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 1-8 are pending and under examination.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2 and 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Fujita (US 20070105094).
Current invention directs to a method of isolating viruses from a liquid sample. The principle lies in using characteristic of outer shell phospholipid of virus and trapping with polymer coated magnetic particles where the polymer having affinity of the virus phospholipid (i.e. aggregating agent) followed by masking agent which can enhance homogeneous dispersion of the virus magnetic particle complex and then isolate the virus through magnetism.
Fujita teaches mixing a virus containing liquid sample with magnetic fine particle wherein the magnetic particles having cationic functional group thereon capable of trapping a phospholipid vesicle virus (Title, abstract; section 0018). Fujita further teaches using (1) aggregating agent capable of enhancing forming virus-magnetic particles complex; (2) masking agent enhancing homogeneously dispersing in the liquid solution (section 0018; 0049). The magnetic particles used is water-soluble having hydroxyl group, cationic and with magnetism capability (section 0021). In addition, as to the masking agent, Fujita teaches using poly(meth)acrylic acid as a masking agent having an average molecular weight of 10,000 to 50,000 (section 0021; 0031-0032). The virus can be isolated by the magnetism separation (section 0016-0019; 0059, 0081). However, Fujita does not explicitly teach adding the masking agent to the mixed solution in a concentration range of 0.01-0.1 mass%.
It is noted, in examples of making masking agent, Fujita uses higher molecular weight of “polyacrylic acid 2500” (MW=25000, 250 mg) and “polyacrylic acid 5000”(MW=50000, 250 mg)(section 0180-0181). The mass% for the masking agents is about (250 mg/(99.75g ultra pure water +0.1ml diethy pyrocarbonate))x100%
≅
0.25%. Fujita also teaches using poly(meth)acrylic but this compound is not used in the examples for demonstration (section 0039, 0044).
The current invention uses poly(meth)acrylic acid as the masking agent having a wider molecular weight range for, from 5000-100000 comparing to “polyacrylic acid 2500” (MW=25000)” and “polyacrylic acid 5000”(MW=50000)”. Therefore, before using the current method of isolating viruses from samples, it would have been prima facie obvious to one ordinary skilled person in the art to perform a preliminary test for a new similar masking agent poly(meth)acrylic based on the known similar polyacrylic acid and establish a response range around the mass 0.25% (e.g. 0.01, 0.025, 0.05, 0.1, 0.15, 0.25, 0.5, 1.0, 5.0 %...) for purpose of optimizing the assay. Preliminary optimization is well-known and commonly practiced in the field. One artisan in the field would have been motivated to do so for optimizing the overall assay.
As to claim 2, the method can be used to isolate influenza virus (section 0029).
As to claim 4, the water-soluble cationic magnetic particles containing magnetitie, maghemite, hematitie, or goethite or latex beads (section 0024, 0027, claim 3).
As to claim 5, the average particle size is about 300 nm (section 0022).
As to claim 6, Fujita teaches that the aggregating agent can be a polymer having structure of polyalkylene glycol structure in a main chain, and one of the agents used is polyethylene glycol (section 0034 and 0114).
As to claim 7-8, Fujita also teaches denaturing, dispersing, extracting, amplifying virus and its nucleic acids for further characterization (detection) by PCR (section 0067-0068; 0134).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fujita as applied to claims 1-2 and 4-8 above, and further in view of Pérez-Cataluña (Science of Total Environment 2021 758:143870).
Fujita reference has been discussed above, and the virus scope of Fujita include influenza virus, cytemegalo virus, HIV, papilloma virus, respiratory syncytial virus, poliomyelitis virus, pox virus, measles virus, arbovirus, coxsackievirus, herpes virus, hantavirus, hepatitis virus, Lyme disease virus, mumps virus and rotavirus (section 0029). However Fujita does not explicitly cover isolation and detection of SARS-CoV-2.
Since the outbreak of SARS-Cov-2 at the end of 2019 (COVID-19 pandemic), SARS-Cov-2 has been a focal attention in public and medicine with respect to its detection, treatment and vaccination. Pérez-Cataluña teaches detecting SARS-Cov-2 in wastewater for epidemiology tracking, known as wastewater-based epidemiology (WEB)(page 143871, left column). WEB has been implemented globally for detection SARS-Cov-2 and shed lights into epidemiology study in wastewater, sewers and sludges (page 14371, left column). Pérez-Cataluña also teaches isolating nucleic acid from wastewater samples and detecting SARS-Cov-2 virus (See Materials and Methods, page 2-3).
Therefore, 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 use the methodology of Fujita to isolate and detect SARS-Cov-2 as taught by Pérez-Cataluña in isolating and detecting SARS-Cov-2 virus because of public health concern. One ordinary skilled person in the field would have been motivated to do so because of the importance in epidemiological survey of SARS-Cov-2 and its impact on health as well as commerce. See, e.g., “Conclusions” section of pp. 4-5 of Pérez-Cataluña. The artisan would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Conclusion
No claim is allowed.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678