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 .
Claims Status
Claims 1-9 & 11-24 filed on 05/23/2025 are pending. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant application. Response to Applicant’s argument follow. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
The double patenting rejections are moot in view of the terminal disclaimer filed on 05/23/2025 that was approved. Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 112
112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 & 11-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding newly amended claims 1 & 24, claim 1 and claim 24 have been amended to recite the limitation “wherein a power of the light is from 85 to 250 mW”. The specification of the instant application has been thoroughly reviewed but support for this newly added limitation was not found. While there is no in haec verba requirement, newly added claims or claim limitations must be support in the specification through express, implicit, or inherent disclosure. In the instant situation, this limitation of “a power of the light is from 85 to 250 mW” is not expressly recited in the specification of the instant application. Additionally, there also does not appear to be implicit or inherent support for this limitation of power because it is not clear from the teachings of the specification where the error occurred. It is not clear if the specification was
A) meant to include the proper units for light intensity :W/m2 instead of mW or
B) if the specification was meant denote mW for power instead of light intensity.
In the instance situation, the error is not clear or obvious. Since the response does not explain how the newly added limitations are implicitly or inherently disclosed, the claims are rejected under 35 USC 112(a). In response, applicant may cancel the new matter, or provide explanations as to where the limitations find express, implicit, or inherent support.
Claims 2-9 & 11-23 are rejected due to their dependence on claim 1.
112(b)
Claims 1-9 & 11-24 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding newly amended claims 1 and 24, the recitation of “a power of light is from 85 to 250 mW” in lines 5-6 of the claims is unclear. Does “a power of light” refer to the wattage that is emitted from the light source to be from 85 to 250 mW or does it refer to the amount of power from a light being received by the sample is 85 to 250 mW?
Claims 2-9 & 11-23 are rejected due to their dependence on claim 1.
Claim Rejections - 35 USC § 103
Claim(s) 1-4, 6-9, 11, 14-19, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karim et al. ("Propidium monoazide reverse transcriptase PCR and RT-qPCR for detecting infectious enterovirus and norovirus", March 18th, 2015, pages 51-61, Journal of Virological Methods), in view of Hu et al. ("Prevalence and Genetic Diversity Analysis of Human Coronavirus OC43 among Adult Patient with Acute Respiratory Infections in Beijing, 2012", July 2nd, 2014, pages 1-7, PLOS One) as evidenced by Biotium (Bitotium, PMA (Propidium Monoazide)) regarding the optimal wavelength of absorption for the PMA dye.
Regarding newly amended claim 1, Karim et al. teaches a method of detecting infectivity of enterovirus and norovirus and dividing the samples into samples treated with PMA and light and then control samples with alternative treatments (test samples one and two), (section 2.7; section 3.2 paragraph 1 line 1; abstract lines 4-5), treating the non-control sample with an intercalating dye (PMA), (section 2.7; section 3.2 paragraph 1 lines 1-2; abstract lines 6-7), exposing the non-control sample to light for photo-activation (section 2.7; section 3.2 paragraph 1 lines 1-2; abstract lines 6-7), amplifying the targeted nucleic acids in the non-control and control samples (section 2.9; section 3.2 paragraph 1 lines 2-3; abstract lines 6-7), and determining infectivity of enterovirus or norovirus based on the amplification results of the non-control and control samples (section 2.7; section 3.2 paragraph 1 lines 19-21; abstract lines 7-9). The non-control samples treated with both PMA and light exposure are interpreted as the claimed first sample recited in claim 1, and the control samples without PMA or light, with PMA but no light, or without PMA but with light are interpreted as the claimed second sample recited in claim 1. Additionally, it is noted that the claim has been amended to remove intensity and recite power, however, as discussed above it is unclear whether “a power of light is from 85 to 250 mW” is referring to the wattage of power that is emitted from a light source being from 85 to 250 mW or if it is referring to a wattage of power that is received by the sample is from 85 to 250 mW. Therefore, the claims have been given their broadest reasonable interpretation to encompass the teachings of Karim et al. of 800 W light delivered to a 1.5mL centrifuge tube (pg. 53-54 paragraph bridging pg. 53 & pg. 54 lines 7-13).
Karim et al. fails to teach this method for detection of infectivity of human coronavirus in claim 1.
Hu et al. teaches a method for nucleic acid detection of a human coronavirus infection OC43 (HCoV-OC43) (Nucleic acid detection and sequencing of the S and N gene of HCoV-OC43 section paragraph 1 lines 1-30) and the specific forward and reverse primer pair sequence for detection of HCoV-OC43, (Nucleic acid detection and sequencing of the S and N gene of HCoV-OC43 section paragraph 1 lines 10-12). Hu et al. also teaches that the “gold standard” for determining virus infectivity is a time-consuming process and has led researchers to prefer RT-PCR molecular detection methods to screen for human coronavirus infection (discussion section paragraph 2 lines 1-5).
Karim et al. and Hu et al. are both considered to be analogous to the claimed invention because they are both in the same field of detection of virus infection with nucleic acid amplification methods. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karim et al. to incorporate the teachings of Hu et al. and develop a method for detecting the infectivity of a human coronavirus and for using the specific forward and reverse primer pair. Doing so would allow for the detection between viable and nonviable human coronavirus to determine which cells are still infectious at the time of sample collection.
Regarding claim 2, Karim et al. teaches the second sample is not subject to dye treatment (PMA) and photo-activation (Light) (table 3 - Virus, PMA, and Light columns under infectious poliovirus row; table 4 - Virus, PMA, and Light columns under infectious MNV-1 and infectious Norwalk virus rows).
Regarding claim 3, Karim at el., teaches the second sample is subject to dye treatment (PMA) but is not subject to photo-activation (Light) (table 3 - Virus, PMA, and Light columns under infectious poliovirus row; table 4 - Virus, PMA, and Light columns under infectious MNV-1 and infectious Norwalk virus rows).
Regarding claim 4, Karim et al. teaches the second sample is not subject to dye treatment (PMA) but is subject to photo-activation (Light) (table 4 - Virus, PMA, and Light columns under infectious MNV-1 and infectious Norwalk virus rows).
Regarding claim 6, Karim et al. teaches treating the samples with dye treatment for a duration of 5 minutes (section 2.7 paragraph 1 lines 9-10).
Regarding claim 7, Karim et al. teaches the duration of photo-activation for 3 minutes (section 2.7 paragraph 1 lines 11-13).
Regarding claim 8, Karim et al. teaches exposing the sample to visible light for the photo-activation step (section 2.7 paragraph 1 lines 12).
Regarding claim 9, Karim et al. teaches using propidium monoazide (PMA) from Biotium (Bitotium, PMA (Propidium Monoazide)) which as evidenced by Biotium the optimal wavelength of absorption for the PMA dye is 464nm (section 2.7 paragraph 1 line 2).
Regarding claim 11, Karim et al. teaches incubating the sample on ice during the photo-activation step which would indicate that the samples are being photo-activated at a temperature less than 37°C, (section 2.7 paragraph 1 lines 9-12).
Regarding claim 14, Karim et al. teaches amplifying the nucleic acids with RT-PCR, (section 2.9 paragraph 1 lines 1-23; section 3.2).
Regarding claim 15, Karim et al. teaches detecting the amplified nucleic acids by end point detection, (section 2.9 paragraph 1 lines 1-23; section 2.10 paragraph 1 lines 1-8).
Regarding claim 16, Karim et al. teaches determining the infectivity with a formula based on the differences between the mean Cq value and the experimental test Cq value, (section 2.12 paragraph 1 lines 1-7; table 3, 4, and 5).
Regarding claim 17, Karim et al. teaches reverse transcribing a target RNA sequence and then amplifying with pairs of primers for the targeted RNA, (section 2.11 paragraph 1 lines 1-19; section 3.1 paragraph lines 2-5; table 1).
Regarding claim 18, Karim et al. teaches the target nucleic acid is detected by a probe, (section 2.11 paragraph 1 lines 2-3; section 3.1 paragraph 1 lines 3-5; table 1).
Regarding claim 19, Hu et al. teaches the human coronavirus is HCoV-OC43 (abstract, line 1). Hu et al. teaches a molecular detection method of human coronaviruses and applied this method to the specific HCoV-OC43 virus (abstract line 1; Introduction section paragraph 2 lines 1-8; discussion paragraph 2 lines 1-5). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Hu et al. to incorporate the teachings of Karim et al. with a reasonable expectation of success to detect the infectivity of multiple types of human coronaviruses because the “gold standard” is time-consuming.
Regarding claim 23, Karim et al. teaches use of primer pairs for detecting virus, (section 2.11 paragraph 1 lines 1-19; section 3.1 paragraph lines 2-5; table 1). Hu et al. teaches the use of specific forward primer 5′-GAACTATGGCATTTGGATACAGG-3′ and reverse primer 5′-ATGACTGCAAATAGCCCAAATT-3′ (Nucleic acid detection and sequencing of the S and N gene of HCoV-OC43 section paragraph 1 lines 1-30). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Hu et al. to incorporate the teachings of Karim et al. with a reasonable expectation of success to detect the infectivity of HCoV-OC43 with the specific primer pair because doing so would allow for the detection between viable and nonviable HCoV-OC43 to determine which cells are still infectious at the time of sample collection.
Regarding claim newly amended 24, Karim et al. teaches a method for evaluating membrane integrity of a virus based on the amplification results of the first and second sample (introduction section, paragraph 5, lines 4-14). Additionally, it is noted that the claim has been amended to remove intensity and recite power, however, as discussed above it is unclear whether “a power of light is from 85 to 250 mW” is referring to the wattage of power that is emitted from a light source being from 85 to 250 mW or if it is referring to a wattage of power that is received by the sample is from 85 to 250 mW. Therefore, the claims have been given their broadest reasonable interpretation to encompass the teachings of Karim et al. of 800 W light delivered to a 1.5mL centrifuge tube (pg. 53-54 paragraph bridging pg. 53 & pg. 54 lines 7-13). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Hu et al. to incorporate the teachings of Karima et al. with a reasonable expectation of success to evaluate the membrane integrity of a human coronavirus because doing so would allow for further and alternative methods for determining which cells are still infectious at the time of sample collection.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karim et al. ("Propidium monoazide reverse transcriptase PCR and RT-qPCR for detecting infectious enterovirus and norovirus", March 18th, 2015, pages 51-61, Journal of Virological Methods) and Hu et al. ("Prevalence and Genetic Diversity Analysis of Human Coronavirus OC43 among Adult Patient with Acute Respiratory Infections in Beijing, 2012", July 2nd, 2014, pages 1-7, PLOS One), as applied to claim 1 above, and in further view of ElizaquÍvel, Aznar, & Sánchez ("Recent developments in the use of viability dyes and quantitative PCR in the food microbiology field", October 8th, 2013, pages 1-13, Journal of Applied Microbiology).
The teachings of Karim et al. and Hu et al. with respect to claim 1 are discussed above.
Regarding claim 5, Karim et al. teaches the intercalating dye is PMA (section 2.7 paragraph 1 lines 1-2; section 3.2 paragraph 1 lines 1-2; tables 3, 4 & 5). Karim et al. does not teach an intercalating dye that is EMA. However, Karim et al. teach PMA and EMA are similar photo-reactive DNA intercalating dyes that covalently bind to DNA upon exposure to intense light (introduction section paragraph 4 lines 1-3). It would have been obvious to substitute PMA for EMA with a reasonable expectation for success because PMA and EMA are similar photo-reactive DNA intercalating dyes.
In addition, ElizaquÍvel, Aznar, & Sánchez teaches that reagent D is a nucleic acid intercalating dye that contains a light sensitive substance that can only penetrate the cell membrane of dead cells and then covalently bind to DNA and then prevent amplification of the DNA through PCR after being exposed to visible light (introduction section paragraph 5 lines 13-26). It would have been obvious to substitute PMA for Reagent D with a reasonable expectation for success because PMA and Reagent D are similar photo-reactive DNA intercalating dyes.
Karim et al., Hu et al. and ElizaquÍvel, Aznar, & Sánchez are all considered to be analogous to the claimed invention because they are all in the same field of detection of nucleic acids with the use of an intercalating dye to determine cell viability. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karim et al. and Hu et al. to incorporate the teachings of ElizaquÍvel, Aznar, & Sánchez. The person of ordinary skill in the art would have been motivated to develop a method for detecting the infectivity of a human coronavirus using an intercalating dye allowing for the detection between viable and nonviable human coronavirus.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karim et al. ("Propidium monoazide reverse transcriptase PCR and RT-qPCR for detecting infectious enterovirus and norovirus", March 18th, 2015, pages 51-61, Journal of Virological Methods) and Hu et al. ("Prevalence and Genetic Diversity Analysis of Human Coronavirus OC43 among Adult Patient with Acute Respiratory Infections in Beijing, 2012", July 2nd, 2014, pages 1-7, PLOS One), as applied to claim 1 above, and in further view of Qiagen QIAamp® 96 Viral RNA Handbook (pages 1-32, 06/2020).
The teachings of Karim et al. and Hu et al. with respect to claim 1 are discussed above.
Regarding claim 12, Karim et al. and Hu et al. fail to teach the first and second sample are extracted with a buffer system followed by nucleic acid purification and amplification.
The Qiagen® 96 Viral RNA Handbook teaches a method for extracting the viral RNA from a sample with a buffer system, then purifying and amplifying the sample (introduction section page 6 lines 2-3; principle and procedure section page 7 lines 4-10).
Karim et al., Hu et al. and the Qiagen QIAamp® 96 Viral RNA Handbook are all considered to be analogous to the claimed invention because they are all in the same field of detection of nucleic acids with reverse transcriptase nucleic acid amplification methods requiring the purification and buffering of the RNA from the virus sample. In addition, the Qiagen QIAamp® 96 Viral RNA Handbook teaches the benefit of eliminating the risk of cross contamination to allow for the proper handling of viral RNA samples. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karim et al. and Hu et al. to incorporate the teachings of Qiagen QIAamp® 96 Viral RNA Handbook. The person of ordinary skill in the art would have been motivated to develop a method for detecting the infectivity of a human coronavirus using a buffer system to aid in extraction nucleic acids followed with purifying and amplifying the sample allowing for the detection between viable and nonviable human coronavirus to then detect infectious sample through RT-PCR.
Regarding claim 13, Karim et al. and Hu et al. fail to teach the first sample and second sample are mixed and extracted with a buffer system and then purified and amplified.
The Qiagen® 96 Viral RNA Handbook teaches a method for mixing the buffer system and then extracting and amplifying the viral RNA sample (introduction section page 6 lines 2-3; removal of residual contaminants section page 9 lines 1-4).
Karim et al., Hu et al. and the Qiagen QIAamp® 96 Viral RNA Handbook are all considered to be analogous to the claimed invention because they are all in the same field of detection of nucleic acids with reverse transcriptase nucleic acid amplification methods requiring the purification and buffering of the RNA from the virus sample. In addition, the Qiagen QIAamp® 96 Viral RNA Handbook teaches the benefit of eliminating the risk of cross contamination to allow for the proper handling of viral RNA samples. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karim et al. and Hu et al. to incorporate the teachings of Qiagen QIAamp® 96 Viral RNA Handbook and develop a method for detecting the infectivity of a human coronavirus using a mixed buffer system to aid in extraction and amplification of purified nucleic acids. Doing so would allow for the detection between viable and nonviable human coronavirus through purifying RNA from a virus sample to then detect infectious sample through RT-PCR.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karim et al. ("Propidium monoazide reverse transcriptase PCR and RT-qPCR for detecting infectious enterovirus and norovirus", March 18th, 2015, pages 51-61, Journal of Virological Methods) and Hu et al. ("Prevalence and Genetic Diversity Analysis of Human Coronavirus OC43 among Adult Patient with Acute Respiratory Infections in Beijing, 2012", July 2nd, 2014, pages 1-7, PLOS One) as applied to claims 1 and 19, in further view of Donati et al. (U.S. Patent # 11,001,901).
Karim et al. and Hu et al. fails to teach this method for detection of infectivity of human coronavirus with the specific forward primer 5'-ACAGGTACGTTAATAGTTAATAGCGT-3' (SEQ ID NO: 1) and a reverse primer 5'-ATATTGCAGCAGTACGCACACA-3' (SEQ ID NO: 2). However, Donati et al. teaches a method for using those specific forward and reverse primers for detection of SARS-CoV-2, (Column 4, lines 20-26).
Karim et al., Hu et al. and Donati et al. are all considered to be analogous to the claimed invention because they are all in the same field of detection of virus infection with nucleic acid amplification methods. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karim et al. and Hu et al. to incorporate the teachings of Donati et al. and develop a method for detecting the infectivity of a human coronavirus using the specific forward and reverse primers of SEQ ID NO: 1 and SEQ ID NO: 2. Doing so would allow for the detection between viable and nonviable human coronavirus to determine which cells are still infectious at the time of sample collection.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karim et al. ("Propidium monoazide reverse transcriptase PCR and RT-qPCR for detecting infectious enterovirus and norovirus", March 18th, 2015, pages 51-61, Journal of Virological Methods) and Hu et al. ("Prevalence and Genetic Diversity Analysis of Human Coronavirus OC43 among Adult Patient with Acute Respiratory Infections in Beijing, 2012", July 2nd, 2014, pages 1-7, PLOS One) as applied to claims 1 and 19, in further view of Yuan, Wu, & Ma. (CN. Patent # 112029899 A, English translation obtained from PE2E SEARCH on 9/06/24).
Karim et al. and Hu et al. fails to teach this method for detection of infectivity of human coronavirus with the specific forward primer 5'-CACATTGGCACCCGCAATC-3' (SEQ ID NO: 3) and a reverse primer 5'-GAGGAACGAGAAGAGGCTTG-3' (SEQ ID NO: 4). However, Yuan, Wu, & Ma teaches a method for using those specific forward and reverse primers for detection of SARS-CoV-2, (page 3 lines 12-13).
Karim et al., Hu et al. and Yuan, Wu, & Ma are all considered to be analogous to the claimed invention because they are all in the same field of detection of virus infection with nucleic acid amplification methods. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karim et al. and Hu et al. to incorporate the teachings of Yuan, Wu, & Ma and develop a method for detecting the infectivity of a human coronavirus using the specific forward and reverse primers of SEQ ID NO: 3 and SEQ ID NO: 4. Doing so would allow for the detection between viable and nonviable human coronavirus to determine which cells are still infectious at the time of sample collection.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karim et al. ("Propidium monoazide reverse transcriptase PCR and RT-qPCR for detecting infectious enterovirus and norovirus", March 18th, 2015, pages 51-61, Journal of Virological Methods) and Hu et al. ("Prevalence and Genetic Diversity Analysis of Human Coronavirus OC43 among Adult Patient with Acute Respiratory Infections in Beijing, 2012", July 2nd, 2014, pages 1-7, PLOS One) as applied to claims 1 and 19, in further view of Raabe & Siddell ("Nucleotide sequence of the gene encoding the membrane protein of human coronavirus 229 E", June 22nd, 1989, pages 323-328, Archives of Virology) and Buck et al. ("Design Strategies and Performance of Custom DNA Sequencing Primers", September, 1999, pages 528-536, BioTechniques).
Karim et al. and Hu et al. fails to teach this method for detection of infectivity of human coronavirus with the specific forward primer 5'- GCTTTACGTTGACGGACATAGA-3' (SEQ ID NO: 5) and a reverse primer 5'- CGGACCTTCCGACTCTACTATAA-3' (SEQ ID NO: 6). However, Raabe & Siddell teaches sequences for HCV 229 E membrane protein gene, NCBI X15498, which comprises SEQ ID NO: 5 and SEQ ID NO: 6 (figure 1).
In addition, Buck et al. exemplify the routine nature of designing primers and probes for sequencing, amplification, and detection of known target sequences. Furthermore, Buck et al. invited primer submissions from a number of labs (39) (software or manual selection of primers section paragraph 1 page 532 lines 1-17), with 69 different primers being submitted (control and submitted primers section paragraph 2 page 530 lines 1-5). Buck et al. also tested 95 primers spaced at 3 nucleotide intervals along the entire sequence at issue, thereby testing more than 1/3 of all possible 18 mer primers on the 300 base pair sequence (control and submitted primers section paragraph 1 page 530 lines 2-14). When Buck tested each of the primers selected by the methods of the different labs, Buck et al. found that EVERY SINGLE PRIMER worked (sequencing performance of the primers section paragraph 1 page 533 lines 1-22). Buck et al. expressly states “The results of the empirical sequencing analysis were surprising in that nearly all the primers yielded data of extremely high quality” (discussion section paragraph 3 page 535 lines 1-4). Therefore, Buck et al. provides direct evidence of the reasonable expectation of success in designing primers to known target sequences.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karim et al. and Hu et al. to incorporate the teachings of Raabe & Siddell to develop a method for detecting the infectivity of a human coronavirus using the specific forward and reverse primers of SEQ ID NO: 5 and SEQ ID NO: 6, with a reasonable expectation of success, as evidenced by the teachings of Buck et al. for routine nature of designing primers and probes for sequencing, amplification, and detection of know target sequences. Doing so would allow for the detection between viable and nonviable human coronavirus to determine which cells are still infectious at the time of sample collection.
Response to Arguments
The response traverses the rejection. The response asserts that neither Karim nor Hu discloses the feature “a power of light is from 85 to 250 mW” as recited in claims 1 & 24 and cannot achieve the advantages of the present application and therefore it would not have been obvious under 35 USC 103 from Karim in view of Hu. Specifically, the response asserts that Karim teaches a power of light used for photo-activation is 800 W light which is higher than the claimed power of light from 85 to 250 mW and that Hu does not disclose dye treatment and photo-activation steps therefore they do not disclose “a power of light is from 85 to 250 mW”. These arguments have been thoroughly reviewed but were not found persuasive. First, it is noted that claims 1 & 24 have been amended to remove intensity and recite power, however, as discussed above it is unclear whether “a power of light is from 85 to 250 mW” is referring to the wattage of power that is emitted from a light source as being from 85 to 250 mW or if it is referring to a wattage of power that is received by the sample is from 85 to 250 mW. Therefore, the claims have been given their broadest reasonable interpretation to encompass the teachings of Karim et al. of 800 W light delivered to a 1.5mL centrifuge tube (pg. 53-54 paragraph bridging pg. 53 & pg. 54 lines 7-13) as disclosing the limitation of “a power of light is from 85 to 250 mW”. Second, 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 have modified Karim et al. to incorporate the teachings of Hu et al. and develop a method for detecting the infectivity of a human coronavirus and for using the specific forward and reverse primer pair as doing so would allow for the detection between viable and nonviable human coronavirus to determine which cells are still infectious at the time of sample collection.
For these reasons, and the reasons already made of record and modified to address the claims as currently amended, the rejections are maintained and applied to the newly amended claims.
Conclusion
Claims 1-9 & 11-24 are rejected.
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 BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET.
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/BAILEY BUCHANAN/Examiner, Art Unit 1682
/JEHANNE S SITTON/Primary Examiner, Art Unit 1682