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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
Claims 33-62 are pending. Claims 1-32 are cancelled. Claims 47-62 are withdrawn. Claims 33-46 are under consideration in this action.
Change in Examiner
The examiner for your application in the USPTO has changed. Examiner Monica Shin can be reached at 571-272-7138.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 33-47) and the following species (reading on claims 33-46) in the reply filed on September 23, 2025 is acknowledged:
Single nucleic acid: RNA
Biologically active compound: protein.
Claims 47-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 23, 2025.
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.
Claims 33-37, 40, 41, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Beghyn et al. (Beghyn) (US 2012/0297501 A1; published Nov. 22, 2012), Giacalone et al. (Giacalone) (US 2010/0112670 A1; published May 6, 2010), and Sabbadini et al. (Sabbadini) (US 2013/0337545 A1; published Dec. 19, 2013).
With regards to Claims 33-35, Beghyn discloses genetic control of infestation by insect pest species, particularly prevention and/or control of pest infestation of plants, using interfering RNA molecules (abstract). Beghyn investigated the use of RNAi to down-regulate genes in such a way as to impair the ability of the insect pest to survive, grow, progress through different stages of the insect’s life cycle, colonize specific environments and/or infest host organisms and thus limit the damage caused by the pest (para.0009).
The method for generating any of the interfering RNAs of the invention comprises the steps of (i) contacting a polynucleotide encoding said interfering RNA or a DNA construct comprising the same with cell-free components; or (ii) introduction (e.g., by transformation, transfection, or injection) a polynucleotide encoding said interfering RNA or a DNA construct comprising the same into a cell (para.0231). Accordingly, Beghyn discloses a host cell transformed with any of the polynucleotides described herein. Further encompassed by the present host cells comprising any of the interfering RNAs of the current invention, any of the polynucleotides of the current invention or a DNA construct comprising the same. The host cell may be a prokaryotic cell or a eukaryotic cell (par.0215).
Beghyn discloses that in situations wherein interfering RNA is expressed within a host cell and/or is used to prevent and/or control pest infestation of a host organism, it is preferred that the interfering RNA does not exhibit significant “off-target” effects, i.e., the interfering RNA does not affect expression of genes within the host (para.0218).
Beghyn discloses a method for preventing and/or controlling pest infestation, comprising contacting an insect pest species with an effective amount of at least one interfering RNA wherein the RNA functions upon uptake by said pest to down-regulate expression of an essential pest target gene (para.0220).
The “interfering RNA” encompasses any type of RNA molecule capable of down-regulating or “silencing” expression of a target gene, including but not limited to sense RNA, antisense RNA, short interfering RNA (sRNA), microRNA (miRNA), double-stranded RNA (dsRNA), hairpin RNA, and the like (para.0176).
With regards to Claims 36 and 37, the interfering RNAs may be used for the prevention and/or control of any insect pest belonging to the Orders of Coleoptera, Lepidoptera, Diptera, Dichyopetera, Orthoptera, Hemiptera, and Siphonaptera (para.0219).
Beghyn also discloses a method for preventing and/or controlling insect pest infestation in a field of crop plants, said method comprising expressing in said plants an effective amount of an interfering RNA as described herein (par.0221).
Beghyn does not appear to explicitly disclose a minicell encapsulating a i) a nucleic acid that is capable of inducing RNA interference; and ii) a biologically active compound (Claim 33), or wherein the biologically active compound is a protein (Claims 40, 41, and 44; elected species). Giacalone and Sabbadini are relied upon for these disclosures. Their teachings are set forth herein below.
Giacalone discloses that eubacterial minicells are capable of encapsulating and delivering several classes of biologically active compounds that have therapeutic, prophylactic, or diagnostic benefit to an animal. Types of the biologically active compounds (payloads) that can be delivered by minicells include, but are not limited to, small molecules, nucleic acids, polypeptides, radioisotope, lipids, lipopolysaccharides, and any combination thereof (para.0096, 0102).
Minicells displaying antibodies, antibody derivatives, and other targeting moieties on their surfaces are used to target specific cell types in vivo to preferentially deliver their bioactive payloads to the targeted tissue, organ, and cell type (para.0085).
Giacalone discloses a eubacterial minicell comprising one or more biologically active compounds, wherein at least one of the biologically active compounds is selected from the group consisting of a radioisotope, a polypeptide, a nucleic acid, and a small molecule (Giacalone claims 41, 43, and 44).
Among the suitable nucleic acids include RNA. RNAs include, but are not limited to messenger RNA (mRNA), transfer RNA (tRNA), and small nuclear RNAs. Many RNAs, classified as antisense RNAs, including but are not limited to small-interfering RNAs (siRNA), short hairpin RNAs (shRNAs), and full length antisense RNAs. Micro RNAs are also included (para.0100).
Proteins are also among the suitable payload types. Proteins are comprised of polypeptides and are encoded for by DNA. Proteins can be biologically functional, structural, and can serve as immunogens or serve other therapeutic purposes (para.0101-0102).
Giacalone also discloses compositions, which refer to a mixture comprising at least one carrier and one or more minicell compositions (para.0107, 0111). The compositions may be administered to any organism (para.0113).
Sabbadini discloses minicells used to deliver biologically active compounds, including polypeptides and nucleic acids. In some embodiment, the minicells display ligands or binding moieties that target the minicell to a desired host cell (abstract; para.0180).
Sabbadini discloses that Bacillus thurigenesis produces a toxin, CrylAc (reading on an insecticidal protein toxin), that kills plant chewing insect larvae as well as mosquito larvae. Minicell technology allows for delivery of the toxin. The minicells are distributed (e.g., crop dusting) to the area of infestation. The toxin/minicells are ingested by the larvae and kill the larvae as the minicells passes through the guy (para.0873-0874).
With regards to Claims 33, 40, 41, and 44, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date to the combine the teachings of Beghyn and Giacalone and load Beghyn’s interfering RNA molecules (e.g., RNA molecules disclosed by Beghyn) into Giacalone’s minicell for delivery of the interfering RNA molecules to plants to prevent and/or control pest infestation. One of ordinary skill in the art would have been motivated to do so as minicells allow for targeting of the delivery so that the payload is preferentially delivered to the target (e.g., insect pests). One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Beghyn is directed to the delivery of interfering RNA molecules (payload; active component) to plants, and Giacalone discloses that minicells are known to encapsulate and deliver RNA to any organism.
Further, one of ordinary skill in the art would have found it prima facie obvious to further combine the teachings of Beghyn and Giacalone with the teachings of Sabbadini and further encapsulate insecticidal protein toxin (e.g., Sabbadini’s CrylAc) into the minicell of the combined teachings of Beghyn and Giacalone discussed above. One of ordinary skill in the art would have been motivated to do so in order to not only have targeted delivery of the payload, but also to widen the scope of pests controlled and have different mechanisms of action at play to control pest infestation on plants. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Giacalone discloses that minicells can encapsulate at least one biologically active compounds (e.g., proteins and nucleic acids), and both Beghyn’s interfering RNA molecule and Sabbadini’s insecticidal protein operate by the pest ingesting them.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claims 33-35, 38-40, 42, 45, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (Huang) (US 2014/0047582 A1; published Feb. 13, 2014), Giacalone et al. (Giacalone) (US 2010/0112670 A1; published May 6, 2010), and Peterson et al. (Peterson) (US 2011/0203013 A1; published Aug. 18, 2011).
With regards to Claims 33-35, Huang discloses siRNA, miRNA, and amiRNA molecules having plant foot growth promoting activity, compositions comprising the same, and their uses (abstract; para.0004-0005, 0051-0058). The compositions and methods confer tolerance to biotic and abiotic stress and increase yield in plants by modulating gene-specific silencing. More particularly, the invention relates to contacting a small interfering RNA (siRNA) molecule with a plant or plant part to thereby promote root growth in the plant (para.0001, 0028, 0029).
With regards to Claim 38, increased abiotic stress tolerance and resistance, including enhanced drought tolerance, is correlated with increased root growth. Accordingly, the disclosed methods for promoting root growth are useful for conferring increased abiotic stress tolerance or resistance (para.0037-0041).
With regards to Claim 39, plants expressing siRNAs of the invention may also show increased yield, increased plant biomass, increased nutrient utilization, increased standability or resistance to wind stress, and other desirable agronomic indicators associated with increased root growth (para.0030).
Huang does not appear to explicitly disclose a minicell encapsulating a i) a nucleic acid that is capable of inducing RNA interference; and ii) a biologically active compound (Claim 33), or wherein the biologically active compound is a protein (Claims 40, 42, 45, and 46; elected species). Giacalone and Peterson are relied upon for these disclosures. The teachings of Giacalone are set forth above and incorporated herein. The teachings of Peterson are set forth herein below.
Peterson discloses compositions of interest to a plant cell (abstract; para.0001, 0003). In an embodiment, the compositions of interest for delivery to a plant cell are a polynucleotide and a polypeptide. The composition may be delivered as a complex, e.g., a protein-polynucleotide complex such as an RNA binding protein and the appropriate cognate polynucleotide (para.0073).
The polynucleotide for delivery to the plant cell may encode a polypeptide of interest which is expressed in the cell. The polynucleotide may encode a bioactive protein or polypeptide. The polynucleotide delivered to the plant cell may confer a particular trait of interest to the plant, for example, an agronomic trait. Examples of agronomic traits include yield, abiotic stress tolerance, drought tolerance, cold stress tolerance, heat stress tolerance, nitrogen utilization, seed set, seed size, plant height, and the like (para.0044-0045).
With regards to Claims 33, 40, 42, 45, and 46, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date to the combine the teachings of Huang and Giacalone and load Huang’s siRNA molecules into Giacalone’s minicell for delivery to plants to promote root growth in the plant, which in turn would increase abiotic stress tolerance of the plant (e.g., enhanced drought tolerance) and increase the plant yield, biomass, and nutrient utilization. One of ordinary skill in the art would have been motivated to do so as minicells allow for targeting of the delivery so that the payload is preferentially delivered to the target (e.g., plant). One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Huang is directed to the delivery of siRNA molecules to plants, and Giacalone discloses that minicells are known to encapsulate and deliver RNA to any organism.
Further, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of Huang and Giacalone with the teachings of Peterson and further encapsulate Peterson’s protein-polynucleotide complexes, such as an RNA binding protein and the appropriate cognate polynucleotide into the minicell of the combined teachings of Huang and Giacalone discussed above. One of ordinary skill in the art would have been motivated to do so in order to confer beneficial agronomic traits to the plant, e.g., increased yield (Claim 46), abiotic stress tolerance, drought tolerance (Claim 45), heat stress tolerance (Claim 45), and nitrogen utilization (Claim 46), and provide different mechanisms of action for providing such benefits. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Giacalone discloses that minicells can encapsulate at least one biologically active compounds (e.g., proteins and nucleic acids), and both Huang’s and Peterson’s payload operate by delivery to the plant.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claims 33-35, 38-40, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (Huang) (US 2014/0047582 A1; published Feb. 13, 2014), Giacalone et al. (Giacalone) (US 2010/0112670 A1; published May 6, 2010), and Saunders et al. (Saunders) (The dsRNA binding protein family: critical roles, diverse cellular functions; published June 2003).
With regards to Claims 33-35, Huang discloses siRNA, miRNA, and amiRNA molecules having plant foot growth promoting activity, compositions comprising the same, and their uses (abstract; para.0004-0005, 0051-0058). The compositions and methods confer tolerance to biotic and abiotic stress and increase yield in plants by modulating gene-specific silencing. More particularly, the invention relates to contacting a small interfering RNA (siRNA) molecule with a plant or plant part to thereby promote root growth in the plant (para.0001, 0028, 0029).
With regards to Claim 38, increased abiotic stress tolerance and resistance, including enhanced drought tolerance, is correlated with increased root growth. Accordingly, the disclosed methods for promoting root growth are useful for conferring increased abiotic stress tolerance or resistance (para.0037-0041).
With regards to Claim 39, plants expressing siRNAs of the invention may also show increased yield, increased plant biomass, increased nutrient utilization, increased standability or resistance to wind stress, and other desirable agronomic indicators associated with increased root growth (para.0030).
Huang does not appear to explicitly disclose a minicell encapsulating a i) a nucleic acid that is capable of inducing RNA interference; and ii) a biologically active compound (Claim 33), or wherein the biologically active compound is a protein (Claims 40 and 43; elected species). Giacalone, Saunders, and Peterson are relied upon for these disclosures. The teachings of Giacalone are set forth above and incorporated herein. The teachings of Saunders and Peterson are set forth herein below.
Saunders discloses that dsRNA binding proteins (DRBPs) are known to play essential roles in development, translation, RNA editing, and stability (abstract). HYL1, for example, is a DRBP that is a hormone signaling important for plant growth and development (p.965; p.971, Hyponastic leaves (HYL1)).
Peterson discloses that polypeptides, such as an RNA binding protein, are known to be delivered to plant cells (abstract; para.0068-0069).
With regards to Claims 33, 40, and 43, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date to the combine the teachings of Huang and Giacalone and load Huang’s siRNA molecules into Giacalone’s minicell for delivery to plants to promote root growth in the plant, which in turn would increase abiotic stress tolerance of the plant (e.g., enhanced drought tolerance) and increase the plant yield, biomass, and nutrient utilization. One of ordinary skill in the art would have been motivated to do so as minicells allow for targeting of the delivery so that the payload is preferentially delivered to the target (e.g., plant). One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Huang is directed to the delivery of siRNA molecules to plants, and Giacalone discloses that minicells are known to encapsulate and deliver RNA to any organism.
Further, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of Huang and Giacalone with the teachings of Saunders and Peterson and further encapsulate Saunder’s dsRNA binding protein (DRBP) into the minicell of the combined teachings of Huang and Giacalone discussed above. One of ordinary skill in the art would have been motivated to do so in order to ensure proper plant growth and development, and provide different mechanisms of action for providing such benefits. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Giacalone discloses that minicells can encapsulate at least one biologically active compounds (e.g., proteins and nucleic acids), and Peterson discloses that RNA binding proteins are known to be delivered to plants.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
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.
Claims 33-37, 40, 41, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,193,439 B2 (USPN 439) in view of Beghyn et al. (Beghyn) (US 2012/0297501 A1; published Nov. 22, 2012) and Giacalone et al. (Giacalone) (US 2010/0112670 A1; published May 6, 2010).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims claim substantially similar and overlapping agricultural compositions comprising a minicell encapsulating an insecticidal protein toxin capable of controlling or killing a plant pest or a plant pathogen.
The primary difference between the instant claims and the cited claims of USPN 439 is the claims of USPN 439 do not appear to claim a nucleic acid that is capable of inducing RNA interference encapsulated within the minicell. Beghyn and Giacalone are relied upon for this disclosure. Their teachings are set forth above and incorporated herein.
One of ordinary skill in the art would have found it prima facie obvious before the effective filing date to combine the claims of USPN 439 with the teachings of Beghyn and Giacalone, and further encapsulate Beghyn’s interfering RNA molecules (e.g., RNA molecules disclosed by Beghyn) into the minicells of USPN 439. One of ordinary skill in the art would have been motivated to do in order to widen the scope of pests controlled and have different mechanisms of action at play to control pest infestation on plants. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Giacalone discloses that minicells can also encapsulate nucleic acids, such as RNA molecules.
Claims 33-37, 40, 41, 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,324,431 B2 (USPN 431) in view of Sabbadini et al. (Sabbadini) (US 2013/0337545 A1; published Dec. 19, 2013).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims claim substantially similar and overlapping agricultural compositions comprising a minicell encapsulating a nucleic acid that is capable of inducing RNA interference in an agricultural target pest.
The primary difference between the instant claims and the cited claims of USPN 431 is the claims of USPN 431 do not appear to claim the inclusion of an insecticidal protein toxin. Sabbadini is relied upon for this disclosure. The teachings of Sabbadini are set forth above and incorporated herein.
One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the claims of USPN 431 with the teachings of Sabbadini and further encapsulate Sabbadini’s insecticidal protein toxin into USPN 431’s claimed minicell. One of ordinary skill in the art would have been motivated to do so in order to widen the scope of pests controlled and to have different mechanisms of action at play to control pest infestation on plants. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Sabbadini discloses that insecticidal protein toxins are known to be encapsulated into minicells and delivered to the area of the infestation.
Conclusion
Claims 33-46 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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/MONICA A SHIN/Primary Examiner, Art Unit 1616