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 .
Status of Claims
The claim set submitted on 13 MARCH 2026 is acknowledged and considered. In the claim set, Claims 1-4, 9-11, 15, 17 and 18 are ‘Currently Amended’; and Claims 5-8, 12, 13, 14, 16 and 19-20 are ‘Original’.
Current pending claims are Claims 1-20 and are considered on the merits below.
Response to Amendment/Arguments
In response to the 101 rejection, the Examiner has amended the rejection to reflect the amendment to the claims and what is considered to be eligible subject matter. See below.
Applicant's arguments filed 13 MARCH 2026 have been fully considered but they are not persuasive.
In response to Applicant’s assertion that Bidra is not prior art; Examiner respectfully disagrees. In fact, the Bidra reference was published on 08 JUNE 2020, which is prior to the EFD of 10 JUNE 2020.
See attached screen shot. The Bidra reference qualifies as prior art.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claims 1 and 18, the claimed invention are directed to an abstract idea without significantly more for the reasons discussed below (see Subject Matter Eligibility Test in MPEP 2106):
Eligibility Step 1: Claims 1 and 18 are directed to a process.
Eligibility Step 2A, Prong 1: Claims 1 and 18 recite the abstract ideas of: (i) evaluating results of the testing to determine whether the at least one proposed disinfectant is suitable for a pre-selected environment, the evaluating including an evaluation of the pre-selected contact time period or the pre-selected rinsing time period determined from the testing of the at least one proposed disinfectant (evaluating results of the testing to determine whether the at least one proposed disinfectant is suitable for a pre-selected environment is an observation or evaluation that can be practically performed in the human mind and or pen/paper); and (ii) selecting the proposed disinfectant based on the evaluating of the results of the testing for use in a cleaning operation and/or a rinsing operation (selecting the proposed disinfectant based on the evaluating of the results of the testing is an observation or evaluation that can be practically performed in the human mind and or pen/paper). See MPEP 2106.04(a)(2)(III)(B).
Eligibility Step 2A, Prong 2: The judicial exception is not integrated into a practical application. Other than the abstract ideas, claims 1 and 18 recite a step of testing and performing a cleaning/rinsing step. The testing step is mere data gathering and hence insignificant extra-solution activity (see MPEP 2106.05(g)) and the cleaning/rinsing step is a step that is considered to be well understood routine and conventional. Furthermore, once the selecting step is completed in claims 1 and 18, nothing further is done with the abstract ideas. Thus, there is no application of the abstract idea much less a practical particular application. Any additional steps which transforms the claim into something that integrates the abstract idea into a practical application of the abstract idea is not presented in the amended claims and these additional steps are broadly recited insignificant extra solution activities and when viewed as a whole; these additional steps do not impart any significance to the abstract idea.
Eligibility Step 2B: Claims 1 and 18 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Other than the abstract ideas, claims 1 and 18 recites a step of testing and a rinsing/cleaning step. As discussed above, the testing step is insignificant extra-solution activity and the cleaning step is a step well understood routine and conventional; as see in the rejection below. Furthermore, the testing step is a well understood, routine and conventional activity within the prior art (see Rabenau and Bidra as applied to claims 1 and 18 below).
Dependent claims 2-3 do not resolve any of the issues discussed above because they involve insignificant extra-solution activity and/or well understood, routine and conventional activities within the prior art and does not include any additional steps which transforms the claim into something that integrates the abstract idea into a practical application of the abstract idea.
Dependent claims 4 and 5 recites additional steps which are merely data gathering steps and are insufficient to amount to a practical application of the judicial exception, MPEP 2106.05(g).
Dependent claims 6-14 do not resolve any of the issues discussed above because they involve insignificant extra-solution activity and/or well understood, routine and conventional activities within the prior art.
Dependent claims 15-17 and 19-20 are do not resolve any of the issues discussed above because they do not include any include any subject matter which includes subject matter or any additional steps which transforms the claim into something that integrates the abstract idea into a practical application of the abstract idea.
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 1-2, 9-10, 12-14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bidra et al. (Bidra, Avinash S., et al. “Rapid in‐vitro inactivation of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) using povidone‐iodine oral antiseptic rinse.” Journal of Prosthodontics 29.6 (2020): 529-533; hereinafter “Bidra”).
Regarding claim 1, Bidra discloses a process for reducing human coronavirus transmission and/or spread (mitigate the risk and transmission of SARS-CoV-2; p. 529, paragraphs under Abstract), the process comprising:
testing at least one proposed disinfectant (wherein the oral preparations of povidone-iodine (PVP-I) are interpreted as the proposed disinfectants; p. 530, 1st paragraph under Materials and methods header, and p. 531, Tables 1-2) to determine a pre-selected contact time period or pre-selected rinsing time period (incubated at room temperature for time periods of 15 and 30 seconds which are interpreted as pre-selected contact time periods; p. 530, 2nd paragraph under Materials and methods header, and p. 531, Tables 1-2) for each proposed disinfectant to decrease an amount of infectious human coronavirus by at least 90% (the optimal contact time and concentration are investigated for viricidal activity of oral preparations of PVP-I against SARS-CoV-2 to mitigate the risk and transmission of the virus, such as a log10 reduction greater than 3, which is interpreted as reducing infectious human coronavirus by at least 90%; p. 529, paragraphs under Abstract header, p. 531, paragraph under Results header, and p. 531 Tables 1-2);
evaluating results of the testing to determine whether the at least one proposed disinfectant is suitable for a pre-selected environment (the results of the testing were evaluated to determine whether the disinfectants were suitable in a mixture with a virus solution which is interpreted as the pre-selected environment; p. 530, 2nd-3rd paragraphs under Materials and methods header), the evaluating including an evaluation of the pre-selected contact time period or the pre-selected rinsing time period determined from the testing of the at least one proposed disinfectant (wherein the evaluating includes an evaluation of time periods of 15 and 30 seconds from testing the disinfectants in the mixture with a virus solution; p. 529, paragraphs under Abstract header, p. 531, paragraph under Results header, and p. 531, Tables 1-2);
selecting the proposed disinfectant based on the evaluating of the results of the testing for use in 10 reduction greater than 3, and are thus interpreted as being selected, based on the evaluation of the testing for use in a rinsing operation; p. 529, paragraphs under Abstract header, p. 531, paragraph under Results header, and p. 531, Tables 1-2); and
performing the rinsing operation (the disinfectants, e.g., oral preparations of PVP-I, are used in preprocedural oral rinsing for patients and health care providers, which is interpreted as the rinsing operation; p. 532, paragraph under Conclusions header), the rinsing operation comprising retaining a solution that includes the disinfectant (oral preparations of PVP-I are interpreted as the solution that includes the disinfectant; 1st paragraph under Materials and methods header, and p. 531, Tables 1-2) in a mouth of a user for the pre-selected rinsing time period (the disinfectants, e.g., oral preparations of PVP-I, are used in preprocedural oral rinsing for patients and health care providers at the lowest concentration of 0.5 %, and at the lowest contact time of 15 seconds, which is interpreted as the pre-selected rinse time; p. 532, paragraph under Conclusions header).
Bidra discloses the claimed method, but is silent in regards to wherein the infectious human coronavirus comprising COVID-19.
However, it is known in the art that SARS‑CoV‑2 is the virus, while COVID‑19 is the disease it causes. SARS‑CoV‑2 (Severe Acute Respiratory Syndrome Coronavirus 2) is the pathogen identified in 2019, and COVID‑19 (Coronavirus Disease 2019) is the illness that results from infection by this virus.
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the method of Bidra such that the characterization of the infectious human coronavirus comprising COVID-19 since SARS-CoV-2 infects human cells and triggers the immune response that produces the symptoms known as COVID-19.
Regarding claim 2, Bidra discloses the process of claim 1 as discussed above. Bidra disclose the process comprising: performing a cleaning operation using the selected disinfectant, (the disinfectants, e.g., oral preparations of PVP-I, are used in preprocedural oral rinsing for patients and health care providers, which is interpreted as the rinsing operation; p. 532, paragraph under Conclusions header).
Regarding claim 9, Bidra discloses the process of claim 1 as discussed above. Bidra further discloses wherein the testing of the at least one proposed disinfectant is performed to determine 10 reduction greater than 3, and are thus interpreted as decreasing the amount of infectious human coronavirus by at least 99%; p. 529, paragraphs under Abstract header, p. 531, paragraph under Results header, and p. 531, Tables 1-2).
Regarding claim 10, Bidra discloses the process of claim 1 as discussed above. Bidra further discloses wherein the testing of the at least one proposed disinfectant is performed to determine 10 reduction greater than 3, and are thus interpreted as decreasing the amount of infectious human coronavirus by at least 99.9%; p. 529, paragraphed under Abstract header, p. 531, paragraph under Results header, and p. 531, Tables 1-2).
Regarding claim 12, Bidra discloses the process of claim 1 as discussed above. Bidra further discloses wherein the at least one proposed disinfectant include a plurality of disinfectants (wherein the oral preparations of PVP-I and the preparation of ethanol are interpreted as the plurality of disinfectants; p. 530, 1st paragraph under Materials and methods header, and p. 531, Tables 1-2).
Regarding claim 13, Bidra discloses the process of claim 12 as discussed above. Bidra further discloses wherein the disinfectants are selected from the group consisting of an ethanol solution, a 70% ethanol solution, a 95% ethanol solution, a glutaraldehyde (GTA) solution, a 2.4% GTA solution, a 3.4% GTA solution, an ortho-phthalaldehyde (OPA) solution, a 0.55% OPA solution, a phenol solution, a paracetic acid-silver (PAA-silver) solution, a 0.25% PAA-silver solution, a 1.2% PAA-silver solution, a hypochlorite solution, and a 0.525% hypochlorite solution, diluted shampoo, diluted baby shampoo, a saline rinse, bromelain, a solution or substance that includes a protein-digesting enzyme mixture derived from the stem, fruit, and juice of the pineapple plant, a solution that includes verbena, common sorrel, elder flower, primula flower and gentain root, an antiseptic oral rinse, and an oral rinse (wherein the oral preparations of PVP-I are an oral rinse and the ethanol solution is a 70% ethanol solution; p. 530, 1st paragraph under Materials and methods header, and p. 531, Tables 1-2).
Regarding claim 14, Bidra discloses the process of claim 1 as discussed above. Bidra further discloses wherein the disinfectants are selected from the group consisting of an ethanol solution, a 70% ethanol solution, a 95% ethanol solution, a glutaraldehyde (GTA) solution, a 2.4% GTA solution, a 3.4% GTA solution, an ortho-phthalaldehyde (OPA) solution, a 0.55% OPA solution, a phenol solution, a paracetic acid-silver (PAA-silver) solution, a 0.25% PAA-silver solution, a 1.2% PAA-silver solution, a hypochlorite solution, and a 0.525% hypochlorite solution, diluted shampoo, diluted baby shampoo, a saline rinse, bromelain, a solution or substance that includes a protein-digesting enzyme mixture derived from the stem, fruit, and juice of the pineapple plant, a solution that includes verbena, common sorrel, elder flower, primula flower and gentain root, an antiseptic oral rinse, and an oral rinse (wherein the oral preparations of PVP-I are an oral rinse and the ethanol solution is a 70% ethanol solution; p. 530, 1st paragraph under Materials and methods header, and p. 531, Tables 1-2).
Regarding claim 17, Bidra discloses the process of claim 14 as discussed above. Bidra further discloses wherein the testing of the at least one proposed disinfectant is performed to determine the pre-selected contact time period and the preselected rinsing time period for each proposed disinfectant to decrease the amount of infectious human coronavirus by at least 99%, (wherein the disinfectants were shown to be effective in a log10 reduction greater than 3, and are thus interpreted as decreasing the amount of infectious human coronavirus by at least 99%; p. 529, paragraphs under Abstract header, p. 531, paragraph under Results header, and p. 531, Tables 1-2, see column of Incubation Time).
Claims 1, 2, 5, 6 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rabenau et al. (Rabenau, H. F., et al. “Stability and inactivation of SARS coronavirus.” Medical microbiology and immunology 194.1 (2005): 1-6; hereinafter “Rabenau”) and further in view of Bidra et al. (Bidra, Avinash S., et al. “Rapid in‐vitro inactivation of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) using povidone‐iodine oral antiseptic rinse.” Journal of Prosthodontics 29.6 (2020): 529-533; hereinafter “Bidra”).
Regarding claim 1, Rabenau discloses a process for reducing human coronavirus transmission and/or spread (see p.1, paragraph under Abstract heading), the process comprising:
testing at least one proposed disinfectant (wherein 2-propanol, Desderman N, Sterillium, formaldehyde and glutardialdehyde, Incidin plus, wine vinegar are interpreted as the proposed disinfectants; p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading) to determine a pre-selected contact time period or pre-selected rinsing time period (wherein the disinfectants are in a mixture with a viral suspension and minimum essential medium (MEM) or fetal calf serum (FCS) and incubated for defined periods of time, which are interpreted as pre-selected contact time periods, at room temperature; p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading) for each proposed disinfectant to decrease an amount of infectious human coronavirus by at least 90% (each of the chemical disinfectants were tested to determine a pre-selected contact time to render SARS-CoV non-infectious, which is interpreted as reducing infectious human coronavirus by at least 90% - further support for reducing infectious human coronavirus by at least 90% is shown in Table 2 that lists a log10 reduction greater than 1 for the disinfectants; p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading, and p. 4, right column, ¶ 2, and p. 4, Table 2);
evaluating results of the testing to determine whether the at least one proposed disinfectant is suitable for a pre-selected environment (the results of the testing were evaluated to determine whether the disinfectants were suitable in a mixture with a viral suspension and minimum essential medium (MEM) or fetal calf serum (FCS) which are collectively interpreted as the pre-selected environment; p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading, p. 4, right column, ¶ 2, Table 2), the evaluating including an evaluation of the pre-selected contact time period or the pre-selected rinsing time period determined from the testing of the at least one proposed disinfectant (wherein the evaluating includes an evaluation of the defined periods of time from testing the disinfectants in a mixture with a viral suspension and minimum essential medium (MEM) or fetal calf serum (FCS); p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading, p. 4, right column, ¶ 2, Table 2);
selecting the proposed disinfectant based on the evaluating of the results of the testing for use in a cleaning operation (the disinfectants were shown to render SARS-CoV non-infectious, and are thus interpreted as being selected, based on the evaluation of the testing for use in SARS-CoV inactivation for improving laboratory safety, which is interpreted as a cleaning operation; p. 2, left column, ¶ 1, p. 4, left column, ¶ 2, and p. 5, left column, ¶¶ 2 and 6; It is interpreted that a the use of detergents is considered to be a form of rinsing which leaves it free of residues).
Rabenau discloses the claimed invention, but is silent in regards to wherein the method include performing a rinsing operation, the rising operation comprising retaining a solution that includes the selected proposed disinfectant in a mouth of a user for the pre- selected rinsing time period.
Bidra discloses a process for reducing human coronavirus transmission and/or spread (mitigate the risk and transmission of SARS-CoV-2; p. 529, paragraphs under Abstract), the process comprising:
testing at least one proposed disinfectant (wherein the oral preparations of povidone-iodine (PVP-I) are interpreted as the proposed disinfectants; p. 530, 1st paragraph under Materials and methods header, and p. 531, Tables 1-2) to determine a pre-selected contact time period or pre-selected rinsing time period (incubated at room temperature for time periods of 15 and 30 seconds which are interpreted as pre-selected contact time periods; p. 530, 2nd paragraph under Materials and methods header, and p. 531, Tables 1-2) for each proposed disinfectant to decrease an amount of infectious human coronavirus by at least 90% (the optimal contact time and concentration are investigated for viricidal activity of oral preparations of PVP-I against SARS-CoV-2 to mitigate the risk and transmission of the virus, such as a log10 reduction greater than 3, which is interpreted as reducing infectious human coronavirus by at least 90%; p. 529, paragraphs under Abstract header, p. 531, paragraph under Results header, and p. 531 Tables 1-2);
evaluating results of the testing to determine whether the at least one proposed disinfectant is suitable for a pre-selected environment (the results of the testing were evaluated to determine whether the disinfectants were suitable in a mixture with a virus solution which is interpreted as the pre-selected environment; p. 530, 2nd-3rd paragraphs under Materials and methods header), the evaluating including an evaluation of the pre-selected contact time period or the pre-selected rinsing time period determined from the testing of the at least one proposed disinfectant (wherein the evaluating includes an evaluation of time periods of 15 and 30 seconds from testing the disinfectants in the mixture with a virus solution; p. 529, paragraphs under Abstract header, p. 531, paragraph under Results header, and p. 531, Tables 1-2);
selecting the proposed disinfectant based on the evaluating of the results of the testing for use in 10 reduction greater than 3, and are thus interpreted as being selected, based on the evaluation of the testing for use in a rinsing operation; p. 529, paragraphs under Abstract header, p. 531, paragraph under Results header, and p. 531, Tables 1-2); and
performing the rinsing operation (the disinfectants, e.g., oral preparations of PVP-I, are used in preprocedural oral rinsing for patients and health care providers, which is interpreted as the rinsing operation; p. 532, paragraph under Conclusions header), the rinsing operation comprising retaining a solution that includes the disinfectant (oral preparations of PVP-I are interpreted as the solution that includes the disinfectant; 1st paragraph under Materials and methods header, and p. 531, Tables 1-2) in a mouth of a user for the pre-selected rinsing time period (the disinfectants, e.g., oral preparations of PVP-I, are used in preprocedural oral rinsing for patients and health care providers at the lowest concentration of 0.5 %, and at the lowest contact time of 15 seconds, which is interpreted as the pre-selected rinse time; p. 532, paragraph under Conclusions header).
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the Rabenau to include the performing the rinsing operation, the rising operation comprising retaining a solution that includes the selected proposed disinfectant in a mouth of a user for the pre- selected rinsing time period as taught by Bidra to have the mouth free of any residues of the disease.
Bidra discloses the claimed method, but is silent in regards to wherein the infectious human coronavirus comprising COVID-19.
However, it is known in the art that SARS‑CoV‑2 is the virus, while COVID‑19 is the disease it causes. SARS‑CoV‑2 (Severe Acute Respiratory Syndrome Coronavirus 2) is the pathogen identified in 2019, and COVID‑19 (Coronavirus Disease 2019) is the illness that results from infection by this virus.
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the method of Bidra such that the characterization of the infectious human coronavirus comprising COVID-19 since SARS-CoV-2 infects human cells and triggers the immune response that produces the symptoms known as COVID-19.
Regarding claim 2, Rabenau in view of Bidra discloses the process of claim 1 as discussed above. Bidra disclose the process comprising: performing a cleaning operation using the selected disinfectant, (the disinfectants, e.g., oral preparations of PVP-I, are used in preprocedural oral rinsing for patients and health care providers, which is interpreted as the rinsing operation; p. 532, paragraph under Conclusions header).
Regarding claim 5, Rabenau in view of Bidra discloses the process of claim 1 as discussed above. Rabenau further discloses wherein the testing includes:
adding bovine serum albumin (BSA) to a virus suspension (fetal calf serum (FCS), which contains BSA, is added to a virus suspension; p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading) that also includes a rinse solution comprising a first disinfectant of the at least one proposed disinfectant (wine vinegar that could be used as a spray for inhalation and therefore is interpreted as the rinse solution comprising the first disinfectant; p. 3, left column, ¶ 3) to form a mixture (see p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading);
incubating the mixture for at least one contact time period (the mixture is incubated for defined periods of time; p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading), the contact time period being at least 20 seconds and not more than 5 minutes (wherein the contact time periods for the wine vinegar is 60 seconds; p. 4, Table 2); and
assaying viral samples that were formed from the mixture for infectivity (virus titres are assessed; p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading; p. 4, right column, ¶ 2, and p. 4, Table 2).
Regarding claim 6, Rabenau in view of Bidra discloses the process of claim 5 as discussed above. Rabenau further discloses wherein the assaying utilizes a TCID50 assay procedure (infectious virus titres were determined as 50% tissue culture infective doses (TCID50) in confluent cells in 96-well microtitre plates; p. 2, paragraph under Viruses and cells subheader, p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheader, and p. 4, Table 2).
Regarding claim 9, Rabenau in view of Bidra discloses the process of claim 1 as discussed above. Rabenau further discloses wherein the testing of the at least one proposed disinfectant is performed to determine 10 reduction greater than 2; p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading, p. 4, right column, ¶ 2, and p. 4, Table 2).
Regarding claim 10, Rabenau in view of Bidra discloses the process of claim 1 as discussed above. Rabenau further discloses wherein the testing of the at least one proposed disinfectant is performed to determine 10 reduction greater than 3; p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading, p. 4, right column, ¶ 2, and p. 4, Table 2).
Regarding claim 11, Rabenau in view of Bidra discloses the process of claim 1 as discussed above. Rabenau further discloses wherein the testing of the at least one proposed disinfectant is performed to determine rinsing time period for each proposed disinfectant to decrease the amount of infectious human coronavirus by at least 99.99% (each of the chemical disinfectants were tested to determine a pre-selected rinsing time to render SARS-CoV non-infectious, which is interpreted as reducing infectious human coronavirus by at least 99.99% - further support for reducing infectious human coronavirus by at least 99.99% is shown in Table 2 that lists several disinfectants having a log10 reduction greater than 4; p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading, p. 4, right column, ¶ 2, and p. 4, Table 2).
Regarding claim 12, Rabenau in view of Bidra discloses the process of claim 1 as discussed above. Rabenau further discloses wherein the at least one proposed disinfectant include a plurality of disinfectants (wherein 2-propanol, Desderman N, Sterillium, formaldehyde and glutardialdehyde, Incidin plus, wine vinegar are interpreted as a plurality of disinfectants; p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading).
Regarding claim 13, Rabenau in view of Bidra discloses the process of claim 12 as discussed above. Rabenau further discloses wherein the disinfectants are selected from the group consisting of an ethanol solution, a 70% ethanol solution, a 95% ethanol solution, a glutaraldehyde (GTA) solution, a 2.4% GTA solution, a 3.4% GTA solution, an ortho-phthalaldehyde (OPA) solution, a 0.55% OPA solution, a phenol solution, a paracetic acid-silver (PAA-silver) solution, a 0.25% PAA-silver solution, a 1.2% PAA-silver solution, a hypochlorite solution, and a 0.525% hypochlorite solution, diluted shampoo, diluted baby shampoo, a saline rinse, bromelain, a solution or substance that includes a protein-digesting enzyme mixture derived from the stem, fruit, and juice of the pineapple plant, a solution that includes verbena, common sorrel, elder flower, primula flower and gentain root, an antiseptic oral rinse, and an oral rinse (wherein Desderman N is an ethanol solution; p. 3, 1st paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading).
Regarding claim 14, Rabenau in view of Bidra discloses the process of claim 1 as discussed above. Rabenau further discloses wherein the at least one proposed disinfectant includes at least one of: an ethanol solution, a 70% ethanol solution, a 95% ethanol solution, a glutaraldehyde (GTA) solution, a 2.4% GTA solution, a 3.4% GTA solution, an ortho-phthalaldehyde (OPA) solution, a 0.55% OPA solution, a phenol solution, a paracetic acid-silver (PAA-silver) solution, a 0.25% PAA-silver solution, a 1.2% PAA-silver solution, a hypochlorite solution, a saline solution, a solution or substance that includes a protein-digesting enzyme mixture derived from the stem, fruit, and juice of the pineapple plant, and a 0.525% hypochlorite solution (wherein Desderman N is an ethanol solution; p. 3, 1st paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading).
Claims 3-4, 15-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rabenau in view of Bidra and further in view of Chen (Chen, Tina. “Reducing COVID-19 transmission through cleaning and disinfecting household surfaces.” Vancouver, BC: National Collaborating Centre for Environmental Health (2020): 1-18).
Regarding claim 3, Rabenau in view of Bidra discloses the process of claim 1 as discussed above. Rabenau discloses a cleaning operation that comprises contacting a solution that includes the selected proposed disinfectant on a surface for the pre-selected contact time period (the disinfectants, e.g., Desderman N, Sterillium, etc., which are solutions that include a disinfectant, render SARS-CoV non-infectious for use in SARS-CoV inactivation for improving laboratory safety, which is interpreted as a cleaning operation whereby the disinfectant would be applied to a surface for the pre-selected contact time period; p. 2, left column, ¶ 1, p. 4, left column, ¶ 2, and p. 5, left column, ¶¶ 2 and 6). However, Rabenau does not explicitly disclose performing a cleaning operation comprising contacting a solution that includes the disinfectant on a surface within a room of a building for the pre-selected contact time period.
Chen, in the same art of reducing human coronavirus transmission, teaches cleaning and disinfecting to reduce viability of human coronavirus on potentially contaminated surfaces (see p. 1, 2nd paragraph under Background header). Chen further teaches a cleaning operation comprising contacting a solution that includes a disinfectant (see pp. 3-5, paragraphs under Sanitizers subheader and Disinfectants subheader) on a surface (interpreted as a household surface; p. 2, 1st paragraph under Types of Household Surfaces header, and p. 2, Table 1) within a room of a building (see the cleaning operations of household surfaces, such as door handles, light switches, toilet seats, etc., taught by Rabenau as modified by Chen above are interpreted as cleaning operations within a room of the building; Chen, p. 2, 1st paragraph under Types of Household Surfaces header, p. 2, Table 1, and p. 6, paragraphs under Frequency of cleaning, sanitizing, and disinfecting surfaces header).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cleaning operation of Rabenau to perform a step of cleaning on a surface within a room of a building as taught by Chen for the benefit of reducing the viability of the virus on potentially contaminated surfaces (see Chen, p. 1, 2nd paragraph under Background header).
Regarding claim 4, Rabenau in view of Bidra in view of Chen discloses the process of claim 3 as discussed above. Rabenau further discloses wherein the testing includes:
adding bovine serum albumin (BSA) to a virus suspension (fetal calf serum (FCS), which contains BSA, is added to a virus suspension; p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading) that also includes a rinse solution comprising a first disinfectant of the at least one proposed disinfectant (wine vinegar that could be used as a spray for inhalation and therefore is interpreted as the rinse solution comprising the first disinfectant; p. 3, left column, ¶ 3) to form a mixture (see p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading);
incubating the mixture for at least one contact time period (the mixture is incubated for defined periods of time; p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading), the contact time period being at least 20 seconds and not more than 5 minutes (wherein the contact time periods for the wine vinegar is 60 seconds; p. 4, Table 2); and
assaying viral samples that were formed from the mixture for infectivity (virus titres are assessed; p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading; p. 4, right column, ¶ 2, and p. 4, Table 2).
Regarding claim 15, Rabenau in view of Bidra discloses the process of claim 14 as discussed above. Chen, in the same art of reducing human coronavirus transmission, teaches cleaning and disinfecting to reduce viability of human coronavirus on potentially contaminated surfaces (see p. 1, 2nd paragraph under Background header). Chen further teaches performing the cleaning operation, the cleaning operation comprising contacting a solution that includes the selected proposed disinfectant on a surface within a room of a building for a pre-selected contact time period. (the cleaning operations of household surfaces, such as door handles, light switches, toilet seats, etc., taught by Rabenau as modified by Chen above are interpreted as cleaning operations within a room of the building; Chen, p. 2, 1st paragraph under Types of Household Surfaces header, p. 2, Table 1, and p. 6, paragraphs under Frequency of cleaning, sanitizing, and disinfecting surfaces header).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cleaning operation of Rabenau in view of Bidra to perform the cleaning operation, the cleaning operation comprising contacting a solution that includes the selected proposed disinfectant on a surface within a room of a building for apre-selected contact time period for the benefit of reducing the viability of the virus on potentially contaminated surfaces (see Chen, p. 1, 2nd paragraph under Background header).
Regarding claim 16, the combination of Rabenau, Bidra and Chen teaches the process of claim 15 as discussed above. Rabenau in view of Chen further teaches wherein the surface is a floor, a counter, a tabletop, a desktop, or a work surface (the cleaning operations of household surfaces taught by Rabenau as modified by Chen above comprises surfaces, such as floors and counters; Chen, p. 2, 1st paragraph under Types of Household Surfaces header, and p. 2, Table 1).
Regarding claim 18, Rabenau discloses a process for reducing human coronavirus transmission and/or spread, (see p.1, paragraph under Abstract heading), the process comprising:
testing a plurality of proposed disinfectants, (wherein 2-propanol, Desderman N, Sterillium, formaldehyde and glutardialdehyde, Incidin plus, wine vinegar are interpreted as the proposed disinfectants; p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading) to determine a pre-selected contact time period and a pre-selected rinsing time period (wherein the disinfectants are in a mixture with a viral suspension and minimum essential medium (MEM) or fetal calf serum (FCS) and incubated for defined periods of time, which are interpreted as pre-selected contact time periods, at room temperature; p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading) for each of the proposed disinfectants to decrease an amount of infectious human coronavirus by at least 90%, (each of the chemical disinfectants were tested to determine a pre-selected contact time to render SARS-CoV non-infectious, which is interpreted as reducing infectious human coronavirus by at least 90% - further support for reducing infectious human coronavirus by at least 90% is shown in Table 2 that lists a log10 reduction greater than 1 for the disinfectants; p. 3, paragraphs under Susceptibility of SARS-CoV to different chemical disinfectants subheading, and p. 4, right column, ¶ 2, and p. 4, Table 2);
evaluating results of the testing to determine whether at least one of the proposed disinfectants is suitable for a pre-selected environment, (the results of the testing were evaluated to determine whether the disinfectants were suitable in a mixture with a viral suspension and minimum essential medium (MEM) or fetal calf serum (FCS) which are collectively interpreted as the pre-selected environment; p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading, p. 4, right column, ¶ 2, Table 2), the evaluating including an evaluation of the pre-selected contact time period and the pre-selected rinsing time period determined from the testing of the proposed disinfectants (wherein the evaluating includes an evaluation of the defined periods of time from testing the disinfectants in a mixture with a viral suspension and minimum essential medium (MEM) or fetal calf serum (FCS); p. 3, 2nd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading, p. 4, right column, ¶ 2, Table 2);
selecting a first proposed disinfectant of the proposed disinfectants based on the evaluating of the results of the testing for use in a cleaning operation and selecting a second proposed disinfectant of the proposed disinfectants based on the evaluating of the results of the testing for use in a rinsing operation, (the disinfectants were shown to render SARS-CoV non-infectious, and are thus interpreted as being selected, based on the evaluation of the testing for use in SARS-CoV inactivation for improving laboratory safety, which is interpreted as a cleaning operation; p. 2, left column, ¶ 1, p. 4, left column, ¶ 2, and p. 5, left column, ¶¶ 2 and 6);
performing the cleaning operation, the cleaning operation comprising contacting a solution that include a first disinfectant on a surface (the disinfectants were shown to render SARS-CoV non-infectious for improving laboratory safety, which is interpreted as selecting the first disinfectant for the cleaning operation; p. 2, left column, ¶ 1, p. 4, left column, ¶ 2, and p. 5, left column, ¶¶ 2 and 6); and
The Rabenau reference does not explicitly teach selecting a second disinfectant for the rinsing operation, and performing the rinsing operation, the rinsing operation comprising retaining a solution that includes the second disinfectant in a mouth of a user for the pre-selected rinsing time period.
Bidra, in the same art of reducing human coronavirus transmission, further teaches selecting a disinfectant for a rinsing operation (the disinfectants were shown to be effective in a log10 reduction greater than 3 based on the evaluation of the testing for use in a rinsing operation, and are thus interpreted as being selected for the rinsing operation; p. 529, paragraphs under Abstract header, p. 531, paragraph under Results header, and p. 531, Tables 1-2), and performing the rinsing operation (the disinfectants, e.g., oral preparations of PVP-I, are used in preprocedural oral rinsing for patients and health care providers, which is interpreted as the rinsing operation; p. 532, paragraph under Conclusions header), the rinsing operation comprising retaining a solution that includes the disinfectant (oral preparations of PVP-I are interpreted as the solution that includes the disinfectant; p. 530, right column, ¶ 3 and Tables 1-2) in a mouth of a user for the pre-selected rinsing time period (the disinfectants, e.g., oral preparations of PVP-I, are used in preprocedural oral rinsing for patients and health care providers at the lowest concentration of 0.5 %, and at the lowest contact time of 15 seconds, which is interpreted as the pre-selected rinse time; p. 532, paragraph under Conclusions header).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Rabenau to incorporate selecting a disinfectant for a rinsing operation and performing the rinsing operation as taught by Bidra for the benefit of mitigating the risk and transmission of the virus in the dental practice (see Bidra, p. 529, paragraphs under Abstract header).
Chen, in the same art of reducing human coronavirus transmission, teaches cleaning and disinfecting to reduce viability of human coronavirus on potentially contaminated surfaces (see p. 1, 2nd paragraph under Background header). Chen further teaches a cleaning operation comprising contacting a solution that includes a disinfectant (see pp. 3-5, paragraphs under Sanitizers subheader and Disinfectants subheader) on a surface (interpreted as a household surface; p. 2, 1st paragraph under Types of Household Surfaces header, and p. 2, Table 1) within a building (see p. 6, paragraphs under Frequency of cleaning, sanitizing, and disinfecting surfaces header).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cleaning operation of Rabenau to perform a step of cleaning on a surface within a building as taught by Chen for the benefit of reducing the viability of the virus on potentially contaminated surfaces (see Chen, p. 1, 2nd paragraph under Background header).
Regarding claim 19, the combination of Rabenau, Chen, and Bidra teaches the process of claim 18 as discussed above. Rabenau in view of Chen and Bidra further teaches wherein the surface is a floor, a counter, a tabletop, a desktop, or a work surface (the cleaning operations of household surfaces taught by Rabenau as modified by Chen above comprises surfaces, such as floors and counters; Chen, p. 2, 1st paragraph under Types of Household Surfaces header, and p. 2, Table 1).
Regarding claim 20, the combination of Rabenau, Bidra and Chen, teaches the process of claim 19 as discussed above. Rabenau in view of Chen and Bidra further teaches wherein the performing of the rinsing operation also includes spitting out the solution that includes the second disinfectant after the pre-selected rinsing time period has passed (wherein oral preparation of povidone-iodine (PVP-I) are used as a gargle/mouthwash and are interpreted as being spit out by a patient after the pre-selected rinsing time period; Bidra, p. 529, paragraphs under Abstract header, and p. 532, References, #10).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rabenau in view of Bidra and further in view of Darnell et al. (Darnell, Miriam ER, et al. “Inactivation of the coronavirus that induces severe acute respiratory syndrome, SARS-CoV.” Journal of virological methods 121.1 (2004): 85-91; hereinafter “Darnell”).
Regarding claim 7, Rabenau in view of Bidra discloses the process of claim 5 as discussed above. Rabenau further discloses wherein the viral samples are formed by adding a portion of the mixture to a centrifugal filter (the virus-disinfectant mixture was membrane-filtered after incubation using Amicon Ultra4 Filter units 100 kDa, which is interpreted as the centrifugal filter; p. 3, 3rd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading) and subsequently centrifuging the viral samples at a pre-selected speed of rotation for a pre-selected centrifuging time period (wherein the virus-disinfectant mixture was membrane-filtered using Amicon Ultra4 Filter units 100 kDa, which are centrifugal filter devices that involve centrifuging to provide ultrafiltration, and therefore the virus-disinfectant mixture is interpreted as being subsequently centrifuged at a pre-selected speed of rotation for a pre-selected centrifuging time period; p. 3, 3rd paragraph under Susceptibility of SARS-CoV to different chemical disinfectants subheading).
However, Rabenau does not explicitly disclose adding a neutralizer to the filter. Darnell, in same art of reducing human coronavirus transmission, teaches adding a neutralizer prior to analyzing virus aliquots for viral titer using the TCID50 assay. (see p. 87, § 2.7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Rabenau to add a neutralizer as taught by Darnell to Rabenau’s filter for the benefit of reducing the interference of pH in the TCID50 assay.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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