DETAILED ACTION
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 the Claims
The amendment to the claims filed 2 January 2024 has been entered. Claims 1-26 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2 January 2024 was filed before the mailing of an Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 5-11 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.
Instant claims 5-11 are drawn to a method of using the biocidal agent of claim 1, comprising using the biocidal agent for a purpose. The term “using” is not an active step in a method, and it is unclear how the composition is used. It is recommended that Applicant amend claims 5-6 to be drawn to a method of inhibiting infection, controlling infection, etc. comprising an active step such as contacting, applying, etc. The examiner recommends Applicant amend claim 7 to be drawn to a method of coating a surface of a material, and recites the active step of applying the biocidal agent of claim 1 to a surface of materials.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 12 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Palomo Carmona et al. (WO 2020/239673 A1).
Regarding instant claim 1, Palomo Carmona et al. disclose a hybrid material comprising: a protein matrix comprising lipase B from Candida antarctica and nanoparticles of copper species selected from: Cu(0), Cu2O Cu3(PO4)2 or any combination thereof, wherein the nanoparticles have an average diameter between 3 and 15 nm and are homogeneously distributed within the matrix (Claim 1).
Regarding instant claim 2, Palomo Carmona et al. disclose a protein matrix comprising lipase B from Candida antarctica (Claim 1).
Regarding instant claim 3, Palomo Carmona et al. disclose nanoparticles of copper species Cu3(PO4)2, wherein the nanoparticles have an average diameter between 3 and 15 nm (Claim 1).
Regarding instant claim 4, Palomo Carmona et al. disclose that in the case the copper species obtained is Cu3(PO4)2, The nanoparticles are of around 3-5 nm size (pg. 8, ln. 17-18; pg. 19, ln. 19-22).
Regarding instant claim 12, Palomo Carmona et al. disclose a solution comprising Cu-CALB-PHOS2 biohybrid in the presence of hydrogen peroxide (pg. 24, ln. 4-8).
The applied reference has a common assignee and inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claims 1-4 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Losada-Garcia et al. (Nanomaterials, published 18 December 2019).
Regarding instant claim 1, Losada-Garcia et al. disclose Cu nanoparticles embedded on a protein matrix (pg. 2; Figure 1). The Cu nanoparticles include Cu3(PO4)2, Cu2O and Cu (0), and the protein matrix comprises lipase B from Candida antarctica (CAL-B) (pg. 2-5).
Regarding instant claim 2, Losada-Garcia et al. disclose a protein matrix comprising lipase B from Candida antarctica (pg. 2).
Regarding instant claim 3, Losada-Garcia et al. disclose nanoparticles of copper species Cu3(PO4)2, wherein the nanoparticles have an average diameter between 4 and 15 nm (pg. 4).
Regarding instant claim 4, Losada-Garcia et al. disclose that CuNPs@CALB-1 showed the smallest nanoparticles (around 4 nm) (pg. 4).
Regarding instant claim 12, Losada-Garcia et al. disclose a solution comprising Cu nanobiohybrid in the presence of hydrogen peroxide (pg. 3).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Losada-Garcia et al. (Nanomaterials, 2019) in view of Maduray et al. (Biological Trace Element Research, published online 7 October 2020) and Li et al. (RSC Advances, 2016).
The teachings of Losada-Garcia et al. are discussed above.
Regarding instant claim 5, Losada-Garcia et al. do not explicitly disclose inhibiting hepatitis C virus, SARS-CoV, MERS-CoV, or SARS-CoV-2 that causes Covid-19.
Maduray et al. teach that copper nanoparticles blocked hepatitis infection at the entry and attachment stages, and may have novel roles in treating chronic hepatitis patients (pg. 3168, col. 2).
Li et al. teach a self-assembly-disassembly approach to synthesize the enzyme–metal nanoparticle hybrid catalyst with highly retained enzymatic activity. Based on the self-assembled enzyme–copper phosphate nanocrystal 3D structure which has a high enzymatic activity, the reduction of copper phosphate to Cu nanoparticles produced the disassembled enzyme–Cu nanoparticle 0D nanostructure with both high enzymatic activity and high Cu-catalytic activity (pg. 20775).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to treat viruses, such as hepatitis C virus, with the Cu nanobiohybrid of Losada-Garcia et al. with the reasonable expectation that the Cu nanobiohybrid would retain its antiviral efficacy, as reasonably taught by Li et al.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Losada-Garcia et al. (Nanomaterials, 2019) in view of Rastogi et al. (Colloids and Surfaces B: Biointerfaces, 2013).
The teachings of Losada-Garcia et al. are discussed above.
Regarding instant claim 6, Losada-Garcia et al. do not explicitly disclose inhibiting or treating a bacterium selected from Escherichia coli and Bacillus subtilis.
Rastogi et al. teach a method for the synthesis of bovine serum albumin (BSA) and copper (Cu0) nanocomposites (Abstract; Scheme 1). Rastogi et al. teach that the synthesized composite has exhibited very good antibacterial activity thus promise potential applications in the field of antimicrobial agents, wound dressing etc. (pg. 141, Conclusions). Rastogi et al. teach that synthesized Cu NPs containing BSA composite material exhibited good antibacterial potential against both Gram positive and Gram negative bacterial strains. The minimum inhibitory concentration (MIC) of Cu NPs in the form Cu-BSA composite on Escherichia coli was calculated to be 50 g mL-1.
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to inhibit or control Escherichia coli with the Cu nanobiohybrid of Losada-Garcia et al. with the reasonable expectation that the Cu nanobiohybrid would exhibit very good antibacterial efficacy similar to the Cu-BSA composite of Rastogi et al.
Claims 7-11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Losada-Garcia et al. (Nanomaterials, 2019) in view of Maduray et al. (Biological Trace Element Research, published online 7 October 2020) and Li et al. (RSC Advances, 2016) as applied to claim 5 above, further in view of Cortes et al. (Diagnostic Microbiology and Infectious Disease, 2020).
Regarding instant claims 7-11 and 13-16, Losada-Garcia et al. do not explicitly disclose coating a surface with the Cu nanobiohybrid.
Cortes et al. teach that copper destroys the replication and propagation abilities of SARS-CoV, influenza, and other respiratory viruses, having high potential disinfection in hospitals, communities, and households. Copper can eliminate pathogenic organisms such as coronavirus bacterial strains, influenza virus, HIV, and fungi after a short period of exposure. Copper seems to be an effective and low-cost complementary strategy to help reduce the transmission of several infectious diseases by limiting nosocomial infectious transmission. Copper oxide or nanocompounds may be used as filters, face masks, clothing, and hospital common surfaces to reduce viruses and bacterial incubation (Abstract).
Cortes et al. teach that one of the causes of the high rate of transmission of respiratory viruses relates with it capability to survive on dry surfaces for more than 5 days on a variety of daily-use surfaces, such as ceramic tiles, glass, rubber, and stainless steel (pg. 4, col. 1).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to coat a surface, such as filters, face masks, clothing, hospital common surfaces, stainless steel, etc. with copper nanoparticles in order to help reduce the transmission of several infectious diseases. A person of ordinary skill in the art would have been motivated to coat the surfaces with the composition according to Losada-Garcia et al. in order to provide the copper nanoparticles for antiviral and antibacterial activity on the surface of the substrate.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Losada-Garcia et al. (Nanomaterials, 2019) in view of Maduray et al. (Biological Trace Element Research, published online 7 October 2020), Li et al. (RSC Advances, 2016), and Cortes et al. (Diagnostic Microbiology and Infectious Disease, 2020) as applied to claims 5, 7-11 and 13-16 above, further in view of Zinn (US 10,357,943).
Regarding instant claims 17-20, Losada-Garcia et al. do not explicitly disclose applying a coating dissolved in a hydroalcoholic solution on a surface of a product.
Zinn teaches that for application to the substructure of an article, the metal nanoparticles can be dispersed in an organic matrix containing one or more organic solvents (col. 14, ln. 3-5). The organic matrix contains one or more alcohols (col. 14, ln. 20-21).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to coat the surface of a product by dissolving the copper complexes according to Losada-Garcia et al. in an alcohol, such as ethanol, and applying the composition to the surface of the product, as reasonably suggested by Zinn. A person of ordinary skill in the art would have been able to determine through routine experimentation the necessary concentration ratio of alcohol to water to adequately dissolve the copper complex and effectively apply it to the surface of a product.
Claims 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Losada-Garcia et al. (Nanomaterials, 2019) in view of Lu et al. (Antiviral Therapy, 2008).
The teachings of Losada-Garcia et al. are discussed above.
Regarding instant claim 21, Losada-Garcia et al. teach lipase B from Candida antarctica (CAL-B), but does not explicitly disclose an enzyme or protein selected from Thermomyces lanuginosus lipase, Bacillus thermocatenulatus lipase, human albumin protein or catalase.
Lu et al. teach that human serum albumin stabilizes silver nanoparticles, and does not decrease the antimicrobial efficacy (pg. 256, col. 2 to pg. 257, col. 1; pg. 259, col. 1). Lu et al. teach that HSA might serves as a carrier for silver nanoparticles to the biological targets, that is, HBV-infected cells (pg. 259, col. 1).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to prepare a hybrid material comprising human serum albumin and Cu3(PO4)2 nanoparticles by substituting the human serum albumin as the protein in the method according to Losada-Garcia et al. A person of ordinary skill in the art would have a reasonable expectation of success because Lu et al. teach that human serum albumin is effective for stabilizing the formation of silver nanoparticles, and the resulting composite is effectively for controlling HBV. A person of ordinary skill in the art would reasonably expect HSA to be effective for stabilizing the synthesis of copper nanoparticles, and the resulting composites would have antimicrobial activity.
Regarding instant claim 22, Losada-Garcia et al. teach preparing a Candida antarctica lipase solution with sodium phosphate at pH 7 and stirring, addition of Cu2SO4·5H2O and incubation for 16 hours, and collecting and washing the product (pg. 2).
Regarding instant claim 23, Losada-Garcia et al. teach that the collected product was lyophilized (pg. 2).
Regarding instant claim 24, Losada-Garcia et al. teach that the copper salt is Cu2SO4·5H2O (pg. 2).
Regarding instant claim 25, Losada-Garcia et al. teach 10 mg/ml of copper salt added to the buffer solution (pg. 2).
Regarding instant claim 26, Losada-Garcia et al. teach a solution comprising Cu nanobiohybrid in the presence of hydrogen peroxide (pg. 3).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to follow the procedure according to Losada-Garcia-et al. for the formation of copper nanoparticles in an enzyme, except that the lipase B of Candida antarctica is replaced with human serum albumin, as suggested by Lu et al.
Conclusion
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/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616