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 .
Summary
Claims 1, 3-8, 11, and 14-19 are pending. Claims 1, 3-8, 11, and 14-19 are rejected herein. This is a Final Rejection as necessitated by the amendment and arguments (hereinafter “the Response”) dated 20 Aug 2026.
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.
Claim(s) 1, 3, 5-8, and 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over GONCALVES et al. (Carlos Gonçalves, Carsten Mischke & Joerg Stroka (2020) Determination of deoxynivalenol and its major conjugates in cereals using an organic solvent-free extraction and IAC clean-up coupled in-line with HPLC-PCD-FLD, Food Additives & Contaminants: Part A, 37:10, 1765-1776, DOI: 10.1080/19440049.2020.1800829) in view of CHEN et al. (US 20210293813).
Regarding claim 1: GONCALVES discloses: A method of eluting a bound analyte (the mycotoxin deoynivalenol [DON] in abstract) from an immunoaffinity column (IAC; abstract), the method comprising: passing a sample solution comprising an analyte of interest (various concentrations of DON in solution on page 1767 section “materials and reagents”) through the immunoaffinity column (“percolated quantitatively through the IACs” on page 1767 col. 2 para. 1) to associate a portion of the analyte of interest (DON) to stationary phase material of the immunoaffinity column (This is the purpose of an IAC); heating the immunoaffinity column at a temperature between 65° C. to 95° C (85 ° C on page 1768 col. 1 step i). for a time period between 1 minute and 30 minutes (5 minutes on page 1768 col. 1 step i) to disassociate the portion of the analyte of interest from the stationary phase material; and rinsing the immunoaffinity column with a buffer (Milli Q water on page 1768 step iii) to create an eluate including the disassociated portion of the analyte of interest (which is moved to an HPLC injection loop in step (iii) in col. 1 of page 1768); and applying the eluate directly into the downstream processing system without modification of eluate (Eluate is transferred directly into the injection loop of the HPLC apparatus as discussed is step (ii) in col. 1 on page 1768.).
GONCALVES does not disclose using a lateral flow strip for the analysis.
CHEN however does teach that using lateral flow strips is a known analysis technique for use after mycotoxin concentration using IACs (para. 4).
One skilled in the art at the time the application was effectively filed would be motivated to use a lateral flow strip as taught by CHEN to analyze the output of the IAC of GONCALVES because they are rapid tests (para. 4-5 of CHEN), and therefore will produce results quickly. Please note that CHEN teaches performing buffer exchange but only as an optional technique (“if needed” in para. 19; “if necessary” in para. 41), The method of CHEN as set forth in their specification and claim 1, teaches applying the eluate directly to downstream processing without buffer exchange.)
Regarding claim 3: GONCALVES discloses: the solution for rinsing the immunoaffinity column is an aqueous solution (Milli Q water in step (i) in col. 1 of page 1768).
Regarding claim 5: GONCALVES discloses that the column is heated to 85° C in step (i) in col. 1 of page 1768. Therefore GONCALVES does not specify exactly 90° C. Nonetheless, the skilled artisan would know too that the temperature of the column would determine how efficiently the analyte is dissociated from the column (page 1768 col. 2 last para. to page 1769 col. 1 first para.).
The specific claimed temperature, absent any criticality, is only considered to be the “optimum” temperature disclosed by GONCALVES that a person having ordinary skill in the art would have been able to determine using routine experimentation (see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)) based, among other things, on the desired cycle time, the material in the IAC, the analyte of interest, manufacturing costs, etc. (see In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and neither non-obvious nor unexpected results, i.e. results which are different in kind and not in degree from the results of the prior art, will be obtained as long as the temperature is used, as already suggested by GONCALVES.
Since the applicant has not established the criticality (see next paragraph) of the temperature stated and since these temperatures are in common use in similar devices in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to use these values in the device of GONCALVES.
Please note that the specification contains no disclosure of either the critical nature of the claimed temperature or any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the applicant must show that the chosen dimensions are critical. In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 6 and 7: GONCALVES teaches most aspects of the instant invention. GONCALVES discloses that “hot water elution is an efficient and convenient strategy, but the IACs must be kept at a sufficiently high temperature for the shortest period of time that enables a quantitative elution of the analytes without their degradation (page 1769 para. 1). For the particular column and analyte used in their trials, GONCALVES found this time to be 5 minutes. Therefore, GONCALVES does not explicitly teach holding the temperature for 7 minutes or 10 minutes. Nonetheless, the skilled artisan would know too that the time for which the column is held at the elevated temperature determines how efficient and complete the analyte desorption from the IAC is (page 1768 last para. of GONCALVES).
The specific claimed time, absent any criticality, is only considered to be the “optimum” time disclosed by GONCALVES that a person having ordinary skill in the art would have been able to determine using routine experimentation (see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)) based, among other things, the analyte being desorbed, the material in the IAC doing the adsorbing, etc. (see In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and neither non-obvious nor unexpected results, i.e. results which are different in kind and not in degree from the results of the prior art, will be obtained as long as the time is used, as already suggested by GONCALVES. Please note that neither the analyte nor the adsorption material of the IAC are specified for claims 6 and 7.
Since the applicant has not established the criticality (see next paragraph) of the time stated and since these times are in common use in similar devices in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to use these values in the device of GONCALVES.
Please note that the specification contains no disclosure of either the critical nature of the claimed time or any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the applicant must show that the chosen dimensions are critical. In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 8: GONCALVES discloses: the column is held at temperature for 5 minutes (step (i) in col. 1 of page 1768).
Regarding claim 14: GONCALVES discloses: the sample solution includes a powdered food sample mixed with water (The samples are milled wheat, barely, and maize added to water in sample preparation section on page 1767.)
Regarding claim 15: GONCALVES discloses: the sample solution includes a powdered food sample mixed with an organic solvent (The samples are milled wheat, barely, and maize added to water in sample preparation section on page 1767.).
Regarding claims 16 and 17: GONCALVES discloses: the sample solution is filtered prior to passing the sample solution through the immunoaffinity column (“the samples were centrifuged…and filtered through folded filter paper” in sample preparation section on page 1767).
Regarding claim 18: GONCALVES discloses: the immunoaffinity column is a mycotoxin immunoaffinity column (DON is a mycotoxin. Abstract; page 1768 col. 1 step i).
Regarding claim 19: GONCALVES discloses: the mycotoxin immunoaffinity column is an Ochratoxin immunoaffinity column (The material used to adsorb the DON, agarose gel [page 1769 col. 1 para. 1], also adsorbs Ochratoxin.).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over GONCALVES and CHEN in view of TANGNI et al. (US 20060263410).
Regarding claim 4: GONCALVES does not disclose conditioning the column.
TANGNI however does teach conditioning an immunoaffinity column with phosphate buffered saline (PBS) solution (para. 114).
One skilled in the art at the time the application was effectively filed would be motivated to condition the immunoaffinity column of CONCALVES with PBS as taught by TANGNI because it flushes out impurities before the analyte adsorption begins.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over GONCALVES and CHEN in view of OZALP et al. (US 20160299136).
Regarding claim 11: GONCALVES as modified by CHEN does not teach using a reader to determine a ratio of peak height of a test line to peak height of a control line.
OZALP however teaches using a reader (para. 9) on a lateral flow strip (para. 16) and determining a ratio of the test line to the control line (para. 54). Please note that OZALP teaches that his invention can be used in the detection of toxins (para. 60).
One skilled in the art at the time the application was effectively filed would be motivated to use an automated reader to speed up analysis time and eliminate the subjectivity of human judgement. Please note that OZALP teaches reading the test results by eye or using a reader (para. 9)
Response to Amendment/Arguments
The replacement drawings are acknowledged and the previous objections thereto are accordingly withdrawn.
The amendments to the claims to overcome the previous rejections under 35 U.S.C. 112 are acknowledged and said rejections are accordingly withdrawn.
The Applicant has argued (page 8 of the Response) that GONCALVES does not disclose that the eluate is applied “directly to the lateral flow device without buffer exchange of the eluate.” The Examiner agrees with this statement because in the non-final rejection, as well as in the present office action, CHEN is relied upon to teach the limitation of using a lateral flow device. Therefore this appears to be a piecemeal analysis of the rejection of claim 10. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Applicant has argued (page 9 of the Response) that CHEN does not teach use of a heat denaturing or elution with a buffer solution, from and IAC column, and adding the eluate directly to the lateral flow device. The Examiner agrees with this statement because in the non-final rejection and the present office action, GONCALVES is relied upon to disclose heat denaturing and elution with a buffer that is added directly to the analysis apparatus. Therefore this appears to be a piecemeal analysis of the rejection of claim 10. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Please note neither CHEN nor GONCALVES requires buffer exchange before analysis. Buffer exchange is discussed in para. 12, 19, and 41 of CHEN and is described as optional.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHANIEL J KOLB whose telephone number is (571)270-7601. The examiner can normally be reached M-F 9-5 EST.
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/NATHANIEL J KOLB/Examiner, Art Unit 2855
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