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 .
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 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.
Restriction election
Applicant’s election with traverse of Group I (claims 1-26) in the reply filed on 07/22/2025 is acknowledged. The traversal is on the ground(s) that there is not an undue search burden. This is not found persuasive because the application is a 371 national stage application and does not require a search burden to show lack of unity.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election with traverse of Species B (claims 15) in the reply filed on 12/23/2025 is acknowledged. The traversal is on the ground(s) that there is not an undue search burden. This is not found persuasive because the application is a 371 national stage application and does not require a search burden to show lack of unity.
Claims 14 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claim Status
Claims 1-26 are pending.
Claim 27 is canceled.
Claims 14 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, as described above.
Claims 1-13, 15, and 17-26 are under examination.
Claim 10 is objected to.
Claims 1-13, 15, and 17-26 are rejected.
Priority
Applicant's claim for the benefit of a prior-filed application, PCT/KR2020/007664, filed 06/12/2020, is acknowledged, applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to App. No. 10-2019-0070900, filed 06/14/2019, and applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to App. No. 10-2019-0177063, filed 12/27/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 09/16/2021, 10/26/2021, and 07/22/2025 are in compliance with the provisions of 37 CFR 1.97 and have therefore been considered. Signed copies of the IDS documents are included with this Office Action.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 200, S200, S260, S270, S700, S710, S820, S910, S920, S950
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
35 U.S.C. 112(b)
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.
Claims 1-13, 15, and 17-26 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 25, and 26, limitation, recites “the technology provider terminal”.
There is insufficient antecedent basis for this limitation in the claim as there is no previous recitation of “a technology provider terminal”. The rejection may be overcome by amending the claim to “a technology provider terminal”. Claim(s) 2-23, 15, and 17-24 is/are rejected for the same reason because they depend from claim 1, respectively, and do not resolve the indefiniteness issue in those claims.
Claims 1, 25, and 26, limitation recites “wherein the development tool kit includes a performance test tool for the oligonucleotide to be included in the reagent, the performance test tool including one or more of software, a device, and instructional information”. The specification states that “the development tool kit is provided in the form of software and/ or a file and is stored to be classified by the data management module” [254]. The claim states the performance test tool which is in the development tool kit can include a device. It is unclear how a device may be provided in the form of software/ and or a file stored in a module.
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 1-13, 15, and 17-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 organizes judicial exception analysis into Steps 1, 2A (Prongs One and Two) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Framework with which to Evaluate Subject Matter Eligibility:
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter;
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1
With respect to Step 1: yes, the claims are directed to method, system, and process, i.e., a process, machine, or manufacture within the above 101 categories [Step 1: YES; See MPEP § 2106.03].
Step 2A, Prong One
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) are as follows:
Independent claims 1, 25, and 26:
allowing a developer terminal to access a technology provider's development tool kit, wherein the development tool kit includes a performance test tool for the oligonucleotide to be included in the reagent, the performance test tool including one or more of software, a device, and instructional information
allowing the received result to be reviewed by the technology provider terminal or by a monitoring module of a collaborative development system; and
allowing the developer terminal to access the review product, such that an oligonucleotide to be included in the reagent is selected
Dependent claim 8:
transmitting a request for evaluation to an evaluator terminal in response to the request for collaborative development and receiving an evaluation result of the feasibility of collaborative development from the evaluator terminal.
Dependent claim 9:
evaluating the feasibility of collaborative development by an evaluation management module of the collaborative development system in response to the request for collaborative development.
Dependent claim 11:
wherein the developer terminal is a terminal of a developer who is selected from a plurality of candidate developers.
Dependent claim 12:
wherein the development tool kit is provided from a technology provider selected from a plurality of candidate technology providers.
Dependent claim 13:
used for determination of a sensitivity or specificity of the oligonucleotide.
Dependent claim 15:
dispensing (localizing) the oligonucleotide in a designated position of a reaction vessel.
Dependent claim 18:
automatically designs a set of candidate oligonucleotides for detection of the target nucleic acid.
Dependent claim 19:
automatically converts raw performance data into processed performance data by a predetermined parameter
Dependent claim 20:
automatically sets a parameter value to cause a false positive or a false negative.
Dependent claim 21:
automatically converts processed performance data into a designated format of document.
Dependent claim 22:
reviewing of the result by the monitoring module or by the technology provider terminal are repeatedly performed for each test.
Dependent claims 3, 7 and 23 recite further steps that limit the judicial exceptions in independent claim 1 and, as such, also are directed to those abstract ideas. For example, claim 3 further limits the result of claim 2, claim 7 further limits the feature information of claim 1, and claim 23 further limits the review product of claim 1.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation because the method only requires a user to manually review, select, request, evaluate, determine, design, and convert . Without further detail as to the methodology involved in “result to be reviewed”, “reagent is selected“, “transmitting a request “, “evaluating the feasibility”, “developer who is selected”, “technology provider selected”, “determination of a sensitivity or specificity”, “designs a set of candidate oligonucleotides”, “converts raw performance data”, “reviewing of the result”, and “sets a parameter value” under the BRI, one may simply, for example, use pen and paper to develop reagents for detection of target nucleic acids.
Therefore, claim 1 and those claims dependent therefrom recite an abstract idea [Step 2A, Prong 1: YES; See MPEP § 2106.04].
Step 2A, Prong Two
Because the claims do recite judicial exceptions, direction under Step 2A, Prong Two, provides that the claims must be examined further to determine whether they integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d).III).
Additional elements, Step 2A, Prong Two
With respect to the instant recitations, the claims recite the following additional elements:
Independent claims 1, 25, and 26:
receiving from a requester terminal a request for collaborative development of a reagent containing an oligonucleotide for detection of a target nucleic acid, wherein the request for collaborative development includes feature information about the target nucleic acid to be detected using the reagent
a device
receiving from the developer terminal a result obtained from using the development tool kit, wherein the result includes performance data for the oligonucleotide
Dependent claim 2:
has already obtained or is able to obtain a clinical sample containing, or suspected of containing the target nucleic acid
Dependent claim 22:
receiving of the result from the developer terminal …are repeatedly performed for each test.
Dependent claims 4-6, 10, and 17 recite steps that further limit the recited additional elements in the claims. For example, claim 4 further limits the developer terminal of claim 1, claim 5 further limits the requester terminal of claim 1, claim 6 further limits the reagent of claim 1, claim 10 further limits evaluator terminal of claim 1, and claim 17 further limits the developmental tool kit of claim 1;
The claims also include non-abstract computing elements. For example, independent claim 1 includes a requester terminal, a developer terminal, and technology provider terminal. Claim 10 includes evaluator terminal. Claim 25 includes a system. Claim 26 includes a non-transitory computer-readable storage medium
Considerations under Step 2A, Prong Two
With respect to Step 2A, Prong Two, the additional elements of the claims do not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to data gathering, such as “receive” and “obtain”, perform functions of collecting the data needed to carry out the judicial exceptions. Data gathering and outputting do not impose any meaningful limitation on the judicial exceptions, or on how the judicial exceptions are performed. Data gathering and outputting steps are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
Further steps directed to additional non-abstract elements of “a requester terminal, a developer terminal, evaluator terminal, technology provider terminal, system, and a non-transitory computer-readable storage medium” do not describe any specific computational steps by which the “computer parts” perform or carry out the judicial exceptions, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. Hence, these are mere instructions to apply the judicial exceptions using a computer, and therefore the claim does not integrate that judicial exceptions into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc.… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer (MPEP 2106.05(f)).
Those steps directed to a device are adding insignificant extra-solution activity to the judicial exception and do not integrate the judicial exception into a practical application.
Thus, none of the claims recite additional elements which would integrate a judicial exception into a practical application, and the claims are directed to one or more judicial exceptions [Step 2A, Prong 2: NO; See MPEP § 2106.04(d)].
Step 2B (MPEP 2106.05.A i-vi)
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
The courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(II)(i)).
As such, the claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)). The data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
With respect to claims 1, 25, and 26 and those claims dependent therefrom, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. Hence, these are mere instructions to apply the judicial exceptions using a computer, which the courts have found to not provide significantly more when recited in a claim with a judicial exception (see MPEP 2106.06(A)). The specification also notes that computer processors and systems, as example, are commercially available or widely used at [356, 621, and 624]. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than the judicial exceptions (see MPEP 2106.05(b)I-III).
With respect to claims 1, 25, and 26 and those claims dependent therefrom, the device does not rise to the level of significantly more than the judicial exception. A PCR device is well-understood, routine, and conventional in the art. The background art in the specification discloses “other known nucleic acid amplification procedures include transcription- based amplification systems” [2-6].
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself [Step 2B: NO; See MPEP § 2106.05].
Therefore, the instant claims are not drawn to eligible subject matter as they are directed to one or more judicial exceptions without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-13, 15, 17-19, and 21-26 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Koehler et al. (WO 2003/065146 A2, published 08/07/2003, cited on IDS dated 07/22/2025).
Claim 1 is directed to a computer-implemented method for collaborative development of a reagent for detection of a target nucleic acid by a collaborative development system, comprising:
Koehler discloses a computer-implemented method for collaborative development of a target nuclei acid by a collaborative development system using a memory, a processor, and one or more programs stored in the memory and configured to be executed by the processor (see Abstract, Fig 4).
receiving from a requester terminal a request for collaborative development of a reagent containing an oligonucleotide for detection of a target nucleic acid, wherein the request for collaborative development includes feature information about the target nucleic acid to be detected using the reagent;
Koehler discloses receiving, using the processor, from a requester terminal, operated by a requestor a request for collaborative development of a reagent containing an oligonucleotide for detection of a target nucleic acid, wherein the request for collaborative development includes feature information about the target nucleic acid to be detected using the reagent (see Fig 18 and [00287]).
allowing a developer terminal to access a technology provider's development tool kit, wherein the development tool kit includes a performance test tool for the oligonucleotide to be included in the reagent, the performance test tool including one or more of software, a device, and instructional information; receiving from the developer terminal a result obtained from using the development tool kit, wherein the result includes performance data for the oligonucleotide;
Koehler discloses using the processor, a developer terminal to access a technology provider's development tool kit, wherein the development tool kit includes a performance test tool for the oligonucleotide to be included in the reagent, the performance test tool including one or more of software, a device, and instructional information; receiving from the developer terminal a result obtained from using the development tool kit, wherein the result includes performance data for the oligonucleotide (see Fig 18 - 19 and [00287], [00290-292])
allowing the received result to be reviewed by the technology provider terminal or by a monitoring module of a collaborative development system; and
Koehler discloses receiving from the developer terminal a result obtained from using the development tool kit, wherein the result includes performance data for the oligonucleotide (see Fig 18 - 19 and [00287], [00290-292])
allowing the developer terminal to access the review product, such that an oligonucleotide to be included in the reagent is selected.
Koehler discloses allowing, using the processor, the received result to be reviewed by the technology provider terminal or by a monitoring module of a collaborative development system; and allowing, using the processor, the developer terminal to access the review product, such that an oligonucleotide to be included in the reagent is selected (see Fig 4, [0006], [0078], claim 1: by means of probe selection, a reagent containing an oligonucleotide for detection of a target nucleic acid is inherently selected in the process).
Claim 2 is directed to the computer-implemented method of claim 1, wherein the developer terminal is a terminal of a developer who has already obtained or is able to obtain a clinical sample containing, or suspected of containing the target nucleic acid.
Koehler discloses following an investigator's request, a pre-validated assay can be sent to the investigator as a mixture in a single tube p. 00235].
Claim 3 is directed to the computer-implemented method of claim 2, wherein the result obtained from using the development tool kit includes a result of test for the obtained clinical sample.
Koehler discloses either a one-step or two-step process configuration can be used to analyze a sample for the presence or quantity of an RNA [00253]. Koehler further discloses in some configurations, a one-step process configuration can be used to detect and quantify an mRNA [00253].
Claim 4 is directed to the computer-implemented method of claim 1, wherein the developer terminal is a terminal of a developer who is located in a region where a disease associated with the target nucleic acid is breaking out or has broken out.
The area in which the developer terminal is located is adjustable accordingly in
conjunction with actual testing requirements.
Claim 5 is directed to the computer-implemented method of claim 1, wherein the requester terminal is identical to the developer terminal.
Koehler discloses the terms "consumer," "requestor," "user" and "investigator" are often used interchangeably herein [00122], the requester and developer terminal, with respect to which the requester terminal and the developer terminal are the same as is conventional in the art.
Claim 6 is directed to the computer-implemented method of claim 1, wherein the reagent is for detecting a plurality of target nucleic acids.
Koehler discloses that the target is a nucleic acid, such as viral DNA [00212].
Claim 7 is directed to the computer-implemented method of claim 1, wherein the feature information about the target nucleic acid includes: (i) a name of an organism containing the target nucleic acid; (ii) a name of a gene containing the target nucleic acid; (iii) a sequence of the target nucleic acid; (iv) an intended use of the reagent; (v) a name of a disease to be detected with the reagent; and/or (vi) a classification symbol of the disease to be detected with the reagent.
Koehler discloses providing information about a target nucleotide in the form of sequence information [p. 268, fig. 19]. Koehler further discloses information associated with a SNP location and/or an exon location [00290]. Koehler also discloses assay information including gene name and organism [p. 314, fig. 68]. On this basis, specific characteristic information about the target nucleic acid can be set or adjusted with respect to binding requirements.
Claim 8 is directed to the computer-implemented method of claim 1, further comprising transmitting a request for evaluation to an evaluator terminal in response to the request for collaborative development and receiving an evaluation result of the feasibility of collaborative development from the evaluator terminal.
Koehler discloses the evaluation of reagent deployment, on the basis of which the relevant operations of the evaluator terminal, evaluation management module and the like are capable of being routinely set up and adapted by a person skilled in the art [00340 and 00388].
Claim 9 is directed to the computer-implemented method of claim 1, further comprising evaluating the feasibility of collaborative development by an evaluation management module of the collaborative development system in response to the request for collaborative development.
Koehler discloses the evaluation of reagent deployment, on the basis of which the relevant operations of the evaluator terminal, evaluation management module and the like are capable of being routinely set up and adapted by a person skilled in the art [00340 and 00388].
Claim 10 is directed to the computer-implemented method of claim 1, wherein the evaluator terminal includes a technology provider terminal.
Koehler discloses the evaluation of reagent deployment, on the basis of which the relevant operations of the evaluator terminal, evaluation management module and the like are capable of being routinely set up and adapted by a person skilled in the art [00340 and 00388].
Claim 11 is directed to the computer-implemented method of claim 1, wherein the developer terminal is a terminal of a developer who is selected from a plurality of candidate developers.
Koehler discloses in various configurations of the present invention and referring to Figure 18, a computing system comprising a plurality of computers may be utilized to distribute information, products and services such as the custom assays and/or stock assays described above, to a user [00287].
Claim 12 is directed to the computer-implemented method of claim 1, wherein the development tool kit is provided from a technology provider selected from a plurality of candidate technology providers.
Koehler discloses in various configurations of the present invention and referring to Figure 18, a computing system comprising a plurality of computers may be utilized to distribute information, products and services such as the custom assays and/or stock assays described above, to a user [00287].
Claim 13 is directed to the computer-implemented method of claim 1, wherein any one or more of the device, the software, or the instructional information included in the performance test tool are used for determination of a sensitivity or specificity of the oligonucleotide.
Koehler discloses gene expression products ordered by a requester on demand can be available from the supplier with a FAM label and the TaqMan® MGB probe technology, which utilizes a nonfluorescent quencher for improved sensitivity and quantitation precision [00392]. Koehler further discloses MGBs furthermore increase the specificity of probe-target hybridization [00228].
Claim 15 is directed to the computer-implemented method of claim 13, wherein the software for determining the sensitivity or specificity of the oligonucleotide includes an instruction for dispensing (localizing) the oligonucleotide in a designated position of a reaction vessel.
Koehler discloses detectable by polymerase chain reaction, STSs can be useful for localizing and orienting the mapping and sequence data reported from many different laboratories and serve as landmarks on the developing physical map of the human genome [00200].
Claim 17 is directed to the computer-implemented method of claim 1, wherein the development tool kit further includes one or more of: (i) a design tool for the oligonucleotide; (ii) an analysis tool for a performance test; and (iii) a documentation tool for the performance test.
Koehler discloses of the 17 assays designed, only the top-scoring assay that had no design penalties assigned was sent to manufacturing [00391]. Koehler also discloses there are six other candidate assays that met the manufacturing quality control [00391]. Koehler further discloses cut-off for this particular target that can be chosen if for some reason the top-scoring assay fails along the downstream manufacturing and functional testing processes [00391]. Koehler also discloses to assist user in preparing a sequence for submission to the custom assay system, various embodiments of the present invention include a file builder program to prepare the submission file [00321]. Koehler further discloses in various configurations, an E-datasheet, or Assay Information File, can be provided with an assay [00517].
Claim 18 is directed to the computer-implemented method of claim 17, wherein the design tool for the oligonucleotide includes software that automatically designs a set of candidate oligonucleotides for detection of the target nucleic acid.
Koehler discloses of the 17 assays designed, only the top-scoring assay that had no design penalties assigned was sent to manufacturing [00391]. Koehler also discloses there are six other candidate assays that met the manufacturing quality control [00391].
Claim 19 is directed to the computer-implemented method of claim 17, wherein the analysis tool for the performance test includes software that automatically converts raw performance data into processed performance data by a predetermined parameter.
Koehler also discloses to assist user in preparing a sequence for submission to the custom assay system, various embodiments of the present invention include a file builder program to prepare the submission file [00321].
Claim 21 is directed to the computer-implemented method of claim 17, wherein the documentation tool for the performance test includes software that automatically converts processed performance data into a designated format of document.
Koehler further discloses in various configurations, an E-datasheet, or Assay Information File, can be provided with an assay [00517].
Claim 22 is directed to the computer-implemented method of claim 1, wherein the receiving of the result from the developer terminal and the reviewing of the result by the monitoring module or by the technology provider terminal are repeatedly performed for each test.
Koehler discloses repeated assessment or review of the performance of probes or reagents [p. 39, Fig. 43].
Claim 23 is directed to the computer-implemented method of claim 1, wherein the review product includes an indication of reperforming or approval of the performance test.
Koehler discloses repeated assessment or review of the performance of probes or reagents [p. 39, Fig. 43].
Claim 24 is directed to wherein the collaborative development system is configured to implement a plurality of collaborative developments.
Koehler discloses providing a web-based user interface configured to receive an order for one or more stock assays; providing a web-based user interface configured to receive a request for design of one or more custom assays and an order for said custom assays [claim 1] which reads on multiple requests being made on a web based interface.
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.
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.
A. Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koehler in view of Kim et al. (WO 2019/066572 A2, publisher 04/04/2019, newly cited).
Claim 20 is directed to the computer-implemented method of claim 17, wherein the analysis tool for the performance test includes software that automatically sets a parameter value to cause a false positive or a false negative.
Koehler is silent on software that automatically sets a parameter value to cause a false positive or a false negative.
However, Kim discloses method and device for analyzing target analyte in sample [title]. Kim further discloses the present invention may analyze the target analyte without false results, especially false positive results by using a fitting accuracy of a nonlinear function to a data set as a direct indicator for target analyte analysis [abstract].
In regards to claim(s) 20, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Koehler with Kim as they are both directed to analyzing target analyte in sample. The motivation would have been to combine the method of Koehler with the sigmoid function of Kim to analyze the target analyte without false results, especially false positive results by using a fitting accuracy of a nonlinear function to a data set as a direct indicator for target analyte analysis as disclosed by Kim [abstract]. Kim further discloses improving conventional baselining methods and have finally found to efficiently and easily perform a baselining by using a quadratic function fitted to a data set in a fitting region. One could have therefore combined the elements and that in combination, each element merely would have performed the same function as it did separately for a predictable.
Conclusion
No claims are allowed.
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/D.M.B./Examiner, Art Unit 1685
/Soren Harward/Primary Examiner, TC 1600