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Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-4 are pending in the application and are being examined on the merits.
Priority
This application is filed under 35 U.S.C. 371 as a national stage of international application PCT/IB2021/061353, filed December 6, 2021, which claims foreign priority under 35 U.S.C. 119(a)-(d) to Italian application no. 102020000030200, filed December 9, 2020. A certified copy of the foreign priority document has been filed in this application on June 9, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 12, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Claim Objections
Claims 1, 3, and 4 are objected to for reciting names of bacteria and fungi that are not italicized. In the interest of improving claim form, it is suggested that the names of bacteria and fungi recited in claims 1, 3, and 4 be italicized, e.g., Flavobacterium.
Claim 1 is also objected to in the recitation of “Trichoderma arzianum,” which is a misspelling of “Trichoderma harzianum.”
Claim 4 is also objected to in the recitation of “Saccharomyces cerevisae,” which is a misspelling of “Saccharomyces cerevisiae.”
Claim Rejections - 35 USC § 112(b)
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.
Claim 3 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 is indefinite in the recitation of “Pseudomonas aeruginosa secondary” and “Bacillus sp. Secondary YP1” because it is unclear as to the intended meaning of “secondary” and “Secondary,” respectively, in the noted phrases. It is suggested that applicant clarify the meaning of the term “secondary” and “Secondary” in claim 3.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Applicant’s attention is directed to the "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products”, released on December 16, 2014.
Claim Interpretation: Claim 1 is drawn to a plastic-degrading solution comprising Flavobacterium, Enterobacter asburiae, Ideonella sakaiensis, Sphingomonas, Bacillus subtilis and extracts of Fusarium oxysporum, Purpureocillium lilacinum, Pestalotiopsis microspora, Trichoderma arzianum and Alcaligenes eutrophus.
The recited “Flavobacterium, Enterobacter asburiae, Ideonella sakaiensis, Sphingomonas, Bacillus subtilis” in claim 1 encompass naturally-occurring Flavobacterium, Enterobacter asburiae, Ideonella sakaiensis, Sphingomonas, and Bacillus subtilis.
In view of the disclosure of the specification (e.g., specification at p. 4, lines 4, 10, 14, and 19), the term “extracts” in claim 1 is interpreted as encompassing, e.g., naturally-occurring polypeptides derived from the recited Fusarium oxysporum, Purpureocillium lilacinum, Pestalotiopsis microspora, Trichoderma arzianum and Alcaligenes eutrophus.
Given a broadest reasonable interpretation, only a single one of the Flavobacterium, Enterobacter asburiae, Ideonella sakaiensis, Sphingomonas, Bacillus subtilis and extracts of Fusarium oxysporum, Purpureocillium lilacinum, Pestalotiopsis microspora, Trichoderma arzianum and Alcaligenes eutrophus of claim 1 has plastic-degrading activity. For example, claim 1 encompasses a solution comprising a plastic-degrading Flavobacterium, while the remaining Enterobacter asburiae, Ideonella sakaiensis, Sphingomonas, Bacillus subtilis and extracts of Fusarium oxysporum, Purpureocillium lilacinum, Pestalotiopsis microspora, Trichoderma arzianum and Alcaligenes eutrophus are not required to have plastic-degrading activity.
Claim 2 is drawn to the solution according to claim 1, further comprising titanium dioxide.
The recited “titanium dioxide” encompasses naturally-occurring titanium dioxide.
Claim 3 is drawn to the solution according to claim 1, further comprising at least one of selected from the group consisting of Thermobifida fusca, Bacillus megaterium, Pseudomonas aeruginosa secondary and Bacillus sp. Secondary YP1.
The recited “Thermobifida fusca, Bacillus megaterium, Pseudomonas aeruginosa secondary and Bacillus sp. Secondary YP1” encompass naturally-occurring Thermobifida fusca, Bacillus megaterium, Pseudomonas aeruginosa, and Bacillus sp. YP1.
Claim 4 is drawn to the solution according to claim 1, further comprising at least one extract selected from the group consisting of Aspergillus tubingensis and Saccharomyces cerevisae.
In view of the disclosure of the specification (e.g., specification at paragraph bridging pp. 4-5 and p. 5, line 6), the term “extract” in claim 4 is interpreted as encompassing, e.g., naturally-occurring polypeptides derived from the recited Aspergillus tubingensis and Saccharomyces cerevisiae.
Given a broadest reasonable interpretation, the plastic-degrading solution of claims 1-4 encompass a combination of naturally-occurring components.
Patent Eligibility Analysis Step 1: The claims are drawn to a composition of matter, which is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claims recite a composition comprising a combination of naturally occurring components, which is considered to be a law of nature or a natural phenomenon (a natural product). There is no evidence of record of a naturally occurring counterpart to the claimed composition, so the composition is compared to the individual components as they occur in nature (see MPEP 2106.04(c).II.A). There is no indication in the specification or evidence of record that the combination of components has any characteristics (structural, functional, or otherwise) that are different from the corresponding individual components as each occurs in nature. Furthermore, there is no indication in the specification or evidence of record that combining these components changes the structure, function, or other properties of the naturally occurring components. In other words, the overall combination of components does not render the resulting composition different from each of the individual components. Thus, the plastic-degrading solution of claims 1-4 is not considered to have markedly different characteristics from what occurs in nature, and is considered to be a “product of nature” exception. Accordingly, the solution of claims 1-4 is directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claims beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claims only recite the products of nature, without more and do not include any additional elements that could add significantly more to the judicial exception.
As such, the claims do not qualify as eligible subject matter. For these reasons the claim is rejected under section 101 as being directed to non-statutory subject matter.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Purohit et al. (Current Genomics 21:253-270, May 2020; cited on the attached Form PTO-892; hereafter “Purohit”) in view of
Yang et al. (Environ. Sci. Technol. 48:13776-13784, 2014; cited on the attached Form PTO-892; hereafter “Yang”),
Venisha et al. (IRJET 7:4737-4739, August 2020; cited on the attached Form PTO-892; hereafter “Venisha”),
Nimchua et al. (Biotechnol. J. 2:361-364, 2007; cited on the attached Form PTO-892; hereafter “Nimchua”),
Oda et al. (J. Ferment. Bioeng. 80:265-269, 1995; cited on the attached Form PTO-892; hereafter “Oda”),
Russell et al. (Appl. Environ. Microbiol. 77:6076-6084, 2011; cited on the attached Form PTO-892; hereafter “Russell”),
Sowmya et al. (Environ. Monit. Assess 186:6577-6586, 2014; cited on the attached Form PTO-892; hereafter “Sowmya”), and
Doi et al. (FEMS Microbiol. Rev. 103:103-108, 1992; cited on the attached Form PTO-892; hereafter “Doi”), and
as evidenced by Luangsa-ard et al. (FEMS Microbiol. Lett. 321:141-149, 2011; cited on the attached Form PTO-892; hereafter “Luangsa-ard”).
Claim 1 is drawn to a plastic-degrading solution comprising Flavobacterium, Enterobacter asburiae, Ideonella sakaiensis, Sphingomonas, Bacillus subtilis and extracts of Fusarium oxysporum, Purpureocillium lilacinum, Pestalotiopsis microspora, Trichoderma arzianum and Alcaligenes eutrophus; and
claim 3 is drawn to the solution according to claim 1, further comprising at least one of selected from the group consisting of Thermobifida fusca, Bacillus megaterium, Pseudomonas aeruginosa secondary and Bacillus sp. Secondary YP1.
Purohit teaches more than 80% of the annual plastic generation is shared by high molecular weight polymers such as polyamine (PA), polyethylene (PE), polyethylene terephthalate (PET), polypropylene (PP), polystyrene (PS), polyurethane (PU) and polyvinylchloride (PVC) (p. 253, column 2, top) and teaches degradation of non-degradable synthetic polymers using diverse microbial agents such as bacteria and fungi as an option for managing plastic waste (p. 253, Abstract; p. 254, column 1, middle). Purohit teaches the oligomers and monomers of plastic are assimilated by various microbes inside their cell and catabolized to produce the energy, the assimilation helps in the conversion of monomeric plastic into various secondary metabolites, which later on excreted into the environment (p. 254, column 2, bottom). Purohit teaches it is well established that microbes always function in consortia, especially in different phases of biofilm formation on the polymer surface (p. 255, column 1, bottom) and suggests engineering the microbial community and their metabolic activity in the plastisphere to speed up the plastic degradation process (p. 256, column 1, bottom). Purohit teaches various microbes that are associated with plastic degradation including Flavobacterium (p. 256, column 2, top; Table 1, pp. 257-258; paragraph bridging pp. 258-259), Ideonella sakaiensis (p. 260, Table 2), Bacillus subtilis (p. 260, Table 2; p. 264, column 1, top), and Thermobifida fusca (p. 260, Table 2). Purohit teaches direct enzyme delivery for plastics degradation (p. 264, column 2, top) and teaches serine hydrolase from Pestalotiopsis microspora for degradation of polyethylene/polyester (p. 260, Table 2).
The difference between Purohit and claims 1 and 3 is that Purohit does not teach all microbes and extracts recited in claims 1 and 3, particularly Enterobacter asburiae, Sphingomonas, and extracts of Fusarium oxysporum, Purpureocillium lilacinum, Pestalotiopsis microspore, Trichoderma arzianum, and Alcaligenes eutrophus, and combining the microbes and extracts recited in claims 1 and 3 into a plastic-degrading solution.
Regarding Enterobacter asburiae for plastic degradation, Yang teaches polyethylene is the most common petroleum-based plastic (p. 13776, column 1) and teaches Enterobacter asburiae strain YT1, which is capable of degrading polyester (p. 13776, Abstract), as a promising plastic-degrading microorganism (p. 13777, column 1, bottom).
Regarding Sphingomonas for plastic degradation, Venisha teaches that microorganisms play a vital role in the degradation of plastics (p. 4737, column 1, bottom) and teaches isolation of Sphingomonas sp. VC1 with the ability to degrade biodegradable plastics (p. 4737, Abstract).
Regarding an extract of Fusarium oxysporum for plastic degradation, Nimchua teaches an enzyme preparation from Fusarium oxysporum strain LCH 1, which exhibited a high esterase activity and hydrolyzed polyethylene terephthalate fibers (p. 361, Abstract; p. 362, column 1; p. 363, column 1).
Regarding an extract of Purpureocillium lilacinum for plastic degradation, Oda teaches PHB is receiving much attention as a material for biodegradable plastics and PCL is also a biodegradable plastic (p. 265, column 1) and teaches an investigation of enzymes depolymerizing these plastics by Paecilomyces lilacinus strain D218 (p. 265, paragraph bridging columns 1-2). Oda teaches a crude enzyme preparation of Paecilomyces lilacinus strain D218 comprising a PHB and PCL depolymerase activity (p. 267, columns 1-2). Evidentiary reference Luangsa-ard is cited to show that Paecilomyces lilacinus has been renamed Purpureocillium lilacinus (p. 141, Abstract).
Regarding an extract of Pestalotiopsis microspora for plastic degradation, Russell teaches bioremediation is an important approach to waste reduction that relies on biological processes to break down a variety of pollutants and to explore teaches screening of endophytic fungi for their ability to degrade the synthetic polymer polyester polyurethane (p. 6076, abstract). Russell teaches two isolates of Pestalotiopsis microspora with the ability to degrade polyester polyurethane (p. 6077, column 1, middle) and teaches a crude extracellular enzyme fraction comprising a serine hydrolase that is responsible for the polyester polyurethane degrading activity (p. 6078, column 1; p. 6081, columns 1-2).
Regarding an extract of Trichoderma arzianum for plastic degradation, Sowmya teaches that with the excessive use of plastics and increasing pressure being placed on capacities available for plastic waste disposal, the need for biodegradable plastics and biodegradation of plastic has assumed increasing importance in the last few years, noting that polyethylene is the most commonly found solid waste (paragraph bridging pp. 6577-6578). Sowmya teaches isolation of Trichoderma harzianum, which degrades polyethylene, and crude extraction of the responsible enzymes (p. 6577, Abstract).
Regarding an extract of Alcaligenes eutrophus for plastic degradation, Purohit teaches PHB polymerase for degradation of PHB plastic (p. 255, column 1) and Doi teaches the degradation of PHB by Alcaligenes eutrophus is initiated by a PHA depolymerase (p. 103, column 2; p. 104, Figure 1; 106, columns 1-2).
According to MPEP 2144.06.I, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” Also, according to MPEP 2141.I, “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Purohit taught using diverse microbial agents such as bacteria and fungi and direct enzyme delivery for plastics degradation and managing plastic waste and Purohit, Yang, Venisha, Nimchua, Oda, Russell, Sowmya, and Doi each taught a plastic-degrading bacterium, fungus, or plastic-degrading enzyme that is useful for degrading plastics. In accordance with MPEP 2144.06.I and MPEP 2141.I, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the Flavobacterium, Enterobacter asburiae, Ideonella sakaiensis, Sphingomonas, and Bacillus subtilis plastic-degrading microbes and plastic-degrading enzymes extracted from Fusarium oxysporum, Purpureocillium lilacinum, Pestalotiopsis microspora, Trichoderma arzianum and Alcaligenes eutrophus taught by the cited prior art into a solution intended for plastic degradation. One would have had a reasonable expectation of success because Purohit taught using diverse microbial agents such as bacteria and fungi and direct enzyme delivery for plastics degradation and managing plastic waste. Therefore, the plastic-degrading solution of claims 1 and 3 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Purohit in view of Yang, Venisha, Nimchua, Oda, Russell, Sowmya, and Doi and as evidenced by Luangsa-ard as applied to claims 1 and 3 above, and further in view of Xu et al. (Polym. Int. 68:1332-1340, 2019; cited on the attached Form PTO-892; hereafter “Xu”).
Claim 2 is drawn to the solution according to claim 1, further comprising titanium dioxide.
The relevant teachings of Purohit, Yang, Venisha, Nimchua, Oda, Russell, Sowmya, and Doi and evidentiary reference Luangsa-ard as applied to claims 1 and 3 are set forth above.
Regarding claim 2, Purohit further teaches a pro-oxidant component including a salt of titanium to accelerate oxidation of the plastic polymer as a strategy commonly used for microbial degradation of plastic (p. 262, Table 3).
The combination of Purohit, Yang, Venisha, Nimchua, Oda, Russell, Sowmya, and Doi does not teach titanium dioxide as a prooxidant for degradation of plastic.
Xu teaches accelerating degradation of polyethylene films in agricultural plastic mulch with pro-oxidants such as titanium dioxide, noting that titanium dioxide has attracted much interest because of its versatility, economy, stability, abundance and non-toxicity (p. 1332, column 1).
In view of Xu, it would have been obvious to one of ordinary skill in the art before the effective filing date to include titanium dioxide as a pro-oxidant in the plastic-degrading solution of the combination of Purohit, Yang, Venisha, Nimchua, Oda, Russell, Sowmya, and Doi. One would have been motivated and would have expected success because Purohit taught a pro-oxidant component including a titanium salt to accelerate oxidation of plastic polymer and Xu taught accelerating degradation of polyethylene films in agricultural plastic mulch with pro-oxidant titanium dioxide. Therefore, the plastic-degrading solution of claim 2 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Purohit in view of Yang, Venisha, Nimchua, Oda, Russell, Sowmya, and Doi and as evidenced by Luangsa-ard as applied to claims 1 and 3 above, and further in view of Khan et al. (Environmental Pollution 225:469-480, 2017; cited on the attached Form PTO-892; hereafter “Khan”).
Claim 4 is drawn to the solution according to claim 1, further comprising at least one extract selected from the group consisting of Aspergillus tubingensis and Saccharomyces cerevisae.
The relevant teachings of Purohit, Yang, Venisha, Nimchua, Oda, Russell, Sowmya, and Doi and evidentiary reference Luangsa-ard as applied to claims 1 and 3 are set forth above.
The combination of Purohit, Yang, Venisha, Nimchua, Oda, Russell, Sowmya, and Doi does not teach an extract of Aspergillus tubingensis or Saccharomyces cerevisiae for degradation of plastic.
Khan teaches various commonly used synthetic plastics include polyester polyurethane (p. 469, column 2) noting a need to search new alternative means to solve the problems posed by PU waste accumulation and suggesting biodegradation for polyester polyurethane waste management (p. 470, column 1, middle to bottom). Khan teaches isolation of a strain of Aspergillus tubingensis with the ability to degrade polyester polyurethane (p. 469, Abstract). Khan teaches a crude enzyme comprising the polyester polyurethane degrading activities (p. 471, columns 1-2; p. 474, columns 1-2).
In view of Khan, it would have been obvious to one of ordinary skill in the art before the effective filing date to include Khan’s polyester polyurethane-degrading enzymes extracted from Aspergillus tubingensis in the plastic-degrading solution of the combination of Purohit, Yang, Venisha, Nimchua, Oda, Russell, Sowmya, and Doi. One would have been motivated and would have expected success because Purohit taught using diverse microbial agents such as bacteria and fungi and direct enzyme delivery for plastics degradation and managing plastic waste, and Khan taught a crude enzyme derived from Aspergillus tubingensis with the ability to degrade polyester polyurethane. Therefore, the plastic-degrading solution of claim 4 would have been obvious to one of ordinary skill in the art before the effective filing date.
Conclusion
Status of the claims:
Claims 1-4 are pending.
Claims 1-4 are rejected.
No claim is in condition for allowance.
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/David Steadman/Primary Examiner, Art Unit 1656