DETAILED ACTION
Applicant’s response filed 10/29/2025 has been fully considered. The following rejections and/or objections are either reiterated or newly applied.
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 .
Status of the Claims
Claim 5 is pending and under consideration in this action. Claims 1-4 are withdrawn as being in nonelected groups in the reply filed 7/3/2025. Claims 6-11 were canceled in the amendment filed 10/29/2025.
Priority
The instant application is 371 of PCT/KR2020/002542, filed 02/21/2020, which claims priority to Republic of Korea Application Number 10-2019-0021461, filed 02/22/2019, as reflected in the filing receipt mailed on 10/25/2022. The claims to the benefit of priority are acknowledged and the effective filing date of claim 5 is 02/22/2019.
Specification
The objection to the specification to include the “Cross-reference to related applications" section is withdrawn in view of Applicant’s amendment to the specification filed 10/29/2025.
Claim Objections
The objections to claims 6 and 7 are withdrawn because Applicant has canceled these claims in the amendment filed 10/29/2025.
Withdrawn Rejections
35 U.S.C. 112(b)
The rejection of claims 6-11 under 35 U.S.C. 112(b) as being indefinite is withdrawn because Applicant has canceled these claims (Applicant’s Remarks, Pg. 6, “Claim Rejections – 35 U.S.C. 112(b)”).
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 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and a law of nature, without significantly more. The claim recites (1) mathematical concepts (mathematical relationships, formulas or equations, or mathematical calculations), (2) mental processes, i.e., concepts performed in the human mind (including observations, evaluations, judgements or opinions), and (3) a law of nature (naturally occurring principles/relations) (see MPEP § 2106.04(a) and MPEP § 2106.04(b)).
Any newly recited portions herein are necessitated by claim amendment.
Step 1:
In the instant application, claim 5 is directed towards method, which falls into one of the categories of statutory subject matter (Step 1: YES).
Step 2A, Prong One:
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon (Step 2A, Prong One). The following instant claim recites limitations that equate to one or more categories of judicial exceptions:
Claim 5 recites a mathematical calculation in “converting the GC/TOF MS analysis result into a numerical value capable of being statistically processed by dividing a total analysis time by unit time intervals”; a mental process (i.e., an evaluation of the largest peak) in “determining a largest one of an area or height of chromatogram peaks displayed during the unit time as a representative value for the unit time”; a mathematical concept (i.e., performing a statistical analysis of the biomarkers) in “statistically verifying discrimination between male and female groups using partial least squares discriminant analysis (PLS-DA) to identify metabolite biomarkers consisting of asparagine dihydrate, β-alanine, L-cysteine, lactate, and tyrosine, and stearic acid”; and a natural correlation / law of nature in “wherein a positive loading value of the PLS-DA indicates an increasing tendency of the metabolite biomarkers and a negative loading value indicates a decreasing tendency of the metabolite biomarkers”.
The limitations reciting mental processes or mathematical concepts are similar to the concepts of collecting information, and displaying certain results of the collection and analysis is Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)), and organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships.
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification, and are determined to be directed to mental processes that in the simplest embodiments are not too complex to practically perform in the human mind. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
The limitation reciting a law of nature is similar to the concept of a correlation that is the consequence of how a certain compound is metabolized by the body in Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012) that the courts have identified as a natural correlation / law of nature. The instant claims must therefore be examined further to determine whether they integrate the abstract idea and law of nature into a practical application (Step 2A, Prong One: YES).
Step 2A, Prong Two:
In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP § 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea or law of nature is integrated into a practical application (MPEP § 2106.04(d)(I)). If the claim contains no additional elements beyond the abstract idea or law of nature, the claim fails to integrate the abstract idea or law of nature into a practical application (MPEP § 2106.04(d)(III)). The following claim recites limitations that equate to additional elements:
Claim 5 recites “a metabolite sampling step that extracts metabolites from urine using a mixed solvent of formic acid and methanol at a volume ratio of 0.05-0.5:99.5-99.95 without urease treatment of the urine” and “analyzing the extracted metabolites by means of a gas chromatography/time-of-flight mass spectrometry (GC/TOF MS) analyzer”.
Regarding the above cited limitations in claim 5 of (i) a metabolite sampling step that extracts metabolites from urine using a mixed solvent of formic acid and methanol at a volume ratio of 0.05-0.5:99.5-99.95 without urease treatment of the urine; and (ii) analyzing the extracted metabolites by means of a gas chromatography/time-of-flight mass spectrometry (GC/TOF MS) analyzer. These limitations equate to insignificant, extra-solution activity of mere data gathering because these limitations gather data before or after the recited judicial exceptions of statistically verifying discrimination between male and female groups using partial least squares discriminant analysis (PLS-DA) to identify metabolite biomarkers (see MPEP § 2106.04(d)). As such, claim 5 is directed to an abstract idea and a law of nature (Step 2A, Prong Two: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to well-understood, routine and conventional (WURC) limitations (MPEP § 2106.05(d)). The instant claims recite same additional elements described in Step 2A, Prong Two above.
Regarding the above cited limitations in claim 5 of (i) a metabolite sampling step that extracts metabolites from urine using a mixed solvent of formic acid and methanol at a volume ratio of 0.05-0.5:99.5-99.95 without urease treatment of the urine; and (ii) analyzing the extracted metabolites by means of a gas chromatography/time-of-flight mass spectrometry (GC/TOF MS) analyzer. These limitations are considered to be insignificant extra-solution activity of mere data gathering. These steps are incidental to the primary process of statistically verifying discrimination between male and female groups using partial least squares discriminant analysis (PLS-DA) to identify metabolite biomarkers, wherein the extracted numerical value from the GC/TOF MS analysis is merely an input for the statistical analysis using PLS-DA (see MPEP § 2106.05(g)).
Additionally, regarding the above cited limitations in claim 5 of (i) a metabolite sampling step that extracts metabolites from urine using a mixed solvent of formic acid and methanol at a volume ratio of 0.05-0.5:99.5-99.95 without urease treatment of the urine; and (ii) analyzing the extracted metabolites by means of a gas chromatography/time-of-flight mass spectrometry (GC/TOF MS) analyzer. These limitations when viewed individually and in combination, are WURC limitations as taught by Ming et al. (A rapid and accurate UPLC/MS/MS method for the determination of benzodiazepines in human urine. J Chromatogr B Analyt Technol Biomed Life Sci. 879(5-6): 421-428 (2011); newly recited) and Fan et al. (Sex-associated differences in baseline urinary metabolites of healthy adults. Scientific Reports 8: 11883 (2018); previously cited). Ming et al. discloses the sample preparation and extraction of patient urine samples. Methanol (containing 0.2% formic acid) was used for the extraction and protein precipitation without urease treatment (limitation (i)) (Pg. 423, Col. 2, Para. 2). Fan et al. discloses a method of analyzing sex-associated differences in baseline urinary metabolites using GC-TOF-MS (limitation (ii)) (Title, and Pg. 2, Para. 7).
These additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the instant claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claim 5 is not patent eligible.
Response to Arguments under 35 U.S.C. 101
Applicant’s arguments filed 10/29/2025 have been fully considered but they are not persuasive.
Applicant argues that the present invention clearly recognizes the problem that conventional standardized urine metabolite extraction methods include urease treatment for urea removal. Based on this problem recognition, the present invention proposes an extraction method without urease treatment to prevent metabolite changes and extract them in their original state with high reproducibility. This is fundamentally different from Ahn et al. simply not using urease. The unexpected result detailed by Applicant shows that the urease-free extraction method is not merely a "choice" but significantly influences the metabolite profile, and the result was unpredictable from the prior art. Ahn et al. neither reported this change nor attempted to solve the resulting reduction in biomarker discovery ability. (Applicant’s remarks, Pg. 7-8, “1. Recognition of Technical Problem and Novel Solution”). Applicant’s arguments are not persuasive for the following reasons:
In the newly recited portion of the rejection, the metabolite extraction step has been identified as an additional element in Step 2A, Prong Two, as detailed above. Further analysis at Step 2B shows that the extraction step, with the specific formic acid/methanol ratio, is a WURC limitation as taught by Ming et al. Ming et al. further discloses that in comparison with previously reported methods, the extraction protocol was optimized to simplify the sample extraction process (Ming et al., Pg. 421, Col. 2, Para. 2). Therefore, the unexpected results detailed by Applicant are not unpredictable in comparison to Ming et al. This argument is thus not persuasive.
Applicant argues that the present invention selected the optimal solvent (formic acid:methanol mixture) based on extraction efficiency, reproducibility, and protein precipitation rate. Ahn et al. only used pure methanol and made no attempt to optimize the extraction method through comparative analysis with other extraction solvents. Therefore, the metabolite sampling step of the present invention is not merely a WURC activity of collecting data, but rather a technical and concrete inventive concept that clearly recognizes and solves the problems of existing methods, and its effect is experimentally proven. This satisfies the requirement of integrating the abstract idea into a practical application. (Applicant’s remarks, Pg. 8, “2. Systematic Optimization of Extraction Solvent”). Applicant’s arguments are not persuasive for the following reasons:
As described in Step 2B and the arguments directly above, the extraction step with the optimized formic acid/methanol ratio is a WURC limitation as taught by Ming et al. Not only does Ming et al. disclose the appropriate ratio (0.2:99.8% formic acid:methanol), but also discloses that the extraction protocol was optimized to simplify the sample extraction process (Ming et al., Pg. 421, Col. 2, Para. 2). Therefore, the extraction step is a WURC limitation as taught by Ming et al., and does not integrate the abstract idea into a practical application. This argument is thus not persuasive.
Applicant argues that the proposed amended claim 5 limits the use of a specific solvent and its volume ratio, making the "metabolite sampling step" not merely a conventional data collection activity, but a specific and non-conventional technical application that maximizes the inventive effect. This is a critical technical advancement that improves data quality and reliability, and includes a practical application that places a 'meaningful limit' on the abstract idea. (Applicant’s remarks, Pg. 9, “3. Providing Significantly More”). Applicant’s arguments are not persuasive for the following reasons:
As described in Step 2B and the arguments directly above, the extraction step with the optimized formic acid/methanol ratio is a WURC limitation as taught by Ming et al. The optimized solvent extraction method in amended claim 5 has been disclosed in the prior art, and is therefore a WURC limitation as taught by Ming et al. Since the extraction step is a WURC limitation, it does not provide significantly more than the abstract idea, and does not integrate the judicial exceptions into patent-eligible practical application. This argument is thus not persuasive.
Claim Rejections - 35 USC § 103
Withdrawn Rejections
The rejection of claims 5-9 and 11 under 35 U.S.C. 103 as being unpatentable over Fan et al. in view of Ahn et al. is withdrawn in view of Applicant’s amendments to the claims filed 10/29/2025.
The rejection of claim 10 under 35 U.S.C. 103 as being unpatentable over Fan et al. in view of Ahn et al., Bouatra et al., and Zheng et al. is withdrawn in view of Applicant’s amendments to the claims filed 10/29/2025.
Newly Recited Rejections
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fan et al. (Sex-associated differences in baseline urinary metabolites of healthy adults. Scientific Reports 8: 11883 (2018); published 08/08/2018; previously cited) in view of Ming et al. (A rapid and accurate UPLC/MS/MS method for the determination of benzodiazepines in human urine. J Chromatogr B Analyt Technol Biomed Life Sci. 879(5-6): 421-428 (2011); published 12/31/2010; newly recited), Zheng et al. (Identification of sex-specific urinary biomarkers for major depressive disorder by combined application of NMR- and GC-MS-based metabonomics. Transl. Psychiatry 6: e955 (2016); published 11/15/2016; previously cited), and De Paepe et al. (A validated multi-matrix platform for metabolomic fingerprinting of human urine, feces and plasma using ultra-high performance liquid-chromatography coupled to hybrid orbitrap high-resolution mass spectrometry. Anal Chim Acta. 1033: 108-118 (2018); published 8/29/2018; newly recited).
This rejection is newly recited and necessitated by claim amendment.
Regarding claim 5, Fan et al. teaches a method of identifying biologically meaningful baseline sex-related differences using urine samples in healthy males and females using metabolomics profiling and bioinformatics analysis (i.e., a method for analysis of metabolite differentiation in urine samples to discriminate gender) (Abstract). Fan et al. further teaches that the metabolite profiles of the individual urine samples were investigated via gas-chromatography/mass-spectrometry (GC-MS) analysis. The Gerstel CIS4–with dual MPS Injector and Agilent 6890 GC-Pegasus III TOF MS was used for this analysis (i.e., analyzing the extracted metabolites by means of a gas chromatography/time-of-flight mass spectrometry (GC/TOF MS) analyzer) (Pg. 2, Para. 7). Fan et al. further teaches the annotation and identification of the compounds using the following method. The peak and compounds detection or deconvolution was performed with the Leco ChromaTOF software. Spectra were matched against the FiehnLib Mass Spectral and Retention Index Library. Post-curation and peak replacements were performed with the in-house developed BinBase software and the sample matrix with all known and unknown compounds was exported to an excel sheet. Missing peak intensity data was automatically replaced with the raw extracted ion intensities at the target retention times for each compound, subtracted by adjacent noise levels. This way, only 2 of the 49,680 values were reported with ‘zero’ values, compound BB 109708 and creatinine. These two values were replaced with a value of 1 (i.e., converting the GC/TOF MS analysis result into a numerical value capable of being statistically processed) (Pg. 3, Para. 3). Fan et al. further teaches that for each chromatogram and each missing value, the intensity of the quantification ion at this retention time was extracted by seeking its maximum value in a retention time region of 1 sec and subtracting the minimum (local background) intensity in a retention time region of 5 sec around the peak maximum (i.e., dividing a total analysis time by unit time intervals and determining a largest one of an area or height of chromatogram peaks displayed during the unit time as a representative value for the unit time) (Pg. 4, Para. 1). Fan et al. further teaches that multivariate statistical analyses, principal component analysis (PCA), and partial least-square discriminant analysis (PLS-DA), were performed to discriminate males and females (Pg. 5, Para. 1). Fan et al further teaches that the Mann-Whitney U test was performed on each compound to compare males vs. females. The Benjamini-Hochberg false discovery rate (FDR) correction was utilized to deal with the multiple comparison problem (i.e., statistically verifying discrimination between male and female groups using partial least squares discriminant analysis (PLS-DA) to identify metabolite biomarkers) (Pg. 6, Para. 1). Fan et al. further teaches that the all metabolites screened and identified in the study are shown in Supplementary Table 2, which include β-alanine, stearic acid, and tyrosine (i.e., metabolite biomarkers consisting of beta-alanine, tyrosine, and stearic acid) (Pg. 7, Para. 2; Pg. 4, Fig. 2; and Supplementary Table 2, Pg. 1 and 3).
Fan et al. does not teach a metabolite sampling step that extracts metabolites from urine using a mixed solvent of formic acid and methanol at a volume ratio of 0.05-0.5:99.5-99.95 without urease treatment of the urine; metabolite biomarkers consisting of asparagine dihydrate, L-cysteine, and lactate; and wherein a positive loading value of the PLS-DA indicates an increasing tendency of the metabolite biomarkers and a negative loading value indicates a decreasing tendency of the metabolite biomarkers.
Regarding claim 5, Ming et al. teaches the sample preparation and extraction of patient urine samples. Methanol (containing 0.2% formic acid) was used for the extraction and protein precipitation. First, 1mL of methanol–0.2% formic acid solution was added into each patient urine, standard curve, and QC sample. Then all samples were vortex mixed for 30s, and after that, were centrifuged at 13,000 rpm (18°C) for 10 min (i.e., a metabolite sampling step that extracts metabolites from urine using a mixed solvent of formic acid and methanol at a volume ratio of 0.05-0.5:99.5-99.95 without urease treatment of the urine) (Pg. 423, Col. 2, Para. 2).
Regarding claim 5, Zheng et al. teaches the differences and similarities of urinary metabolites in men and women including lactate and cysteine (i.e., metabolite biomarkers consisting of lactate and L-cysteine) (Pg. 4, Fig. 2). Zheng et al. further teaches the OPLS-DA score plots displaying discrimination between women and men patients from their respective healthy controls (HCs). The plots show several markers (in blue) that have a positive loading value (t[1]P) in men and women, as well as a few markers that have a negative loading value (t[1]P) (Pg. 3, Fig. 1). Zheng et al. further teaches that by analyzing the OPLS-DA loading coefficient plot, they identified 27 differential metabolites that distinguished women patients from women HCs. Compared with HCs, women patients were characterized by higher levels of lactate and other markers, as well as lower levels of tyrosine, and other markers. Furthermore, they identified 36 differential metabolites that distinguished men patients from men HCs. Compared with HC, men patients were characterized by higher levels of 12 metabolites and lower levels of 24 metabolites (i.e., wherein a positive loading value of the PLS-DA indicates an increasing tendency of the metabolite biomarkers and a negative loading value indicates a decreasing tendency of the metabolite biomarkers) (Pg. 2, Col. 2, Para. 4 – Pg. 3, Col. 1, Para. 1).
Regarding claim 5, De Paepe et al. teaches a heat map of identified metabolites that were evaluated in light of the gender-specific metabolic shifts. The heat map includes L-asparagine (i.e., metabolite biomarkers consisting of asparagine dihydrate) (Pg. 115, Fig. 3).
An invention would have been prima facie obvious to one or ordinary skill in the art before the effective filing date of the claimed invention if some teaching, suggestion or motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. Fan et al. discloses a method to identify biologically meaningful baseline sex-related differences using urinary metabolomics via GC/TOF-MS and bioinformatics analysis (Fan et al., Abstract and Pg. 2, Para. 3). Ming et al. discloses a method for extraction and analysis of benzodiazepines in urine (Ming et al., Title and Abstract). Zheng et al. discloses a method to investigate sex differences of urinary metabolite markers in major depressive disorder compared to healthy controls using GC-MS (Zheng et al., Abstract). De Paepe et al. discloses a platform for metabolomic fingerprinting for urine capable of discriminating according to gender (De Paepe et al., Title and Abstract).
Therefore, one of ordinary skill in the art would have been motivated to combine the method of analyzing urinary metabolites to discriminate gender shown by Fan et al. with the extraction method of Ming et al. because the extraction method of Ming et al. simplified the sample extraction protocol (Ming et al. Pg. 421, Col. 2, Para. 2). One of ordinary skill in the art would be able to combine the teachings of Fan et al. and Ming et al. with reasonable expectation of success due to the same nature of the problem to be solved, since both are drawn towards a method for extracting compounds from urine.
One of ordinary skill in the art would have also been motivated to combine the method of analyzing urinary metabolites to discriminate gender shown by Fan et al. with the metabolite identification and analysis of Zheng et al. because the identified urinary metabolic signatures for differentiating men and women with major depressive disorder may aid in the identification of sex-specific urine-based diagnostic and prognostic tests (Zheng et al., Pg. 6, Col. 2, Para. 1). One of ordinary skill in the art would be able to combine the teachings of Fan et al. and Zheng et al. with reasonable expectation of success due to the same nature of the problem to be solved, since both are drawn toward a method for identifying sex-specific biomarkers using GC-MS.
One of ordinary skill in the art would have also been motivated to combine the method of analyzing urinary metabolites to discriminate gender shown by Fan et al. with the metabolites identified by De Paepe et al. because the urinary metabolome provides valuable insights into the metabolic and biological activities that precede the sampling moment, and are therefore well suited for depicting chronic illnesses (De Paepe et al., Pg. 109, Col. 2, Para. 1). One of ordinary skill in the art would be able to combine the teachings of Fan et al. and De Paepe et al. with reasonable expectation of success due to the same nature of the problem to be solved, since both are drawn toward a method for identifying sex-specific biomarkers.
Therefore, regarding claim 5, the instant invention is prima facie obvious (MPEP § 2142).
Response to Arguments under 35 U.S.C. 103
Applicant’s arguments filed 10/29/2025 have been fully considered but they are not persuasive.
Applicant argues that Ahn et al. and Fan et al. do not disclose or suggest the use the extraction protocol in amended claim 5 of “a mixed solvent of formic acid and methanol at a specific volume ratio (0.05-0.5:99.5-99.95)” (Applicant’s Remarks, Pg. 10, “Clear Differentiation from Prior Art”). Applicant’s arguments are not persuasive for the following reasons:
Applicant’s arguments regarding Ahn et al. and Fan et al. not teaching the extraction protocol in amended claim 5 have been considered but they are not persuasive in view of the new grounds of rejection that relies on a new combination of references as necessitated by claim amendment. In the new grounds of rejection described above, the extraction step is taught by Ming et al., disclosing an extraction protocol using methanol containing 0.2% formic acid without urease treatment. This extraction ratio falls within the specified range in the amended claim, and thus, this argument is not persuasive.
Applicant argues that the present invention does not merely use known solvents, but provides a nonobvious optimized extraction method that achieves superior technical effects (enhanced extraction efficiency, reproducibility, and protein precipitation capability) through optimized conditions, which are neither disclosed nor suggested by the prior art. (Applicant’s Remarks, Pg. 10, “Inventive Concept & Unexpected Results”). Applicant’s arguments are not persuasive for the following reasons:
In the new grounds of rejection described above, the extraction step is taught by Ming et al., using methanol containing 0.2% formic acid. This solvent combination was used for extraction and protein precipitation (Ming et al., Pg. 423, Col. 2, Para. 2). In comparison with previously reported methods, the extraction protocol of Ming et al. was optimized to simplify the sample extraction process (Ming et al., Pg. 421, Col. 2, Para. 2). Therefore, Ming et al. does not merely use known solvents, and optimized the extraction process described therein. This argument is thus not persuasive.
Conclusion
No claims 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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/D.P.S./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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