZ6L, HE4, and ITGAV.
In the analogous art of a multiplex biomarker assay that improves the diagnostic performance of HE4 and CA125 in ovarian tumor patients, Leandersson teaches:
measuring a level of integrin alpha-V (ITGAV) (See Abstract, Results…We analyzed 177biomarkers…ITGAV) in the biological sample (See Abstract…Plasma samples were obtained from 180 women with ovarian tumors); and
identifying that the patient is at risk of ovarian cancer based on the levels of CA125, SEZ6L, HE4, and ITGAV (See Conclusion, Page 17, Findings, Pahe 9…ITGAV was the only individual biomarker found to improve the diagnostic performance of HE4, CA125 and age. Using LASSO regression, a multiplex model including 6 biomarkers (HE4, CA125, ITGAV, CXCL1, CEACAM1, IL-10RB) and age had the highest diagnostic accuracy for discrimination between benign ovarian tumors and EOC including borderline tumors; See Page 16…Lower plasma levels were found for ITGAVandCEACAM1inpatients with cancer compared to patients with benign tumors: See Page 5, Table 2 for SEZ6L).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Gyllensten to include “measuring a level of integrin alpha-V (ITGAV) in the biological sample; and identifying that the patient is at risk of ovarian cancer based on the levels of CA125, SEZ6L, HE4, and ITGAV” as taught by Leandersson for the benefit of determining that ITGAV was the only individual biomarker found to improve diagnostic performance of the reference model, to AUC 0.874 for benign tumors vs. cancer and AUC 0.818 for benign tumors vs. borderline tumors + cancer (p < 0.05) (Leandersson, Results, Page 1) and that ITGAV was the only individual biomarker found to improve the diagnostic performance of HE4, CA125 and age (Leandersson, Results, Page 17), allowing for providing a multiplex biomarker assay that improves the diagnostic performance of HE4 and CA125 in ovarian tumor patient (Leandersson, Title) and to determine that HE4 was the best performing individual biomarker for discrimination between benign ovarian tumors and EOC including borderline tumors (Leandersson, Conclusion, Page 2).
Regarding Claim 4, the method of claim 1 is obvious over Gyllensten in view of Leandersson.
Gyllensten further teaches identifying comprises:
identifying a normal level of HE4 (See Para 0266… levels of biomarkers determined in “control” samples; See Para 0012… determining in a sample from said subject the level of a biomarker selected from the list consisting of…WFDC2…);
comparing the level of HE4 (‘The levels of biomarkers which are determined in a sample from a subject who has ovarian cancer’) measured in the biological sample to the normal level (‘control’) of HE4 (See Para 0266…The levels of biomarkers which are determined in a sample from a subject who has ovarian cancer may, therefore, be compared with the levels of biomarkers determined in “control” samples, and similarity to or divergence from the levels in a sample from a subject and a suitable control sample may be used to detect, monitor or predict ovarian cancer; See Para 0012… determining in a sample from said subject the level of a biomarker selected from the list consisting of… WFDC2);
identifying that the level of HE4 measured in the biological sample is greater (‘higher’) than the normal level of HE4 (See Para 0266… Where the determined level of a biomarker in a sample from a subject is different to the level of said biomarker in a control sample, the level in the sample from a subject may be higher or lower than the level in the control sample, depending on the particular biomarker in question; See Para 0012… determining in a sample from said subject the level of a biomarker selected from the list consisting of… WFDC2).
Gyllensten does not further teach:
identifying a normal level of ITGAV;
comparing the level of ITGAV measured in the biological sample to the normal level of ITGAV; and
identifying that the level of ITGAV measured in the biological sample is less than the normal level of ITGAV.
In the analogous art of a multiplex biomarker assay that improves the diagnostic performance of HE4 and CA125 in ovarian tumor patients, Leandersson teaches:
identifying a normal level (‘ITGAV expression in plasma from patients with benign tumors’) of ITGAV (See Page 9, Our Findings… ITGAV expression was lower in plasma from patients with cancer compared with patients with benign tumors in our study);
comparing the level of ITGAV measured in the biological sample (‘ITGAV expression in plasma from patients with cancer) to the normal level (‘ITGAV expression in plasma from patients with benign tumors’) of ITGAV (See Page 9, Our Findings… ITGAV expression was lower in plasma from patients with cancer compared with patients with benign tumors in our study); and
identifying that the level of ITGAV measured in the biological sample (‘ITGAV expression in plasma from patients with cancer) is less than the normal level of ITGAV (See Page 9, Our Findings… ITGAV expression was lower in plasma from patients with cancer compared with patients with benign tumors in our study).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Gyllensten to include “identifying a normal level of ITGAV; comparing the level of ITGAV measured in the biological sample to the normal level of ITGAV; and identifying that the level of ITGAV measured in the biological sample is less than the normal level of ITGAV” as taught by Leandersson for the benefit of determining that ITGAV was the only individual biomarker found to improve diagnostic performance of the reference model, to AUC 0.874 for benign tumors vs. cancer and AUC 0.818 for benign tumors vs. borderline tumors + cancer (p < 0.05) (Leandersson, Results, Page 1) and that ITGAV was the only individual biomarker found to improve the diagnostic performance of HE4, CA125 and age (Leandersson, Results, Page 17), allowing for providing a multiplex biomarker assay that improves the diagnostic performance of HE4 and CA125 in ovarian tumor patient (Leandersson, Title) and to determine that HE4 was the best performing individual biomarker for discrimination between benign ovarian tumors and EOC including borderline tumors (Leandersson, Conclusion, Page 2).
Regarding Claim 5, the method of claim 1 is obvious over Gyllensten in view of Leandersson.
Gyllensten further teaches that the biological sample (See Para 0274…‘a bodily fluid, preferably blood or a blood fraction…’) comprises serum, whole blood, plasma, saliva, urine, mucus, ascites fluid, a cervical swab, a vaginal swab, fine needle aspirate, and/or biopsied cells (See Para 0274…the subject sample may be a bodily fluid, preferably blood or a blood fraction such as blood plasma or serum, or may be lymph, cerebrospinal fluid, ascites fluid, peritoneal fluid or urine).
Regarding Claim 11, the method of claim 1 is obvious over Gyllensten in view of Leandersson.
Gyllensten further teaches that the ovarian cancer is early-stage ovarian cancer (See Para 0258… Ovarian cancer diagnosed by such methods may be early stage ovarian cancer, e.g. stage I or stage II, or may be late stage ovarian cancer, e.g. stage III or stage IV).
Regarding Claim 12, the method of claim 1 is obvious over Gyllensten in view of Leandersson.
Gyllensten further teaches that the ovarian cancer comprises clear cell ovarian cancer, mucinous ovarian cancer, or endometroid ovarian cancer (See Para 0259… The type of ovarian cancer may be serous, endometriod, mucinous or clear cell tumours).
Regarding Claim 13, the method of claim 1 is obvious over Gyllensten in view of Leandersson.
Gyllensten further teaches that the method demonstrates higher sensitivity at a set specificity as compared to a method wherein only CA125 is analyzed (See Para 0096… We have identified that the use of MUC-16 as a biomarker for ovarian cancer in combination with other biomarkers was particularly useful in detecting, predicting or monitoring ovarian cancer in a subject, and in particular that such combinations provided a surprising improvement in the sensitivity and specific of the detection of ovarian cancer than the use of MUC-16 alone).
Regarding Claim 14, the method of claim 1 is obvious over Gyllensten in view of Leandersson.
Gyllensten further teaches providing a protein level (See Para 0012-0013…CPE) of one or more of SCF (UniProt ID No.: P21583), FASLG (UniProt ID No.: P48023), XPNPEP2 (UniProt ID No.: 043895), TCL1A (UniProt ID No.: P56279), VEGFR-2 (UniProt ID No.: P35968), CEACAMI (UniProt ID No.: P13688), TLR3 (UniProt ID No.: 015455), CYR61 (UniProt ID No.: 000622), GPNMB (UniProt ID No.:Q14956), CPE (UniProt ID No.: P16870), LY9 (UniProt ID No.: Q9HBG7), ERBB2 (UniProtID No.: P04626), GPC1 (UniProt ID No.: P35052), IFN-y-R1 (UniProt ID No.: P15260), CD48 (UniProt ID No.: P09326), RET (UniProt ID No.: P07949), ICOSLG (UniProt ID No.: 075144), CTSV (UniProt ID No.: 060911), and MIA (UniProt ID No.: Q16674) (See Para 0012-0013… Described herein are in vitro methods of detecting, predicting or monitoring ovarian cancer in a subject, comprising determining in a sample from said subject the level of a biomarker selected from the list consisting of…CPE…); and
identifying a patient (‘subject’) with below normal levels (See Para 0266… “control” samples) of the one or more proteins (‘CPE’) as at risk for ovarian cancer (See Para 0266… determining a low level of such biomarkers in a sample from a subject may therefore be indicative of ovarian cancer; See Para 0012-0013… …detecting, predicting or monitoring ovarian cancer in a subject, comprising determining in a sample from said subject the level of a biomarker selected from the list consisting of…CPE…; See Para 0266… Where the determined level of a biomarker in a sample from a subject is different to the level of said biomarker in a control sample, the level in the sample from a subject may be higher or lower than the level in the control sample, depending on the particular biomarker in question.).
Regarding Claim 15, the method of claim 1 is obvious over Gyllensten in view of Leandersson.
Gyllensten further teaches providing a protein level (See Abstract…biomarkers in a panel comprising: …FR-alpha, …) of one or more of MK (UniProt ID No.: P21741), IL6 (UniProt ID No.: P05231), ESM-1 (UniProt ID No.: Q9NQ30), hKl1 (UniProt ID No.: Q9UBX7), ADAM-TS 15 (UniProt ID No.: Q8TE58), SYND1 (UniProt ID No.: P18827), CXCL13 (UniProt ID No.: 043927), TFPI-2 (UniProt ID No.: P48307), FR-α (UniProt ID No.: P15328), KLK13 (UniProt ID No.: Q9UKR3), MSLN (UniProt ID No.: Q13421), NECT4 (UniProt ID No.: Q96NY8), TNFRSF6B (UniProt ID No.: 095407), FCRLB (UniProt ID No.: Q6BAA4), and AREG (UniProt ID No.: P15514) (See Abstract…biomarkers in a panel comprising: …FR-alpha, …); and
identifying a patient (‘subject’) with above normal levels (See Para 0266… “control” samples) of the one or more proteins as at risk for ovarian cancer (See Abstract…An in vitro method is provided for detecting, predicting or monitoring ovarian cancer in a subject, wherein said method comprises determining in a sample from said subject the levels of the biomarkers in a panel comprising: ….FR-alpha…; See Para 0266… Where the determined level of a biomarker in a sample from a subject is different to the level of said biomarker in a control sample, the level in the sample from a subject may be higher or lower than the level in the control sample, depending on the particular biomarker in question; See Para 0266…Conversely, the level of other biomarkers may be found to be higher in subjects who have ovarian cancer than in a healthy control group; determining a high level of such biomarkers in a sample from a subject may therefore be indicative of ovarian cancer).
Regarding Claim 18, the method of claim 1 is obvious over Gyllensten in view of Leandersson.
Gyllensten further teaches a system (See Para 0061… test kits and multianalyte panel assays comprising sets of reagents according to the present invention) for performing (See Para 0063…for the performing the method) the method of claim 1 (See Claim 1 rejection above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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