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 Claims
Claims 1-19 and 22 are pending in the present application with claims 1 and 22 being independent, as set forth in the Preliminary Amendment dated November 14, 2024.
Claim Objections
Claims 18-19 are objected to because of the following informalities:
In claims 18-19, "qPCR" should be changed to --quantitative real-time Polymerase Chain Reaction (qPCR)--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of claims 1 and 22 call for controlling display of the Ct distribution range and/or the count of examinees. However, it is unclear whether the Ct distribution range is referring to the first Ct distribution range and/or the second Ct distribution range and it is unclear whether the count of examinees is referring to the count of first examinees and/or the count of second examinees. For purposes of examination, the Examiner will assume the Ct distribution range is referring to the first Ct distribution range or the second Ct distribution range and it is unclear whether the count of examinees is referring to the count of first examinees or the count of second examinees.
In claim 9, it is not clear if the first occurrence of the Ct distribution range is referring to the first Ct distribution range or the second Ct distribution range. The Examiner will assume it is referring to the second Ct distribution range for purposes of examination.
The remaining claims are rejected based on their dependency from claim 1.
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 1-19 and 22 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claims 1-19 are directed to a method (i.e., a process) and claim 22 is directed to a computer device (i.e., a machine). Accordingly, claims 1-19 and 22 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 22 includes limitations that recite at least one abstract idea. Specifically, independent claim 22 recites:
A computer device comprising:
a memory configured to store at least one instruction; and
a processor configured to execute the one or more instructions stored in the memory, wherein the instructions, when executed by the processor, cause the processor to:
obtaining, by the processor, diagnostic results performed on a plurality of examinees in order to detect a respiratory virus or a human papilloma virus (HPV); wherein the respiratory virus comprises at least two types of respiratory viruses as a target virus and the HPV comprises at least two types of HPV subtypes as a target virus;
calculating, by the processor, from the diagnostic results, at least one of: (a) a first cycle threshold (Ct) distribution range obtained from a specific target virus in a single detection case where only the specific target virus among a plurality of target viruses is detected, and a second Ct distribution range obtained from the specific target virus in a concurrent detection case where one or more other target virus is detected together with the specific target virus; and (b) a count of a first examinees corresponding to the single detection case among the plurality of examinees, and a count of a second examinees corresponding to the concurrent detection case among the plurality of examinees; and
controlling, by the processor, display of at least one of the Ct distribution range and the count of examinees on a single screen of the computer device or a user terminal.
The Examiner submits that the foregoing underlined limitations recite "mental processes" because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). For instance, a medical professional could review PCR cycle threshold values for a specific target virus for a plurality of subjects where either only the specific target virus is detected (first type of subjects) or where both the specific target virus and one or more other target viruses are directed (second type of subjects), and then calculate and display (e.g., with pen and paper) cycle threshold distribution ranges and subject counts for each of the first and second types of subjects. These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis found to be "mental processes" in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
Furthermore, the foregoing underlined limitations recite "mathematical concepts" because they represent mathematical calculations similar to performing a resampled statistical analysis to generate a resampled distribution, SAP America, Inc. v. Investpic, LLC (898 F.3d 1161, 1163-65, 127 USPQ2d 1597, 1598-1600 (Fed. Cir. 2018)).
Accordingly, the claim recites at least one abstract idea.
Furthermore, dependent claims 2-12 and 14-17 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below:
-Claim 2 calls for filtering the diagnostic results by applying a predetermined first condition for at least one of a period, a season, a region, an age and a target virus, and a molecular diagnostic product, wherein the diagnostic results in the calculating, is the filtered diagnostic results. These steps are practically performable in the human mind with pen and paper ("mental processes").
-Claim 3 calls for displaying the first and second Ct distribution ranges in a "region" corresponding to the specific target virus which is practically performable in the human mind with pen and paper ("mental processes").
-Claim 4 calls for displaying at least one of a median value, a first quartile, a third quartile, an average value and a mode value is displayed in each of the first Ct distribution range and the second Ct distribution range which is practically performable in the human mind with pen and paper ("mental processes").
-Claim 5 calls for displaying at least one of an interquartile range (IQR) indicating a difference between the first quartile and the third quartile, a minimum value calculated based on the first quartile and the IQR, and a maximum value calculated based on the third quartile and the IQR in each of the first Ct distribution range and the second Ct distribution range which is practically performable in the human mind with pen and paper ("mental processes").
-Claim 6 calls for displaying the first Ct distribution range and the second Ct distribution range in a box plot method which is practically performable in the human mind with pen and paper ("mental processes").
-Claim 7 calls for displaying the counts of the first and second examinees in a "region" corresponding to the specific target virus which is practically performable in the human mind with pen and paper ("mental processes").
-Claim 8 calls for adding an identifiable mark for one or more target viruses of which a difference between the count of the first examinees and the count of the second examinees or a difference between a representative value of the first Ct distribution range and a representative value of the second Ct distribution range is not less than a predetermined reference value among the plurality of target viruses which is practically performable in the human mind with pen and paper ("mental processes").
-Claim 9 calls for adding an identifiable mark when a representative value of the Ct distribution range is not less than the representative value of the Ct distribution range in the single detection case for at least one target virus in which the count of the second examinees is not less than a predetermined reference value than the count of the first examinees among the plurality of target viruses which is practically performable in the human mind with pen and paper ("mental processes").
-Claim 10 calls for displaying information about one or more other target viruses detected together with the specific target virus in the concurrent detection case which is practically performable in the human mind with pen and paper ("mental processes").
-Claim 11 recites details regarding the information about the one or more other target viruses (that is displayed along with the specific target virus) including (a) a name of each of the one or more other target viruses detected together with the specific target virus; and (b) a count of examinees and/or a Ct distribution range in the concurrent detection case in which each of the one or more other target viruses are detected together with the specific target virus. Again, displaying such information along with the specific target virus is practically performable in the human mind with pen and paper ("mental processes").
-Claim 12 recites details regarding the information about the one or more other target viruses (that is displayed along with the specific target virus) including (a) names of a plurality of combinations for the one or more other target viruses detected together with the specific target virus, and (b) a count of examinees and/or a Ct distribution range in a concurrent detection case in which each of the plurality of combinations are detected together with the specific target virus. Again, displaying such information along with the specific target virus is practically performable in the human mind with pen and paper ("mental processes").
-Claim 14 calls for displaying information about the concurrent detection case of the specific target virus and information about the concurrent detection case of additional specific target virus which is practically performable in the human mind with pen and paper ("mental processes").
-Claim 15 calls for displaying information about a selected one of the specific target viruses which is practically performable in the human mind with pen and paper ("mental processes").
-Claim 16 recites how the at least two types of the respiratory viruses are selected from the group consisting of influenza virus, respiratory syncytial virus (RSV), adenovirus, enterovirus, parainfluenza virus (Ply), metapneumovirus (MPV), bocavirus, rhinovirus, and coronavirus which just further defines the "mental processes" discussed previously.
-Claim 17 recites how the at least two types of HPV subtypes are selected from the group consisting of HPV-16, -18, -26, -30, -31, -34, -35, -39, -45, -51, -52, -53, -56, -58, -59, -61, -66, -67, -68, -69, -70, and -73 belonging to a high-risk (HR) group which just further defines the "mental processes" discussed previously.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A computer device comprising:
a memory configured to store at least one instruction; and
a processor configured to execute the one or more instructions stored in the memory, wherein the instructions, when executed by the processor, cause the processor to:
obtaining, by the processor, diagnostic results performed on a plurality of examinees in order to detect a respiratory virus or a human papilloma virus (HPV); wherein the respiratory virus comprises at least two types of respiratory viruses as a target virus and the HPV comprises at least two types of HPV subtypes as a target virus;
calculating, by the processor, from the diagnostic results, at least one of: (a) a first cycle threshold (CTr) distribution range obtained from a specific target virus in a single detection case where only the specific target virus among a plurality of target viruses is detected, and a second CTr distribution range obtained from the specific target virus in a concurrent detection case where one or more other target virus is detected together with the specific target virus; and (b) a count of a first examinees corresponding to the single detection case among the plurality of examinees, and a count of a second examinees corresponding to the concurrent detection case among the plurality of examinees; and
controlling, by the processor, display of at least one of the CTr distribution range and the count of examinees on a single screen of the computer device or a user terminal.
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the computer device including memory, instruction, and processor and controlling display of the various information in the single screen of the computer device or a user terminal, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Furthermore, looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 22 and analogous independent claim 1 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 22 and analogous independent claim 1 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-Claim 13 recites how controlling the display of the information about the one or more other target viruses is performed corresponding to selection of a screen region displaying the second Ct distribution range or the count of the second examinees which just amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 18 recites how the diagnostic results are generated by using the identical qPCR device and the identical same extraction method which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claim 19 recites how the diagnostic results are generated by using the identical qPCR device, the identical extraction method, the identical target signaling mechanism, and the identical polymerase mastermix which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 22 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the computer device including memory, instruction, and processor and controlling display of the various information in the single screen of the computer device or a user terminal, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-Claim 13 recites how controlling the display of the information about the one or more other target viruses is performed corresponding to selection of a screen region displaying the second Ct distribution range or the count of the second examinees which just amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 18 recites how the diagnostic results are generated by using the identical qPCR device and the identical same extraction method which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claim 19 recites how the diagnostic results are generated by using the identical qPCR device, the identical extraction method, the identical target signaling mechanism, and the identical polymerase mastermix which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
Therefore, claims 1-19 and 22 are ineligible under 35 USC §101.
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.
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.
Claims 1-7, 10-12, 14, 16, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over NPL "Coinfection with severe acute respiratory syndrome coronavirus-2 and other respiratory viruses at a tertiary hospital in Korea" to Kim et al ("Kim") in view of U.S. Patent App. Pub. No. 2016/0115513 to Li ("Li"):
Regarding claim 1, Kim discloses a method for controlling display of molecular diagnostic results…, the method comprising:
obtaining diagnostic results performed on a plurality of examinees in order to detect a respiratory virus or a human papilloma virus (HPV) (sections 2.1 and 3.1 discuss obtaining positive and negative results for a plurality of individuals (examinees) for COVID-19 PCR testing and Real-Q RV II Detection kit testing (respiratory viruses));
wherein the respiratory virus comprises at least two types of respiratory viruses as a target virus (section 2.1 discloses COVID-19, Flu A/B, rhinovirus, etc.) and the HPV comprises at least two types of HPV subtypes as a target virus;
calculating, from the diagnostic results, at least one of: (a) a first cycle threshold (Ct) distribution range obtained from a specific target virus in a single detection case where only the specific target virus among a plurality of target viruses is detected (section 3.3, Figure 2, and the caption under Figure 2 illustrates/discuss box plots of a Ct distribution range for 2019-cCoV assay according to positive or negative results of Real-Q RV II Detection kit; accordingly, the right box plot in each graph in Figure 2 illustrates a first Ct distribution range in a single detection case where only COVID-19 is detected), and a second Ct distribution range obtained from the specific target virus in a concurrent detection case where one or more other target virus is detected together with the specific target virus (the left box plot in each graph in Figure 2 illustrates a second Ct distribution range in a concurrent detection case where one or more other target viruses is detected (e.g., Flu A/B, rhinovirus, etc. per section 2.1) together with COVID-19); and (b) a count of a first examinees corresponding to the single detection case among the plurality of examinees (section 3.1 discloses 117 individuals/examinees testing positive for COVID-19 but negative on the RQ assay), and a count of a second examinees corresponding to the concurrent detection case among the plurality of examinees (section 3.1 discloses 6 individuals/examinees that tested positive for both COVID-19 and on the RQ assay); and
controlling display of at least one of the CT distribution range and the count of examinees (Figure 2 presents a display of the first and second Ct distribution ranges and the counts of the first and second examinees while Table 1 presents a display of the counts of examinees)…
However, Kim appears to be silent regarding the method being performed by a computer device and the control of the display being on a single screen of the computer device or a user terminal.
Nevertheless, Li teaches ([0122], [0143]) that it was known in the healthcare informatics art to utilize a computer 101 to obtain information/diagnostic results regarding an amplified product, perform additional manipulations of the information, generate a report containing the processed information (e.g., including Ct values, etc. per [0122]), and display the report on a display screen (a "single screen") of an electronic display 112 to advantageously facilitate rapid and accurate reporting of nucleic acid amplification analyses.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the method of Kim to be performed by a computer device such that control of the display is on a single screen of the computer device or a user terminal as taught by Li to advantageously facilitate rapid and accurate reporting of nucleic acid amplification analyses. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 2, the Kim/Li combination discloses the method of claim 1, further including:
filtering the diagnostic results by applying a predetermined first condition for at least one of a period, a season, a region, an age and a target virus, and a molecular diagnostic product, wherein the diagnostic results in the calculating, is the filtered diagnostic results (section 3.1 of Kim discloses how 13,717 individuals underwent COVID-19 testing with 123 testing positive while section 3.3 discloses how the individuals with the positive COVID-19 test are depicted in Figure 2; therefore, being positive for COVID-19 is a "predetermined first condition" (target virus) by which all the results are filtered and then such filtered results are used in the above-discussed calculating of the Ct ranges and examinee counts).
Regarding claim 3, the Kim/Li combination discloses the method of claim 1, further including wherein the controlling the display of the computer device or the user terminal comprises:
providing a region corresponding to the specific target virus on the single screen (Figure 2 of Kim shows a "region" corresponding to COVID-19 which is on the "single screen" (as controlled by the computer device or user terminal per the above-noted combination with Li)), and
controlling that the first Ct distribution range and the second Ct distribution range are displayed in the region (the first and second Ct distribution ranges are displayed in the region of Figure 2 of Kim (as controlled by the computer device or user terminal per the above-noted combination with Li)).
Regarding claim 4, the Kim/Li combination discloses the method of claim 3, further including wherein the controlling the display of the computer device or the user terminal comprises:
controlling that at least one of a median value, a first quartile, a third quartile, an average value and a mode value is displayed in each of the first Ct distribution range and the second Ct distribution range (the central horizontal line in the first and second Ct distribution ranges of Figure 2 of Kim is the median, the upper and lower horizontal lines are the first and third quartiles, etc. (as controlled by the computer device or user terminal per the above-noted combination with Li)).
Regarding claim 5, the Kim/Li combination discloses the method of claim 4, further including wherein the controlling the display of the computer device or the user terminal comprises:
controlling that at least one of an interquartile range (IQR) indicating a difference between the first quartile and the third quartile, a minimum value calculated based on the first quartile and the IQR, and a maximum value calculated based on the third quartile and the IQR is further displayed in each of the first Ct distribution range and the second Ct distribution range (difference/distance from the first to the third quartile horizontal lines in Figure 2 of Kim is the interquartile range (IQR) (as controlled by the computer device or user terminal per the above-noted combination with Li)).
Regarding claim 6, the Kim/Li combination discloses the method of claim 3, further including wherein the controlling the display of the computer device or the user terminal comprises:
controlling that each of the first Ct distribution range and the second Ct distribution range is displayed in a box plot method (the first and second Ct distribution ranges are displayed in a box plot method in Figure 2 of Kim (as controlled by the computer device or user terminal per the above-noted combination with Li)).
Regarding claim 7, the Kim/Li combination discloses the method of claim 1, further including wherein the controlling the display of the computer device or the user terminal comprises:
providing a region corresponding to the specific target virus on the single screen, and controlling that the count of the first examinees and the count of the second examinees are displayed in the region (Table 1 of Kim presents a display including a region corresponding to the specific target virus (COVID-19) and including the first count of examinees (e.g., 117) and the second count of examinees (e.g., 6)) (as controlled by the computer device or user terminal via a single screen per the above-noted combination with Li)).
Regarding claim 10, the Kim/Li combination discloses the method of claim 1, further including controlling display of information about one or more other target viruses detected together with the specific target virus in the concurrent detection case of the computer device or the user terminal (Table 1 of Kim presents a display of information about positive RQ (other target viruses) along with positive COVID-19 (specific target virus) in the concurrent detection case, Table 2 of Kim presents a display including information of one or more of AdV, HRV, etc. (other target viruses) along with COVID-19 (specific target virus) in the concurrent detection cases, and Figure 2 of Kim shows Ct values for individuals in the concurrent detection case (where display of such information is controlled with the computer device or user terminal per the above-noted combination with Li)).
Regarding claim 11, the Kim/Li combination discloses the method of claim 10, further including wherein the information about the one or more other target viruses comprises: (a) a name of each of the one or more other target viruses detected together with the specific target virus (see Table 2 of Kim); and (b) a count of examinees and/or a CTr distribution range in the concurrent detection case in which each of the one or more other target viruses are detected together with the specific target virus (Tables 1 and 2 of Kim include counts of individuals in the concurrent detection case (where display of such information is controlled with the computer device or user terminal per the above-noted combination with Li)).
Regarding claim 12, the Kim/Li combination discloses the method of claim 10, further including wherein the information about the one or more other target viruses comprises: (a) names of a plurality of combinations for the one or more other target viruses detected together with the specific target virus (see Table 2 of Kim), and (b) a count of examinees and/or a CTr distribution range in a concurrent detection case in which each of the plurality of combinations are detected together with the specific target virus (Table 1 of Kim illustrates counts and counts can be gleaned from the information in Table 2 of Kim (where display of such information is controlled with the computer device or user terminal per the above-noted combination with Li)).
Regarding claim 14, the Kim/Li combination discloses the method of claim 1, further including controlling display of information about the concurrent detection case of the specific target virus and information about the concurrent detection case of additional specific target virus on a single screen of the computer device or the user terminal (Tables 1 and 2 and Figure 2 of Kim display information about the concurrent detection case of the specific target virus and information about the concurrent detection case of additional specific target virus as controlled by the computer device or user terminal via a single screen per the above-noted combination with Li)).
Regarding claim 16, the Kim/Li combination discloses the method of claim 1, further including wherein the at least two types of the respiratory viruses are selected from the group consisting of influenza virus, respiratory syncytial virus (RSV), adenovirus, enterovirus, parainfluenza virus (Ply), metapneumovirus (MPV), bocavirus, rhinovirus, and coronavirus (section 2.1 of Kim discloses influenza virus, rhinovirus, COVID-19, etc.).
Regarding claim 22, the Kim/Li combination discloses a computer device comprising: a memory configured to store at least one instruction; and a processor configured to execute the one or more instructions stored in the memory (Li discloses a computer 101 that includes memory with instructions, processor, etc. per [0147]).
The remaining limitations of claim 22 are disclosed by the Kim/Li combination as discussed above in relation to claim 1. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the method of Kim to be performed by a computer device including a memory configured to store at least one instruction; and a processor configured to execute the one or more instructions stored in the memory, as taught by Li to advantageously facilitate rapid and accurate reporting of nucleic acid amplification analyses. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over NPL "Coinfection with severe acute respiratory syndrome coronavirus-2 and other respiratory viruses at a tertiary hospital in Korea" to Kim et al ("Kim") in view of U.S. Patent App. Pub. No. 2016/0115513 to Li ("Li"), and further in view of U.S. Patent App. Pub. No. 2021/0272654 to Thaker et al. ("Thaker"):
Regarding claim 13, the Kim/Li combination discloses the method of claim 10, but appears to be silent regarding wherein the controlling the display of the information about the one or more other target viruses is performed corresponding to selection of a screen region displaying the second Ct distribution range or the count of the second examinees.
Nevertheless, Thaker teaches ([0522]-[0523] and Figure 4C) that it was known in the healthcare informatics art to display additional information regarding a graphical representation upon clicking on (selection of) the graphical representation which would advantageously allow a user to bring up such additional information at a desired time upon selection.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the controlling the display of the information about the one or more other target viruses of the Kim/Li combination to be performed corresponding to selection of a screen region displaying the second Ct distribution range or the count of the second examinees similar to as taught by Thaker to advantageously allow a user to bring up such additional information at a desired time upon selection. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 15, the Kim/Li combination discloses the method of claim 14, but appears to be silent regarding when any one of the specific target viruses is selected among the specific target viruses, controlling display of information about a concurrent detection case of the selected any one specific target virus of the computer device or the user terminal.
Nevertheless, Thaker teaches that it was known in the healthcare informatics art to display additional information regarding a graphical representation upon clicking on (selection of) the graphical representation which would advantageously allow a user to bring up such additional information at a desired time upon selection.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have controlled the display of information by the computer device about a concurrent detection case when one of the specific target viruses is selected in the system of the Kim/Li combination similar to as taught by Thaker to advantageously allow a user to bring up such additional information at a desired time upon selection.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over NPL "Coinfection with severe acute respiratory syndrome coronavirus-2 and other respiratory viruses at a tertiary hospital in Korea" to Kim et al ("Kim") in view of U.S. Patent App. Pub. No. 2016/0115513 to Li ("Li"), and further in view of Int'l Pub. No. WO 2016/072662 to Choi et al. ("Choi"):
Regarding claim 17, the Kim/Li combination discloses the method of claim 1, but appears to be silent regarding wherein the at least two types of HPV subtypes are selected from the group consisting of HPV-16, -18, -26, -30, -31, -34, -35, -39, -45, -51, -52, -53, -56, -58, -59, -61, -66, -67, -68, -69, -70, and -73 belonging to a high-risk (HR) group.
Nevertheless, Choi teaches (Abstract) that it was known in the healthcare informatics art to use a detection probe capable of binding to HPV DNA to diagnose coinfections by one or more HPV genotypes (subtypes) from HPV-16, 18, 31, 53, etc. belonging to a high-risk group ([4] on page 1) and to display analytics regarding the same (Figures 2-5) to advantageously facilitate screening for cervical cancer and the like ("Background Art").
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for at least two types of HPV subtypes to be selected from the group consisting of HPV-16, -18, -26, -30, -31, -34, -35, -39, -45, -51, -52, -53, -56, -58, -59, -61, -66, -67, -68, -69, -70, and -73 belonging to a high-risk (HR) group in the system of the Kim/Li combination as taught by Choi to advantageously facilitate screening for cervical cancer and the like. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over NPL "Coinfection with severe acute respiratory syndrome coronavirus-2 and other respiratory viruses at a tertiary hospital in Korea" to Kim et al ("Kim") in view of U.S. Patent App. Pub. No. 2016/0115513 to Li ("Li"), and further in view of NPL "Why qPCR is the gold standard for COVID-19 testing" to Thermo Fisher Scientific ("Thermo Fisher"):
Regarding claim 18, the Kim/Li combination discloses the method of claim 1, further including wherein the diagnostic results are characterized in that they are diagnostic results generated by using the identical …PCR device and the identical same extraction method (sections 2.1, 3.1, 3.2 of Kim discloses using the same Allplex 2019-nCoV Assay PCR kits with nasal swab (i.e., identical PCR device and same extraction method).
However, the Kim/Li combination appears to be silent regarding the PCR device specifically being a qPCR device.
Nevertheless, Thermo Fisher teaches that it was known in the healthcare informatics art to utilize an RT-qPCR technique to screen for COVID-19 because it can not only detect the virus's genetic information but also quantify the amount therefore that is present in a sample.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the PCR device of the Kim/Li combination to specifically be a qPCR device as taught by Thermo Fisher to advantageously detect not only the virus's genetic information but also quantify the amount therefore that is present in a sample. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 19, the Kim/Li combination discloses the method of claim 18, further including wherein the diagnostic results are characterized in that they are diagnostic results generated by using the identical …PCR device (sections 2.1, 3.1, 3.2 of Kim discloses using the same Allplex 2019-nCoV Assay PCR kits), the identical extraction method (nasal swab), the identical target signaling mechanism (E/RdRP/N genes per section 3.3 and caption for Figure 2), and the identical polymerase mastermix (the mastermix would be included in the kit).
However, the Kim/Li combination appears to be silent regarding the PCR device specifically being a qPCR device.
Nevertheless, Thermo Fisher teaches that it was known in the healthcare informatics art to utilize an RT-qPCR technique to screen for COVID-19 because it can not only detect the virus's genetic information but also quantify the amount therefore that is present in a sample.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the PCR device of the Kim/Li combination to specifically be a qPCR device as taught by Thermo Fisher to advantageously detect not only the virus's genetic information but also quantify the amount therefore that is present in a sample. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/JONATHON A. SZUMNY/ Primary Examiner, Art Unit 3686