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 .
This office action is in response to amendments filed on January 28, 2026.
Claims 2 and 14 have been amended.
Claims 2-21 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11500528B2. Although the claims at issue are not identical, they are not patentably distinct from each other. An exemplary mapping of pending claim 2 and claim 1 of U.S. Patent No. 11500528B2 is presented below; similar mappings apply to pending claims 3-21 and 2-19 of U.S. Patent No. 11500528B2.
Regarding claim 2, U.S. Patent No. 11500528B2 discloses a computer-implemented method for determining first and second sets of matching test items using one or more sensors, the method comprising:
obtaining, using the one or more sensors, a first set of test results indicative of interactions between a first target item and a plurality of test items (data sets obtained from one or more sensors)(claim 1);
transmitting the first set of test results to an analysis computer system (accessing a plurality of data sets each associated with a different target item and a plurality of test items)(claim 1; in order for sets of data to be access it must be transmitted);
identifying, using the analysis computer system, a first set of matching test items that interact with the first target item beyond a first threshold based on the first set of test results (identifying one or more matching test items that interact with each of the respective target items within the corresponding threshold parameter)(claim 1);
obtaining, using the one or more sensors, a second set of test results indicative of reactions between a second target item and the plurality of test items (data sets obtained from one or more sensors)(claim 1);;
transmitting the second set of test results to the analysis computer system (accessing a plurality of data sets each associated with a different target item and a plurality of test items)(claim 1; in order for sets of data to be access it must be transmitted);
identifying, using the analysis computer system, a second set of matching test items that interact with the second target item beyond a second threshold based on the second set of test results (identifying one or more matching test items that interact with each of the respective target items within the corresponding threshold parameter)(claim 1);
determining, based on the first and second sets of matching test items, a characteristic common to each of the first and second sets of matching test items (identifying a characteristic common to the matching test items in how each of the matching test items chemically interacts with the respective target items)(claim 1); and
based on the first and second sets of matching test items and on the characteristic, generating a new set of test results comprising a first portion of the first test results and a second portion of the second test results previously obtained using the one or more sensors (based on the matching test items and on the characteristic, generating, in conjunction with the one or more sensors, a new data set at the computing system)(claim 1; as the new data set is based on the matching test items they comprise a corresponding portion of data).
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11768595B2. Although the claims at issue are not identical, they are not patentably distinct from each other. An exemplary mapping of pending claim 2 and claim 1 of U.S. Patent No. 11768595B2is presented below; similar mappings apply to pending claims 3-21 and 2-20 of U.S. Patent No. 11768595B2.
Regarding claim 2, U.S. Patent No. 11768595B2 discloses a computer-implemented method for determining first and second sets of matching test items using one or more sensors, the method comprising:
obtaining, using the one or more sensors, a first set of test results indicative of interactions between a first target item and a plurality of test items (data sets obtained from one or more sensors)(claim 1);
transmitting the first set of test results to an analysis computer system (receiving one or more data sets each associated with a different target item and a plurality of test items)(claim 1; in order for sets of data to be received it must be transmitted);
identifying, using the analysis computer system, a first set of matching test items that interact with the first target item beyond a first threshold based on the first set of test results (identifying one or more matching test items that interact with each of the respective target items within the corresponding threshold parameter)(claim 1);
obtaining, using the one or more sensors, a second set of test results indicative of reactions between a second target item and the plurality of test items (data sets obtained from one or more sensors)(claim 1);;
transmitting the second set of test results to the analysis computer system (receiving one or more data sets each associated with a different target item and a plurality of test items)(claim 1; in order for sets of data to be received it must be transmitted);
identifying, using the analysis computer system, a second set of matching test items that interact with the second target item beyond a second threshold based on the second set of test results (identifying one or more matching test items that interact with each of the respective target items within the corresponding threshold parameter)(claim 1);
determining, based on the first and second sets of matching test items, a characteristic common to each of the first and second sets of matching test items (identifying, based on the filter selection, a characteristic common to the matching test items in how each of the matching test items interacts with the respective target items)(claim 1); and
based on the first and second sets of matching test items and on the characteristic, generating a new set of test results comprising a first portion of the first test results and a second portion of the second test results previously obtained using the one or more sensors (based on the matching test items and on the characteristic, generating, in conjunction with the one or more sensors, a new data set at a computing system)(claim 1; as the new data set is based on the matching test items they comprise a corresponding portion of data).
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.
Claims 2-3, 6-7, 9-11, 13-15, 18-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lamont et al. (US Publication 20070238181A1) in further view of Zhu et al. (US Publication 20050022168A1, Wouters et al. (US Publication 20030078738A1), and Yoshikawa et al. (US20180190386A1).
Regarding claim 2, Lamont teaches a computer-implemented method for determining first and second sets of matching test items using one or more sensors, the method comprising:
obtaining, using the one or more sensors, a first set of test results indicative of interactions between a first target item and a plurality of test items (a laboratory technician or Test System operator may perform the initial testing of samples using an appropriate panel (group of tests) ... raw test data can be obtained ... from an imaging sensor ... from one or more discrete sensors)([0025] and [0045]; a plurality targets (i.e., samples) are tested, including a first sample);
transmitting the first set of test results to an analysis computer system (The apparatus shown in FIG. 1 comprises a biochip test system 1 ... This system is used to carry out a number of different tests on a sample ... then stored in a store 2 ... A processor 3 is connected to the store 2 ... The processor carries out computations)([0031] and [0033]; first sample results are transmitted to a processer for processing);
identifying, using the analysis computer system, a first set of matching test items that interact with the first target item beyond a first threshold based on the first set of test results (the processor 3 accesses the relevant RLU values ... converts the RLU values into concentration data for each analyte (step 20) ... data may be presented as quantitative values and/or ... a cut-off concentration selected by the user)([0040]; processing compares first results to a threshold (i.e., cut off) for presentation);
obtaining, using the one or more sensors, a second set of test results indicative of reactions between a second target item and the plurality of test items (a laboratory technician or Test System operator may perform the initial testing of samples using an appropriate panel (group of tests) ... raw test data can be obtained ... from an imaging sensor ... from one or more discrete sensors)([0025] and [0045]; a plurality samples are tested, including a second sample);
transmitting the second set of test results to the analysis computer system (The apparatus shown in FIG. 1 comprises a biochip test system 1 ... This system is used to carry out a number of different tests on a sample ... then stored in a store 2 ... A processor 3 is connected to the store 2 ... The processor carries out computations)([0031] and [0033]; second sample results are transmitted to a processer for processing);
identifying, using the analysis computer system, a second set of matching test items that interact with the second target item beyond a second threshold based on the second set of test results (the processor 3 accesses the relevant RLU values ... converts the RLU values into concentration data for each analyte (step 20) ... data may be presented as quantitative values and/or ... a cut-off concentration selected by the user)([0040]; processing compares second results to a cut off for presentation).
Lamont differs from the claim in that Lamont fails to teach determining a characteristic common (i.e., classifying markers) of the matching test items (i.e., above a threshold). However, classifying markers of test items above a threshold is taught by Zhu (a thresholding procedure is carried out ... in which the absolute value of the test statistic exceeds a critical value (or threshold) determined ... A subset of k markers from the candidates determined ... certain markers may be correlated with stages of a condition or other individual traits ... only the more stable markers should be selected to derive the best k-subset of biomarkers)([0079], [0092], and [0100]). The examiner notes Lamont and Zhu teach a method for analyzing test data. As such, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lamont to include the classifying of Zhu such that the method determines a characteristic common of matching test items. One would be motivated to make such a combination to provide the advantage of discovering hidden patterns in datasets ([0015]; Zhu).
The combination of Lamont-Zhu fails to teach generating a new set of test results (i.e., retesting) based on the test items and characteristic (i.e., classification). However, retesting based on classification is taught by Wouters (Compounds with a predicted probability of being active of 10% or higher were suggested for retesting ... These false-negative candidates were then retested according to the original HTS protocol)([0123]). The examiner notes Lamont, Zhu, and Wouters teach a method for analyzing test data. As such, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lamont-Zhu to include the retesting of Wouters such that the method generating a new set of test results based on the test items and characteristic. One would be motivated to make such a combination to provide the advantage of improving detection of false positives and false negatives ([0028]; Wouters).
Although Lamont-Zhu-Wouters discloses of the new set of test results comprising a portion of test items (Wouters - This corresponds to the top 730 most probable compounds of the rank list ... FIG. 8 shows the % control profile of these 730 false-negative outlier candidates after retesting. In comparison to FIG. 7 which shows that the distribution of all compounds in the original experiment)([0123]; Figure 8 – new test results comprising a portion of test items (i.e., top 703 compounds) is shown). Lamont-Zhu-Wouters differs from the claim in that the portion consists of a first portion and a second portion of previously obtained test results. However, new set of test results consisting of a first portion and a second portion of previously obtained test results is taught by Yoshikawa (A compound experiment can further include one or more component experiments that “branch in” to or “branch out” of a base compound experiment ... Data collected at each component experiment can be used to adjust experimental parameters of any other component experiment, either automatically ... See the following example of a compound experiment ... Phase I ... 3) AnalyzePeaks=>analyze peaks generated in (2) and select fraction samples based on those peaks Phase II: Now take the fraction samples selected in (3) and perform the following four experiments in parallel ... 4) ExperimentHPLC (Analytical) 5) ExperimentPAGE … a particular consideration for parameter resolution is that the ExperimentHPLC experiment of step (4) can inherit many parameters from ExperimentHPLC run in step (2) … Phase III: Perform any one or more analysis ... upon the processing and analysis of the above steps, one or more of the following experiments can be performed ... 12) ExperimentAbsorbanceThermodynamics 13) ExperimentFluorescenceKinetics 14) ExperimentTransfection)([0106-0127]; new test results (e.g., output) contains portions of test results (i.e., data collected from previous experiments)). The examiner notes Lamont, Zhu, Wouters, and Yoshikawa teach a method for analyzing test data. As such, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lamont-Zhu-Wouters to include the comprising of Yoshikawa such that the method comprises new set of test results consisting of a first portion and a second portion of previously obtained test results. One would be motivated to make such a combination to provide the advantage of implementing an efficient, reliable, and scalable general framework for linking experiments together ([0004]; Yoshikawa).
Regarding claim 3, Lamont-Zhu-Wouters-Yoshikawa teach the computer-implemented method of claim 2, wherein the first set of test results are indicative of chemical interactions between the first target item and the plurality of test items (Lamont - A particularly important example is in the clinical analysis of samples, for example for drug testing)([0002]; drug testing involves chemical interactions between sample and test items).
Regarding claim 6, Lamont-Zhu-Wouters-Yoshikawa teach the computer-implemented method of claim 2, further comprising:
generating visualization data to display a graphical representation of at least one of the first or second sets of matching test items (Lamont - data may be presented as quantitative values and/or ... a cut-off concentration selected by the user. This information is displayed on the display 5)([0040]).
Regarding claim 7, Lamont-Zhu-Wouters-Yoshikawa teach the computer-implemented method of claim 6, wherein the visualization data are configured to depict information regarding the test items according to a measurement metric selected by a user (Lamont - a cut-off concentration selected by the user)([0040]; a cutoff value is a metric of measurement).
Regarding claim 9, Lamont-Zhu-Wouters-Yoshikawa teach the computer-implemented method of claim 2, wherein generating the new set of test results comprises exporting, based on the characteristic, at least one of the first or second sets of matching test items or the characteristic to a remote computing system in communication with the one or more sensors for producing the new set of test results (Wouters - these false-negative candidates were then retested according to the original HTS protocol)([0123]; in order to retest classified candidates, the candidates must be transmitted to a system for testing).
Regarding claim 10, Lamont-Zhu-Wouters-Yoshikawa teach the computer-implemented method of claim 2, wherein the first target item comprises a chemical compound, and wherein the plurality of test items comprises organic material (Lamont - the invention is applicable to a wide variety of complementary binding partners including any substance of biological or chemical origin ... examples of binding partners include, any antibody and corresponding antigen, hormone and hormone receptor ... drug and drug receptor ... any cell to cell interaction)([0031]).
Regarding claim 11, Lamont-Zhu-Wouters-Yoshikawa teach the computer-implemented method of claim 2, wherein determining the characteristic further comprises receiving, via a user interface, at least one of: a method of interaction of at least one of the first or second sets of matching test items with the plurality of targets, a gene target of the matching test items, a threshold of interaction of at least one of the first or second sets of matching test items with the plurality of targets, a type of test item of at least one of the first or second sets of matching test items, a type of target of the plurality of targets that interacted with at least one of the first or second sets of matching test items, or any combination thereof (Lamont - the method will involve performing all tests that are available on a biochip while only some of those tests are selected for further analysis ... a cut-off concentration selected by the user)([0015] and [0040]; a user is able to select a type of targe (i.e., a sub section) of test samples and a threshold of interaction (i.e., a cutoff)).
Regarding claim 13, Lamont-Zhu-Wouters-Yoshikawa teach the computer-implemented method of claim 2, wherein the first and second sets of matching test items comprises experimental data (Lamont - monitoring the properties of a biological or chemical sample comprises: a) carrying out a plurality of different tests on the sample to generate corresponding test data)([0006] and [0007]; experiential data is obtained).
Regarding system claims 14, 15, 18, 19, and 21, the claims generally correspond to method claims 2, 3, 6, 7, and 9, respectively, and recite similar features in system form; therefore, the claims are rejected under similar rationale.
Allowable Subject Matter
Claims 4, 5, 8, 12, 16, 17, 20 are objected to as being dependent upon a rejected base claim, but the claims would be allowable if rewritten in independent form to overcoming the rejections set forth (i.e., double patenting and 35 U.S.C. 112) and including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments, see page 7 of applicant's remarks, filed January 28, 2026, with respect to the 35 U.S.C. §112 rejection have been fully considered and are persuasive. The 35 U.S.C. §112 rejection has been withdrawn.
Applicant's arguments, see pages 7-10 of applicant's remarks, filed January 28, 2026, with respect to the 35 U.S.C. 103 rejection have been considered but are moot in view of the new ground(s) of rejection.
Conclusion
The prior art made of record on form PTO-892 and not relied upon is considered pertinent to applicant's disclosure. Applicant is required under 37 C.F.R. § 1.111(c) to consider the reference fully when responding to this action. The document cited therein and enumerated below teaches a method and apparatus for analyzing results.
US20040110172A1
US20070030287A1
US20100169788A1
US20160232457A1
US20170351844A1
US20180018386A1
US6125383
US6323852B1
US7043500B2
US10229245B2
US10453228B2
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 Yongjia Pan whose telephone number is (571)270-1177. The examiner can normally be reached Monday - Friday, 9:00 AM - 5:00 PM EST.
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/YONGJIA PAN/Primary Examiner, Art Unit 2118