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 .
Withdrawal of Final Rejection
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Claim Status
Claims 2 and 20 have been cancelled.
Claims 1, 3-19, and 21-38 are currently pending.
Claims 1, 3-19, and 21-38 are being examined in this application.
Priority
This application is a 371 of PCT/US2021/065009 (Filed on 12/22/2021), which claims priority to US Provisional application 63/129,435 (Filed on 12/22/2020).
Information Disclosure Statement
The IDS filed on 12/5/2023 have NOT been considered. See the attached. The list patent and applications are not in proper format for consideration by the Office. See MPEP 609.04(a) for content requirements for an IDS.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01.
Claim Objection(s) / Rejection(s) Withdrawn
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action that are not repeated and/or maintained in the instant Office action are withdrawn.
New / Maintained Claim Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description Rejection
Claims 1, 3-19, and 21-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims recite a fungicidal composition comprising a bacterially derived minicells and a bioactive agent that is an essential oil, and a method of using such a composition to “a locus” for antifungal application.
To satisfy the written description requirement, applicants may convey reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
Applicants may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. See, e.g., Vas-Cath, 935 F.2d at 1565, 19 USPQ2d at 1118.
The written description requirement of 35 U.SC. 112 exists independently of enablement requirement, and the requirement applies whether or not the case involves questions of priority. The requirement applies to all inventions and includes chemical inventions. The fact that the patent is directed to method entailing use of compounds, rather than to compounds per se, does not remove patentee’s obligation to provide a description of the compound sufficient to distinguish infringing methods from non-infringing methods. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ 2d 1886, 1890-93 (Fed. Cir. 2004).
With regard to the description requirement, applicants’ attention is invited to consider the decision of the Court of Appeals for the Federal Circuit, which holds that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it form other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)].
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species or by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d at 1568, 43 USPQ2d at 1406.
Claims 1 and 19 are drawn to a genus of compositions and method of using thereof comprising a genus of minicells. Claims 1 and 19 are also drawn to a genus of essential oil, which encompass any essential oil isolated from plants. Claims 1 and 19 are also drawn to a genus of “loci” or subjects, to which the composition (minicell and essential oil) can be applied for the purpose of achieving antifungal activity and encompasses any locus as the term is broadly used including plants, animals, human, as well as inanimate objects. Neither the instant specification nor the claims have demonstrated common structure and/or function for the claimed genus of minicells, the genus of essential oil, and the genus of “loci” (or subject). In addition, no representative numbers of species for each claimed genus are provided to show possession of the claimed genus minicells, the genus of essential oil (that would have antifungal activity) and genus of loci (or subjects).
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. (see MPEP 2163 II). In this case, the instant application did not provide core structure for the function of antifungal activity of essential oil for any loci/subject, nor representative number of species of composition (minicell and essential oil) that can be used in representative number of species of loci (or subjects).
The only examples provided in the instant specification are drawn to application of a three different essential oil to plant (crops) for antifungal treatment. Three examples of essential oil to one type of locus are not enough to show possession of the entire genus of any locus with any essential oil. The recited method of treating a locus with the claimed composition is essentially a trial and error process that would involve identifying essential oil with fungicidal activity that can applied to a particular subject or locus.
Therefore, applicants are not in possession of the claimed genus of methods and/or composition for treating fungi in any subject or locus. Applicant’s claimed scope represents only an invitation to experiment regarding possible composition that can be made and used as fungicide for any subject.
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.
Claim(s) 1, 3, 4, 6, 8-19, 21, 22, 24, and 26-38 is/are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS).
Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+). The instant specification broadly defines the term “bacterial minicell” as encompassing anucleate cells (Instant spec., p.15, para [0062]).
For Claim 1: Shakeel et al teach a composition comprising “anucleated cell” (or “bacterially derived minicell” (e.g. Abstract; pp.117+, claims 1, 12). The reference also teaches “agricultural compound” including a fungicide or other pesticides (e.g. e.g. Abstract; pp.117+, claims 1, 21) and the agricultural compound can be an essential oil such as “geraniol”, “peppermint oil” (e.g. p.53, ll.10+) which read on the essential oil of claim 1.
The recitation of “wherein the one or more fungi are controlled…” is a recitation of intended use of the claimed composition. The reference’s teaching read on the claimed composition, and thus would be capable of performing the intended use.
The recitation of “wherein the minicell enhances…” is a recitation of inherent property of the claimed composition. The reference teaches the same composition of a bacterial minicell and geraniol (an essential oil), and thus would have the same stabilizing property as evidenced by the instant specification.
For Claim 3: The reference teaches “encapsulation” of the agricultural compound (e.g. Claim 1; p.117; p.116, [00345]).
For Claims 4 and 6: The reference also teaches “agricultural compound” including a fungicide or other pesticides (e.g. e.g. Abstract; pp.117+, claims 1, 21) and the agricultural compound can be an essential oil such as “geraniol”, “peppermint oil” (e.g. p.53, ll.10+).
For Claims 8-9: The reference teaches various weight ratio between the minicell and the agricultural composition including 1:5, 5:1, or 1:1 (e.g. p.91, [00271]).
For Claim 10: The reference teaches the minicell can have various diameters such as 0.1-0.3um (e.g. p.30, [0103]).
For Claims 11-17: The recitations of claims 11-14 are recitations of intended use and/or inherent property of the claimed composition. The reference’s teaching read on the claimed composition, and thus would be capable of performing the intended use. The reference teaches the same composition of a bacterial minicell and geraniol (an essential oil), and thus would have the same stabilizing property as evidenced by the instant specification.
For Claims 18 and 36: The reference teaches the composition can include a surfactant (e.g. p.73, [00208]).
For Claims 19 and 29-31: The reference teaches the application of the agricultural composition with the minicell and the active compound to “a desired locus”/ “a plant”. (e.g. pp.122, claim 54+; pp.130+, claims 56+; pp.124+, claim 1+ ). The reference also teaches applying the “fungicide encapsulated in minicells... to an agricultural crop…” (e.g. p.116, [00345]), which reads on the application to control fungi of claim 19.
The recitation of “wherein the minicell enhances…” is a recitation of inherent property of the claimed composition. The reference teaches the same composition of a bacterial minicell and geraniol (an essential oil), and thus would have the same stabilizing property as evidenced by the instant specification.
For Claim 21, The reference teaches “encapsulation” of the agricultural compound (e.g. Claim 1; p.117; p.116, [00345]).
For Claims 22 and 24: The reference also teaches “agricultural compound” including a fungicide or other pesticides (e.g. e.g. Abstract; pp.117+, claims 1, 21) and the agricultural compound can be an essential oil such as “geraniol”, “peppermint oil” (e.g. p.53, ll.10+).
For Claims 26-27: The reference teaches various weight ratio between the minicell and the agricultural composition including 1:5, 5:1, or 1:1 (e.g. p.91, [00271]).
For Claim 28: The reference teaches the minicell can have various diameters such as 0.1-0.3um (e.g. p.30, [0103]).
For Claim 32-35: The recitations of claims 32-35 are recitations of inherent property of the claimed composition used in the claimed method. The reference’s teaches the same composition a bacterial minicell and geraniol (an essential oil), and the same method steps of applying said composition to plants, and thus would have the same stabilizing property under conditions such as at temperature of 37C or higher, same effects of controlling fungi, or same fungicidal activity, as evidenced by the instant specification.
For Claims 37 and 38: The reference teaches various formulations of the agricultural composition (minicell and active agent) including liquid, powder, granule, etc. (e.g. p. 129; claim 52; p.144, claim 53; pp.5-6, bridging para).
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.
Claim(s) 1, 3, 4, 5, 6, 7, 8-19, 21, 22, 23, 24, 25 and 26-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) in view of Balar et al (WO2011114347; 9/22/2011).
Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Shakeel et al do not explicitly teach the essential oil is eugenol or thymol as recited in claims 5, 7, 23 and 25.
However, Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract).
Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add/substitute other essential oils in the agriculture composition of Shakeel for the purpose of achieving desired antifungal activity in plants (crops), because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
‘743 Patent
Claims 1, 3-19, and 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11812743 (hereinafter referred to as ‘743 patents) in view of Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) and Balar et al (WO2011114347; 9/22/2011).
The ‘743 patent claims the following:
1. An agricultural formulation comprising:
an intact minicell comprising a biologically active compound within said minicell, wherein said biologically active compound comprises
a nucleic acid, wherein the nucleic acid targets a transcript encoding a polypeptide within a cell of a target,
wherein said target is a plant or a pest, and wherein the minicell is ribonuclease deficient.
2. The agricultural formulation of claim 1, further comprising at least one agricultural suitable additive or adjuvant.
10. The agricultural formulation of claim 1, wherein said minicell is treated with a solvent, an agent, a fixative, a preservative, or a cross-linking agent for better solubility, increased stability, or enhanced integrity.
12. A method of delivering a biologically active compound, comprising:
applying an agricultural formulation to a cell of a target, wherein said agricultural formulation comprises
an intact minicell comprising said biologically active compound within said minicell, wherein said biologically active compound comprises
a nucleic acid, wherein the nucleic acid targets a transcript encoding a polypeptide within said cell of said target,
wherein said target is a plant or a pest, and wherein the minicell is ribonuclease deficient.
The ‘743 Patent does not claim the composition with the minicell also contains an essential oil in specific weight ratio, as well as the surfactant.
However, Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract). Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add or incorporate essential oils in the agriculture composition of the ‘743 Patent for the purpose of achieving desired plant (crop) protection such as antifungal activity, because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
‘431 Patent
Claims 1, 3-19, and 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12324431 (hereinafter referred to as ‘431 patents) in view of Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) and Balar et al (WO2011114347; 9/22/2011).
The ‘431 patent claims the following:
1. An agricultural composition, comprising:
a) an insecticide and
b) a minicell encapsulating a nucleic acid that is capable of inducing RNA interference in an agricultural target pest.
8. The agricultural composition of claim 1, wherein the nucleic acid is capable of inducing RNA interference in at least one agricultural target pest selected from the group consisting of: fungus, insect, nematode, mite, and tick.
The ‘431 Patent does not claim the composition with the minicell also contains an essential oil in specific weight ratio, as well as the surfactant.
However, Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract). Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add or incorporate essential oils in the agriculture composition of the ‘743 Patent for the purpose of achieving desired plant (crop) protection such as antifungal activity, because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
‘439 Patent
Claims 1, 3-19, and 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12193439 (hereinafter referred to as ‘439 patents) in view of Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) and Balar et al (WO2011114347; 9/22/2011).
The ‘439 patent claims the following:
1. An agricultural composition, comprising:
a) a minicell encapsulating an insecticidal protein toxin that is capable of controlling or killing a plant pest or a plant pathogen.
2. The agricultural composition of claim 1, further comprising:
b) an agent for stabilizing said minicell encapsulating the insecticidal protein toxin.
3. The agricultural composition of claim 1, further comprising:
b) a solid, dry, or liquid carrier.
7. The agricultural composition of claim 1, wherein the insecticidal protein toxin is capable of controlling or killing said plant pathogen selected from the group consisting of: bacteria, fungi, molds, viruses, and combinations thereof.
16. The agricultural composition of claim 3, wherein the agricultural composition is sprayed unto a plant, a plant part, a plant growing medium, or soil.
24. An agricultural composition, comprising:
a) a minicell encapsulating an insecticidal protein toxin that is capable of controlling or killing a plant pest or a plant pathogen; and
b) a liquid carrier selected from the group consisting of a surfactant, an emulsifier, a crop oil concentrate, a penetrant, and combinations thereof,
wherein said liquid carrier is capable of increasing stability, wettability, or dispersability of said minicell encapsulating the insecticidal protein toxin, and wherein the agricultural composition is applied to a locus that is a plant, a plant part, a plant growing medium, or soil.
The ‘439 Patent does not claim the composition with the minicell also contains an essential oil in specific weight ratio, as well as the surfactant.
However, Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract). Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add or incorporate essential oils in the agriculture composition of the ‘743 Patent for the purpose of achieving desired plant (crop) protection such as antifungal activity, because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
‘265 Patent
Claims 1, 3-19, and 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-56 of U.S. Patent No. 11649265 (hereinafter referred to as ‘265 patents) in view of Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) and Balar et al (WO2011114347; 9/22/2011).
The ‘265 patent claims the following:
1. An anucleated cell composition comprising: (a) an intact anucleated cell having encapsulated within said cell at least one non-expressed agricultural compound, and wherein said at least one non-expressed agricultural compound is a pesticide.
2. The anucleated cell composition according to claim 1, further comprising: (b) at least one agriculturally acceptable carrier.
29. The anucleated cell composition according to claim 1, wherein the at least one non-expressed agricultural compound is a fungicide.
33. The anucleated cell composition according to claim 1, formulated as a liquid, dry composition, powder, granule, seed coating, drench, in-furrow composition, or foliar spray.
The ‘265 Patent does not claim the composition with the minicell also contains an essential oil as the fungicide in specific weight ratio, as well as the surfactant.
However, Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract). Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add or incorporate essential oils in the agriculture composition of the ‘743 Patent for the purpose of achieving desired plant (crop) protection such as antifungal activity, because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
‘518 Patent
Claims 1, 3-19, and 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11970518 (hereinafter referred to as ‘518 patents) in view of Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) and Balar et al (WO2011114347; 9/22/2011).
The ‘518 patent claims the following:
1. A minicell composition, comprising:
a) a minicell having encapsulated within said minicell an agrochemical.
2. The minicell composition according to claim 1, further comprising:
b) at least one agriculturally acceptable carrier.
20. A method of delivering an agrochemical to a locus, comprising: applying the minicell composition according to claim 1 to a locus.
21. A method of delivering an agrochemical to a plant, comprising: applying the minicell composition according to claim 1 to a plant.
The ‘518 Patent does not claim the composition with the minicell also contains an essential oil as the fungicide in specific weight ratio, as well as the surfactant.
However, Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract). Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add or incorporate essential oils in the agriculture composition of the ‘743 Patent for the purpose of achieving desired plant (crop) protection such as antifungal activity, because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
‘559 Application
Claims 1, 3-19, and 21-38 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/332559 (hereinafter referred to as ‘559 Application) in view of Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) and Balar et al (WO2011114347; 9/22/2011).
The ‘559 Application claims the following:
1. (Currently Amended) A bioprocessing system for minicell production, comprising: (a) at least one bioreactor that continually produces a population of minicells; (b) a minimal medium for minicell production; and (c) at least one parental bacterial cell strain capable of producing said population of minicells; wherein the at least one bioreactor has an oxygen uptake rate between about 100 mmol/L/Hr and about 200300 mmol/L/Hr; and wherein the minicell production yield is at least 60% of total cells in said bioreactor.
15. (Original) The bioprocessing system of claim 1, wherein said minicell is capable of encapsulating an agricultural agent.
16. (Original) The bioprocessing system of claim 15, wherein said agricultural agent is an agrochemical compound or a biologically active compound.
18. (Original) The bioprocessing system of claim 16, wherein said biologically active compound is selected from a nucleic acid, a peptide, a protein, an essential oil, and combinations thereof.
20. (Previously Presented) The bioprocessing system of claim 18, wherein the essential oil comprises geraniol, eugenol, genistein, carvacrol, thymol, pyrethrum, or carvacrol.
The ‘559 Application does not claim the composition with the minicell also contains an essential oil as the fungicide in specific weight ratios, as well as the surfactant.
However, Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract). Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add or incorporate essential oils in the agriculture composition of the ‘743 Patent for the purpose of achieving desired plant (crop) protection such as antifungal activity, because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
This is a provisional nonstatutory double patenting rejection.
‘957 Application
Claims 1, 3-19, and 21-38 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-29 of copending Application No. 18/594957 (hereinafter referred to as ‘957 Application) in view of Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) and Balar et al (WO2011114347; 9/22/2011).
The ‘957 Application claims the following:
2. (New) A minicell composition, comprising: a minicell having encapsulated within said minicell a fertilizer.
3. (New) The minicell composition according to claim 2, further comprising: an agriculturally acceptable carrier.
27. (New) A method of delivering a fertilizer to a locus, comprising: applying the minicell composition according to claim 2 to a locus.
28. (New) A method of delivering a fertilizer to a plant, comprising: applying the minicell composition according to claim 2 to a plant.
29. (New) A method of delivering a fertilizer to a crop, comprising: applying the minicell composition according to claim 2 to a crop.
The ‘957 Application does not claim the composition with the minicell also contains an essential oil as the fungicide in specific weight ratios, as well as the surfactant.
However, Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract). Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add or incorporate essential oils in the agriculture composition of the ‘743 Patent for the purpose of achieving desired plant (crop) protection such as antifungal activity, because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
This is a provisional nonstatutory double patenting rejection.
‘505 Application
Claims 1, 3-19, and 21-38 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-59 of copending Application No. 19/200505 (hereinafter referred to as ‘505 Application) in view of Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) and Balar et al (WO2011114347; 9/22/2011).
The ‘505 Application claims the following:
33. (New) An agricultural composition, comprising: a minicell encapsulating i) a nucleic acid that is capable of inducing RNA interference; and ii) a biologically active compound.
48. (New) A method of applying an agricultural composition to a target, the method comprising:(a) applying to a target an agricultural composition, comprising: a minicell encapsulating i) a nucleic acid that is capable of inducing RNA interference or ii) a biologically active compound.
The ‘505 Application does not claim the composition with the minicell also contains an essential oil as the fungicide in specific weight ratios, as well as the surfactant.
However, Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract). Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add or incorporate essential oils in the agriculture composition of the ‘743 Patent for the purpose of achieving desired plant (crop) protection such as antifungal activity, because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
This is a provisional nonstatutory double patenting rejection.
‘262 Application
Claims 1, 3-19, and 21-38 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 18/037262 (hereinafter referred to as ‘262 Application) in view of Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) and Balar et al (WO2011114347; 9/22/2011).
The ‘262 Application claims the following:
1. (Currently Amended) An agricultural composition for controlling growth of one or more plant species comprising:(i) a minicell and (ii) a bioactive agent having herbicidal activity, wherein the bioactive agent is selected from the group consisting of: a botanical blend, a metabolite, at least one microbial species, and combinations thereof; and wherein the growth of the plant species is controlled with application of said composition to the plant species;, and wherein the minicell enhances the herbicidal activity of the bioactive agent; wherein a mixture ratio of the bioactive agent and the minicell is from 1:4 to 4:1 in volume to volume; and wherein the bioactive agent in the presence of the minicell has at least 5% higher herbicidal activity than the bioactive agent alone over a week after treatment.
3. (Previously Presented) The agricultural composition of claim 1, wherein the minicell is capable of encapsulating the bioactive agent and wherein the bioactive agent is present within the minicell.
4. (Previously Presented) The agricultural composition of claim 1, wherein said botanical blend is a plant extract or oil having a herbicidal activity.
14. (Withdrawn - Currently Amended) A method of controlling growth of one or more plant species, the method comprising: applying an agricultural composition for controlling growth of one or more plant species comprising:(i) a minicell and (ii) a bioactive agent having herbicidal activity, wherein the bioactive agent is selected from the group consisting of: a botanical blend, a metabolite, at least one microbial species, and combinations thereof; and wherein the growth of the plant species is controlled with said application of the composition and wherein the minicell enhances the herbicidal activity of the bioactive agent; wherein the minicell enhances the herbicidal activity of the bioactive agent; wherein a mixture ratio of the bioactive agent and the minicell is from 1:4 to 4:1 in volume to volume; and wherein the bioactive agent in the presence of the minicell has at least 5% higher herbicidal activity than the bioactive agent alone over a week after treatment.
19. (Withdrawn) The method of claim 14, wherein said botanical blend is a plant extract or oil having a herbicidal activity.
The ‘262 Application does not claim the composition with the minicell also contains an essential oil as the fungicide in specific weight ratios, as well as the surfactant.
However, Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract). Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add or incorporate essential oils in the agriculture composition of the ‘743 Patent for the purpose of achieving desired plant (crop) protection such as antifungal activity, because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
This is a provisional nonstatutory double patenting rejection.
‘577 Application
Claims 1, 3-19, and 21-38 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-13, and 15-34 of copending Application No. 17/788577 (hereinafter referred to as ‘577 Application) in view of Shakeel et al (WO2018201161; 11/1/2018; filed on 4/30/2018 or earlier; cited in IDS) and Balar et al (WO2011114347; 9/22/2011).
The ‘577 Application claims the following:
1. (Currently Amended) A composition, comprising: a minicell encapsulating an essential oil, wherein the minicell and the essential oil are present in a weight-to-weight ratio of about 5:1 to about 1:5 in the composition, and wherein the minicell has at least 80% encapsulation efficiency to retain the essential oil within the minicell.
2. (Previously Presented) The composition of claim 1, wherein the minicell and the essential oil are present in a weight-to-weight ratio of about 1:1.
3. (Original) The composition of claim 1, wherein the minicell is derived from a bacterial cell.
4. (Original) The composition of claim 1, wherein the minicell is less than or equal tol pm in diameter.
8. (Previously Presented) The composition of claim 1, wherein the essential oil comprises geraniol, eugenol, genistein, thymol, pyrethrum or carvacrol.
9. (Previously Presented) The composition of claim 1, wherein the essential oil comprises geraniol.
10. (Previously Presented) The composition of claim 1, wherein the essential oil comprises eugenol.
11. (Previously Presented) The composition of claim 1, wherein the essential oil comprises genistein.
12. (Previously Presented) The composition of claim 1, wherein the essential oil comprises thymol.
The ‘577 Application does not claim a method of using a composition with the minicell also contains an essential oil as the fungicide in specific weight ratios, as well as the surfactant.
However, Shakeel et al, throughout the reference, teach anucleate cell (i.e. bacterially derived minicell) and various application thereof including fungicides. (e.g. Abstract; p. 117, claim 1; p.54+, [00193]+), as discussed supra.
Balar et al, throughout the reference, teaches various fungicides used in agricultural application especially with agriculture crops (e.g. Abstract). Balar et al teach various essential oils including geraniol, thymol, and eugenol as well as the advantage of including these essential oils for synergistic effect of protecting plants from bacteria and fungus (e.g. Abstract; p.1, para 3; claims 2, 5, 11; pp.1-2 bridging para).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add or incorporate essential oils in the agriculture composition of the ‘743 Patent for the purpose of achieving desired plant (crop) protection such as antifungal activity, because essential oils such as geraniol, thymol, and eugenol are known to have antifungal activities and are routinely used as fungicides in various applications including agricultural usage as taught by Shakeel and Balar. In addition, because both the Shakeel and Balar references teach methods of using various essential oils for antifungal (or plant protection) purpose with equal or better (synergistic effects) results, it would have been obvious to one skilled in the art to substitute one essential oil for another to achieve the predictable result of antifungal activity.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Shakeel et al have demonstrated incorporating different essential oils with bacterial minicells, and the application thereof.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicants’ arguments against the previous rejections are moot in light of the new claim rejections set forth above.
Conclusion and Correspondence
No claims are allowed.
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/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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