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.
Status of Claims
Claims 3 and 6-19 are pending and under examination. Claims 1-2 and 4-5 are canceled.
Withdrawn Rejections
In light of the amendments, the 35 U.S.C. 102(a)(1) rejection over Fukusumi et al. is hereby withdrawn.
In light of the amendments, the 35 U.S.C. 102(a)(1) rejection over Fehnel et al. is hereby withdrawn.
In light of the amendments, the 35 U.S.C. 102(a)(1) rejection over Takamura et al. is hereby withdrawn.
Claim Rejections - 35 USC § 112
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 10-19 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 10-19 are dependent from claim 1 but claim 1 has been canceled. Thus, it is unclear to the metes and bounds of the claimed invention as these claims are dependent from a canceled claim which is improper. For compact prosecution, these claims are dependent from claim 3.
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.
Claims 3, 6, 8, and 10-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and nature/natural phenomena without significantly more.
Step 1: The instantly claimed invention is directed to a method examining nephrotic syndrome comprising measuring an expression level of an Ephrin-B by contacting a urine sample of a subject with an isolated or non-naturally occurring antibody or Eph receptor that specifically binds to the Ephrin-B; (ii) determining a concentration of Ephrin-B1 in the urine sample by comparison to a reference standard: and (iii) diagnosing the subject as having nephrotic syndrome based on a determination that the concentration of Ephrin-B1 in the urine sample exceeds a predetermined threshold. Therefore, the instantly claimed invention falls into one of the four statutory categories. (Step 1: YES).
ELIGIBILITY STEP 2A; WHETHER A CALIM IS DIRECTED TO A JUDICIAL EXCEPTION. First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
STEP 2A: Prong One
Claim 3 recites the following steps which fall under abstract ideas and nature/natural phenomena: The claim is drawn to examining nephrotic syndrome and the natural correlation between nephrotic syndrome with Ephrin-B biomarker and the abstract ideas of determining a concentration of Ephrin-B1 in the urine sample by comparison to a reference standard: and (iii) diagnosing the subject as having nephrotic syndrome based on a determination that the concentration of Ephrin-B1 in the urine sample exceeds a predetermined threshold.
In particular, the limitations of determining a concentration of Ephrine-B1 and diagnosing the subject as having nephrotic syndrome are directed to the judicial exceptions because the claim language clearly conveys mental processes/concepts performed in the human mind (such as thinking). Such step would read on purely mental activity such as a practitioner looking at a subject’s chart and thinking about the concentrations of Ephrin-B and diagnosing the subject as having nephrotic syndrome. Additionally, the naturally occurring relationship between the levels of Ephrin-B and nephrotic syndrome in urine samples constitute law of nature/natural phenomena, as in urine samples the levels of Ephrin-B correlate with nephrotic syndrome.
With respect to claim 8, the limitation of the Ephrin-B is Ephrin-B1 is directed to the judicial exceptions. Claims 13-14 recite limitations that are directed to natural phenomena as Eph receptors naturally bind to Ephrin-B. Claims 15-16 recite limitations of determining the concentration of Ephrin-B 1 comprises generating a quantitative assay signal and comparing the assay signal to a calibration curve generated using reference standards containing known concentrations of Ephrin-B 1 and/or the predetermined threshold corresponds to a mean value, median value, or confidence interval of Ephrin-B 1 concentrations measured in urine samples of subjects without nephrotic syndrome are directed to the judicial exceptions. Claims 17-18 are directed to abstract ideas. Claim 19 is directed to the natural phenomena in human subjects.
STEP 2A: Prong Two
Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. Besides the natural phenomenon and mental processes limitations, claim 3 recites measuring an expression level of an Ephrin-B by contacting a urine sample of a subject with an isolated or non-naturally occurring antibody or Eph receptor that specifically binds to the Ephrin-B. Claims 10-11 recite the claimed immunoassays. Claim 12 recite the antibody is monoclonal antibody. Although these limitations indicate the active step of measuring, it does not provide any information on the purpose of measuring the expression level, but instead covers any possible reasons of measuring the expression level. Therefore, these limitations constitute to insignificant extra-solution activity (e.g., a mere data gathering step necessary to use the correlation). Detecting whether the intended biomarker is present in urine sample merely instructs a practitioner to use any immunoassay detection with generic antibodies for Ephrin-B and naturally produced Eph receptor. When so evaluated, this additional element represents mere for data gathering (obtaining information) that is necessary for use of the recited judicial exception and is recited at a high level of generality. There is no meaningful limitation such as a particular or unconventional element for data gathering.
With respect to claim 6, the claim is drawn to different buffers. The specification only discloses that the antibody is in a buffer solution. The specification does not provide any disclosure on the difference in structural properties between the substance in a buffer and lack thereof. Accordingly, the claimed combination does not mark different characteristics of the antibodies or Eph receptor when in a buffer solution and these limitations constitute to insignificant extra-solution activity for Ephrin-B to be measured. The recitation of the claimed buffer does not integrate the judicial exception into a practical application.
Accordingly, this judicial exception is not integrated into a practical application as indicated above (Step 2A Prong 2: NO).
STEP 2B:
In STEP 2B it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP 2106.05. The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception.
Feinberg et al. (WO2005/118878A2, published 12/15/2005) teach using the biological sample can include fluids such as urine (see bottom of para. [00130]). Feinberg teaches that the microarray of the invention comprises Ephrin-B1 biomarker in the biological sample (see para. [00132]). Feinberg teaches the antibodies are monoclonal antibodies (see pg. 56, claim 37 of Feinberg). Feinberg teaches measured and detected with Western blotting or ELISA (see para. [0068]). Feinberg also teaches biomolecules include EphB2 (see para. [0057]). Feinberg teaches the biomarkers can be labeled by capture biomolecule (see para. [00134]). Feinberg teaches the subject is human (see pg. 54, claim 24 of Feinberg).
Fehnel et al. (“Dysregulation of the EphrinB2−EphB4 ratio in pediatric cerebral arteriovenous malformations is associated with endothelial cell dysfunction in vitro and functions as a novel noninvasive biomarker in patients”, Experimental & Molecular Medicine (2020), vol 52, pgs. 658–671, published 04/14/2020, 892 dated 02/11/2026) teach investigating (1) EphrinB2 and EphB4 receptor expression (see abstract). Fehnel further teaches the expression of said Ephrin was assessed in urine (by ELSIA) from pediatric patients with AVM and EphrinB2 expression was increased in AVM tissue, which correlated with increased urinary EphrinB2 levels in AVM patients (see abstract).
Ghayur (WO2009/134776A3, published 11/05/2009) teaches monoclonal antibodies are highly specific, being directed against a single antigen (see pg. 74, lines 30-35). Ghayur teaches establishing calibration (standard) curves for interpolation of the concentration of an analyte such as an antibody or an analyte and a single calibrator which is near a predetermined positive/negative cutoff (see pg. 85, lines 32-37). Ghayur teaches a predetermined level as employed for monitoring disease progression and/or treatment, the amount or concentration of analyte (see pg. 181, lines 33-36). Ghayur teaches optimally the method comprises the steps of determining the concentration or amount in a test sample from a subject of analyte and determining the concentration or amount in a later test sample from the subject of analyte and comparing the concentrations (see pg. 183, lines 5-10). Ghayur teaches test sample such as urine (see pg. 186, lines 22-27).
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to the judicial exceptions without significantly more. For all of these reasons, the claims fail to include additional elements that are sufficient to amount to significantly more than the judicial exception(s).
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 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 3, 6-11, 13-14, 16-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Fukusumi et al. (“Nephrin-Binding Ephrin-B1 at the Slit Diaphragm Controls Podocyte Function through the JNK Pathway”, J. Am. Soc. Nephrol, vol. 29, pgs. 1462-1474, published 2018, IDS submitted 08/17/2023) in view of Nishi et al. (“Evidence-based clinical practice guidelines for nephrotic syndrome 2014”, Clin Exp Nephrol (2016) vol. 20, pgs. 342-370, 892 dated 02/11/2026) and Fehnel et al. (“Dysregulation of the EphrinB2−EphB4 ratio in pediatric cerebral arteriovenous malformations is associated with endothelial cell dysfunction in vitro and functions as a novel noninvasive biomarker in patients”, Experimental & Molecular Medicine (2020), vol 52, pgs. 658–671, published 04/14/2020, 892 dated 02/11/2026).
With respect to claims 1 and 7, Fukusumi teaches in Fig. 1 measuring and assessing Ephrin-B1 and Ephrin-B2 (Fig. 1A) and further measuring proteins in a urinary protein-to-creatinine ratio (Fig. C) (also see caption). Fukusumi teaches analyzed the expression of ephrin-B1 in human nephrotic syndrome and confirmed that ephrin-B1 was expressed in podocytes in normal human kidney materials and observed that the expression of the ephrin-B1 in glomeruli was clearly decreased in a patient with active MCNS (see page 1473, left col., para. 3). Fukusumi teaches compared with controls, ephrin-B1 conditional knockout mice displayed altered podocyte morphology (see abstract under results). Fukusumi teaches the kidney specimens were obtained from a patient with minimal change nephrotic syndrome treated at the hospital and as a control, we used the normal part of the kidney, obtained via nephrectomy (see pg. 1463, right col., last para. and Fig. 1A-C). Fukusumi teaches Ephrin-B1 staining in podocytes is clearly decreased in a human patient with active nephrotic syndrome (see pg. 1470, right col., para. 2). Fukusumi concluded that ephrin-B1 binds to nephrin via their extracellular domains and that the ephrin-B1-nephrin complex plays an essential role in maintaining the structure and barrier function of the slit diaphragm (see pg. 1473, left col., last para.).
However, Fukusumi does not explicitly teach measuring an expression level of Ephrin-B in urine sample, and determining and diagnosing the subject as having nephrotic syndrome based on a determination that the concentration of Ephrine-B1 in the urine sample exceeds a predetermined threshold (claim 3) and treating the subject whose expression level of the Ephrin-B in urine exceeds a preset reference value with an effective amount of a compound indicated for treating nephrotic syndrome (claim 7).
Fehnel teaches investigating (1) EphrinB2 and EphB4 receptor expression in cerebral AVM and the impact of an altered EphrinB2:EphB4 ratio on brain endothelia cell function (see abstract). Fehnel further teaches the expression of said Ephrin was assessed in urine (by ELSIA) from pediatric patients with AVM and EphrinB2 expression was increased in AVM tissue, which correlated with increased urinary EphrinB2 levels in AVM patients (see abstract). Fehnel also teaches post-treatment urinary EphrinB2 levels normalized in an index patient (see abstract). Fehnel teaches measurement of urinary EphrinB2 demonstrates clinical relevance as a biomarker and levels of EphrinB2 in urine were quantified using ELISA assay and results were normalized to overall urinary protein concentration and compared to levels from control patients (see pg. 663, right col., last para.).
Nishi teaches nephrotic syndrome (NS) (see pg. 342, left col. para. 1). Nishi teaches that nephrotic syndrome is a clinical syndrome showing specific features of heavy proteinuria as its consequence (see pg. 345, right col., para. 2). Nishi teaches that the effect of treatment is determined by the urinary protein level after treatment (see pg. 345, right col., bottom of para. 2, and Tables 2-3). Nishi teaches active clinical research on the treatment strategy that focuses on patients with NS using approved immunosuppressive agents (see pg. 345, left col., para. 5 under setting of necessary research themes in the future). Nishi teaches the classification by the response to treatment of nephrotic syndrome with compounds (see pg. 346, Table 3). Nishi teaches heathy persons (see pg. 355, left col., para. 1). Nishi teaches the addition of oral cyclosporine or cyclophosphamide to steroid is effective for the reduction of urinary protein level in frequently relapsing nephrotic syndrome in adults (see pg. 349, right col., para. 1). Nishi teaches at least 1 randomized controlled trial (see pg. 344, left col., para 2).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have continued to measure the presence or lack of Ephrin-B in urine sample of Fukusumi because Fukusumi recognizes that the expressions of Ephrin-B1 and nephrin clearly decreased in kidney when proteinuria peaked and that the remaining Ephrin-B1 and nephrin were dissociated. In other words, the person would have confirmed whether the presence or lack of the Ephrin-B is released to the urine sample because kidney releases protein in urine and Fukusumi teaches positive connection and correlation between Ephrin-B, proteinuria (protein in urine) and nephrotic syndrome.
Furthermore, it would have been obvious to have used the anti-Ephrin-B1 antibody (Fig. 2) for detecting and correlating Ephrin-B1 with nephrotic syndrome as taught by Fukusumi in the urine sample as taught by Fehnel because Fukusumi teaches that Ephrin-B1 correlates with human patient having active nephrotic syndrome in kidney and Fehnel teaches measurement of urinary EphrinB2 demonstrates clinical relevance as a biomarker and levels of EphrinB2 in urine were quantified using ELISA assay and results were normalized to overall urinary protein concentration and compared to levels from control patients. Thus, it would have been obvious to the person would have measured and correlated urine samples (produced from the kidney) to determine whether the dissociated Ephrin-B1s are released by the kidney in urine sample for nephrotic syndrome patients. Because the kidney can be correlated with a clear decreased in Ephrin-B1 for nephrotic syndrome, it would have been obvious to have determined the released level of Ephrin-B1 in urine to correlate and diagnose the level of Ephrin-B1 against nephrotic syndrome patients. Additionally, it would have been obvious to have treated nephrotic syndrome of Fukusumi with an effective compound as taught by Nishi after comparing with control samples because both Fukusumi and Nishi recognize subjects with nephrotic syndrome are being treated.
The person would have a reasonable expectation of success in measuring Ephrin-B in urine sample through antibodies to diagnose nephrotic syndrome patients because it has been well recognized by Fehnel to quantitate Ephrin-B through antibody detection in urine samples.
With respect to claim 6, Fukusumi teaches dual labeling of immunofluorescence images of Ephrine-B1 (green) and nephrin (red) (see Fig. 7 and pg. 1471, right col., para. 2), would read on a diagnostic reagent having a labeling reagent.
With respect to claims 8-9, Fukusumi teaches ephrin-B1 (see abstract).
With respect to claims 10-11, Fukusumi teaches Western blot (see Fig. 7, caption).
With respect to claims 13-14, Fukusumi teaches EphB2 (see pg. 1463, right col., para. 2).
With respect to claim 16, Fukusumi does not explicitly teach calibration curves or confidence interval of Ephrin-B1 concentrations in urine without nephrotic syndrome. Fehnel teaches receiver operating characteristic (ROC) curve analysis was applied to assess the predictive accuracy of the biomarkers with area under the curve (AUC) and 95% confidence intervals (see pg. 661, left col., para. 2). Fehnel teaches normal controls (see pg. 667, right col. para. 1). Fig. 5 shows control sample are compared. Fehnel teaches demographics and Ephrin-B2 levels with controls and Ephrin-B3 is elevated in the urine of patients compared to controls, sensitivity, and overall accuracy (see Table 2 and pg. 665). Thus, it would have been obvious to have produced statistical analysis with generated calibration curve between patients with control standard patients for determining sensitivity and accuracy, as taught by Fehnel.
With respect to claim 17, Fukusumi teaches compared with controls, ephrin-B1 conditional knockout mice displayed altered podocyte morphology, disarrangement of the slit diaphragm molecules and proteinuria. As stated above, Fukusumi does not teach detecting ephrin-B1 in urine sample. Fehnel teaches detecting ephrin-B1 in urine sample. Thus, it would have been obvious to have detected ephrin-B1 in urine to enable early detection of nephrotic syndrome because Fukusumi teaches a correlation in ephrin-B1 levels and nephrotic syndrome.
With respect to claim 19, Fukusumi teaches human kidney specimens (see pg. 1463, right col., last para.).
Claims 12, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fukusumi et al., Nishi et al. and Fehnel et al., as applied to claim 3 above, and further in view of Ghayur et al. (WO2009/134776A3, published 11/05/2009).
Fukusumi, Nishi, and Fehnel do not teach monoclonal antibody (claim 12), comparing the assay signal to a calibration curve generated using reference standards containing known concentrations of Ephrin-B1 (claim 15) and monitoring disease progression or remission by repeating steps (i)-(iii) at a later time point and comparing the determined concentration of Ephrin-B 1 to a previously determined concentration obtained from an earlier performance of steps (i)-(iii) (claim 18).
Ghayur teaches monoclonal antibodies are highly specific, being directed against a single antigen (see pg. 74, lines 30-35). Ghayur teaches establishing calibration (standard) curves for interpolation of the concentration of an analyte such as an antibody or an analyte and a single calibrator which is near a predetermined positive/negative cutoff (see pg. 85, lines 32-37). Ghayur teaches a predetermined level as employed for monitoring disease progression and/or treatment, the amount or concentration of analyte (see pg. 181, lines 33-36). Ghayur teaches optimally the method comprises the steps of determining the concentration or amount in a test sample from a subject of analyte and determining the concentration or amount in a later test sample from the subject of analyte and comparing the concentrations (see pg. 183, lines 5-10). Ghayur teaches test sample such as urine (see pg. 186, lines 22-27).
Thus, it would have been obvious to have modified the detection of Ephrin-B in urine with monoclonal antibodies, calibration curves, and monitoring the progression of Ghayur and with a reasonable expectation of success because Ghayur teaches these elements provide sensitivity and optimal detection for antibodies in samples such as urine.
Response to Arguments
Applicant's arguments filed 05/08/2026 have been fully considered but they are not persuasive under 35 U.S.C. 101 and 103 rejections
With respect to the 35 U.S.C. 101 rejection, Applicant argues page 7, para. 2, that the USPTO Eligibility Example 29 that claims that required laboratory detection using specific non-conventional antibodies and applied the results in a defined diagnostic process were found eligible.
The arguments are not found persuasive because antibodies and Eph receptor (naturally produced) are not unconventional methods for detecting Ephrin-B1. The are simply conventional methods used for data gathering. As stated above, these limitations constitute to insignificant extra-solution activity (e.g., a mere data gathering step necessary to use the correlation). Detecting whether the intended biomarker is present in urine sample merely instructs a practitioner to use any immunoassay detection with generic antibodies for Ephrin-B and naturally produced Eph receptor. When so evaluated, this additional element represents mere for data gathering (obtaining information) that is necessary for use of the recited judicial exception and is recited at a high level of generality. There is no meaningful limitation such as a particular or unconventional element for data gathering.
With respect to the 35 U.S.C. 103 rejection, Applicant argues, page 10, that Ephrin-B1 expression in kidney tissue decreases as proteinuria increases, reflecting downregulation or structural dissociation at the slit diaphragm. In contrast Fehnel teaches that in a different disease-pediatric cerebral arteriovenous malformations (CVM)-Ephrin-B2 expression increases in tissue and this increase correlates with elevated urinary levels. Applicant argues that rather than motivating one skilled in the art to combine the references, Fukusumi teaches away from the expectation that Ephrin-B1 would appear in urine at elevated levels to determine concentrations in nephrotic syndrome. Second, Applicant argues that the rejection relies on an unsupported assumption that loss of Ephrin-B1 from kidney tissue in Fukusumi would necessarily result in detectable Ephrin-B1 in urine. Third, there is no reasonable expectation of success in extrapolating Fehnel’s urinary detection results to nephrotic syndrome nor Nishi’s method.
The arguments are not found persuasive because as understood by Fukusumi that proteinuria increases. Fukusumi establishes a urinary protein/creatinine analysis (see Fig. 1), which indicates that there is an increase in proteins development in urine sample while a decrease of Ephrin-B1 in kidney tissue due to structural dissociation. Meanwhile, urine sample is filtered from kidney. The finding of structural dissociation resulted in a decrease of Ephrin-B1 in the kidney would conclude that dissociated Ephrin-B1 would be present in urine sample. Meanwhile, Fehnel discloses that Ephrin-B is present in urine and can be detected through antibody detection. Therefore, it would have been obvious to see whether the dissociated Ephrin-B is present in urine, as urinary protein/creatinine increases. Because Fukusumi has already disclosed a correlation between Ephrin-B1 and nephrotic syndrome, there would be a reasonable expectation of success without hindsight in measuring urine samples.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) 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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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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