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 .
DETAILED ACTION
Status of the Application
Applicant has canceled the original claims 1-15 and submitted new claims 16-31 Claims 16-31 are pending and are currently under examination.
Information Disclosure Statement
The submission of the Information Disclosure Statements are in compliance with 37 CFR 1.97. The information disclosure statement has been considered by the examiner and signed copies have been placed in the file.
Compliance with Sequence Rules
The drawings are objected to because Figure 7 recites sequences that do not have the required sequence identifier as set forth in 37 CFR 1.821(a)(1) and (a)(2).
If these sequences are listed in the current Sequence Listing, then the Figures can be amended to include the appropriate SEQ ID NOS. Corrected drawing sheets in compliance with 37 CFR 1.121(d). Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Applicant can also submit a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
A complete response to this office action must correct the defects cited above regarding compliance with the sequence rules and a response to the action on the merits which follows. The aforementioned instance of failure to comply is not intended as an exhaustive list of all such potential failures to comply in the instant application. Applicants are encouraged to thoroughly review the application to ensure that the entire application is in full compliance with all sequence rules. This requirement will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-32 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 16 recites "the bacterium is engineered to express at least one of…" and then recites two different proteins options as (a) and (b). The problem with the claim is that the limitation is written such that the bacterium can have at least one but the recitation of “and” after (a) indicates the bacterium has both (a) and (b). This is indefinite because it is unclear if the bacterium has both (a) and (b) or can have (a) or (b). If the claim is intended to have both (a) and (b), then claim 22 would be considered a duplicate claim. The claim is interpreted such that the bacterium can have at least of one (a) or (b). Claims 17-32 are rejected as they depend from claim 16.
Claim Rejections - 35 USC § 103
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 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim interpretation:
Claims 16-31 recite “the bacterium is engineered to…” followed by specific methods of engineering. The claims are interpreted as a product by process claim and MPEP2113 states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”
The specification describes the engineered bacterium as comprising a therapeutic nucleic acid, HEN1 or dsRBP or both HEN1 and dsRBP, lacking a functional rnr gene and also having hylA, inv or TRBP and therefore the claims are interpreted as the claimed structure of the bacterium having the elements would be considered engineered and prior art with the claimed elements would anticipate the bacterium.
Claims 16-22, 28, 30 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keates et al. (Pharmacogenomics, 2007, 8:867-871), Okuda et al. (Enhanced gene delivery and/or efficacy by functional peptide and protein. Curr Top Med Chem. 2009;9(12):1098-1108 cited on IDS filed 05/01/2024) and Huang ("Unique 2′-O-methylation by Hen1 in eukaryotic RNA interference and bacterial RNA repair." Biochemistry 51.20 (2012): 4087-4095),
Regarding claims 16, 28, 30 and 31, Keates et al. highlights the problems with delivery of siRNA to cells (see page 868) and discloses a Transkingdom RNAi vector wherein the technology uses nonpathogenic E. coli comprising a prokaryotic promoter engineered to produce an shRNA from plasmid (TRIP) containing Inv which permits entry into cells and HlyA genes which permit escape of the shRNA (page 868), wherein one of the advantages of using bacteria as a delivery vector for siRNA include low cost, wherein tkRNAi bacteria are engineered to die rapidly after cellular invasion to release shRNA and allow the shRNA to reach the cytoplasm of the host cell (page 868). Keates et al. suggests that the tkRNAi platform can be used to silence genes in cancer and other diseases such as viral infections (See page 871). Keates et al. do not teach the Transkingdom RNAi vector comprises a dsRNA binding protein (dsRBP) or a methyltransferase HEN1.
Regarding claims 16-22, Okuda et al. teach (dsRBP) has been shown to regulate signaling events and gene expression in cells and demonstrates in a vector expressing a dsRBP and shRNA, shRNA had a higher stability in cells (see page 1104). Okuda et al. teach a typical dsRBP is TAR RNA-binding Protein TRBP (see Table 5 page 1105).
Huang teach methylation of the 3’ end of an RNA which is achieved by a methyltransferase HEN1 that is mechanistically distinct from other known RNA 2′-O-methyltransferases. In eukaryotic organisms, 3′-terminal 2′-O-methylation of small RNAs stabilizes these small RNAs for RNA interference (RNAi) (abstract). Huang describes a subfamily of Hen 1 such as Clostridum thermocellum (see Fig. 2). Haung teach the fate of a small RNA in vivo depends on the status of 2′-O-methylation at its 3′-terminal nucleotide and if the 2′-OH group is unmethylated, uridines can be added by a terminal nucleotidyl transferase in a template-independent manner on the 3′-end of the small RNA, leading the marked RNA to degrade (left). Haung teach Hen1 methylates the 2′-OH group at the 3′-terminal nucleotide of a small RNA, resulting in inhibition of uridylation and thus stabilizing the RNA (right) (Figure 3 and page 4090).
Because it was known that dsRBP can regulate gene expression in cells and impart higher stability for RNAi molecules in cells and because it was known that methylation of the terminal ends of RNA resulted in increased stability, it would have been obvious to combine the teachings of Keates et al., Okuda et al. and Huang et al. and add a dsRBP and Hen1 into the bacterial vector taught by Keates et al. It would have further been obvious to use a plasmid to express the dsRBP and it would have been predictable that the combination of known elements taught by the references would increase the stability of the RNAi molecule.
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed.
Claims 16, 19-21, 23-25, 28, 30 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keates et al. (Pharmacogenomics, 2007, 8:867-871), Okuda et al. (Enhanced gene delivery and/or efficacy by functional peptide and protein. Curr Top Med Chem. 2009;9(12):1098-1108 cited on IDS filed 05/01/2024), Vincent et al. ("Substrate recognition and catalysis by the exoribonuclease RNase R." Journal of Biological Chemistry 281.40 (2006): 29769-29775) and Chen et al. ("Elevation of RNase R in response to multiple stress conditions." Journal of Biological Chemistry 280.41 (2005): 34393-34396) and Chiu, Ya-Lin et al. ("siRNA function in RNAi: a chemical modification analysis." Rna 9.9 (2003): 1034-1048).
Regarding claims 16, 28, 30 and 31, Keates et al. highlights the problems with delivery of siRNA to cells (see page 868) and discloses a Transkingdom RNAi vector wherein the technology uses nonpathogenic E. coli comprising a prokaryotic promoter engineered to produce an shRNA from plasmid (TRIP) containing Inv which permits entry into cells and HlyA genes which permit escape of the shRNA (page 868), wherein one of the advantages of using bacteria as a delivery vector for siRNA include low cost, wherein tkRNAi bacteria are engineered to die rapidly after cellular invasion to release shRNA and allow the shRNA to reach the cytoplasm of the host cell (page 868). Keates et al. suggests that the tkRNAi platform can be used to silence genes in cancer and other diseases such as viral infections (See page 871). Keates et al. do not teach the Transkingdom RNAi vector comprises a dsRNA binding protein (dsRBP) or rnr genes.
Regarding claims 16 and 19-21, Okuda et al. teach dsRNA binding protein has been shown to regulate signaling events and gene expression in cells and demonstrates in a vector expressing a dsRBP and shRNA, shRNA had a higher stability in cells (see page 1104). Okuda et al. teach a typical dsRBP is TAR RNA-binding Protein TRBP (see Table 5 page 1105).
Because it was known that dsRBP can regulate gene expression in cells and impart higher stability for RNAi molecules in cells, it would have been obvious to combine the teachings of Keates et al. and Okuda et al. and add a dsRBP into the bacterial vector taught by Keates et al. It would have further been obvious to use a plasmid to express the dsRBP and it would have been predictable that the combination of known elements taught by the references would increase the stability of the RNAi molecule.
Regarding claims 23-25, the rnr gene is defined in the specification as encoding RNase R cold shock protein (00062). Vincent et al. found that RNase R can degrade structured RNAs, such as duplex RNAs in the overhang regions, and is the only RNase that is able to degrade through a duplex RNA without the aid of a helicase activity (see page 29769 second col.). Chen et al. teach RNase R is found in bacterium such as E.coli (abstract and page 34393). RNase activity, such as RNase H, is a well-known problem of degradation of RNAi when administered to cells since its discovery (see pages 1034-1034 Chiu et al.). It would have been obvious to modify the nucleic acid delivery vehicle to delete or downregulate any RNase gene to increase the stability of the nucleic acid in cells or in vivo.
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed.
Claims 16, 19-21 and 26-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keates et al. (Pharmacogenomics, 2007, 8:867-871), Okuda et al. (Enhanced gene delivery and/or efficacy by functional peptide and protein. Curr Top Med Chem. 2009;9(12):1098-1108 cited on IDS filed 05/01/2024), Wang et al. ("Intermonomer interactions in hemagglutinin subunits HA1 and HA2 affecting hemagglutinin stability and influenza virus infectivity." Journal of Virology 89.20 (2015): 10602-10611 cited on IDS filed 05/01/2024), Russell-Jones, G. J. ("The potential use of receptor-mediated endocytosis for oral drug delivery." Advanced drug delivery reviews 20.1 (1996): 83-97), Dehorn et al. ("Silencing viral infection." Plops medicine 3.7 (2006)) and as evidenced by Shim et al. ("Sublingual administration of bacteria-expressed influenza virus hemagglutinin 1 (HA1) induces protection against infection with 2009 pandemic H1N1 influenza virus." Journal of microbiology 51.1 (2013): 130-135).
Regarding claims 16, 28, 30 and 31, Keates et al. highlights the problems with delivery of siRNA to cells (see page 868) and discloses a Transkingdom RNAi vector wherein the technology uses nonpathogenic E. coli comprising a prokaryotic promoter engineered to produce an shRNA from plasmid (TRIP) containing Inv which permits entry into cells and HlyA genes which permit escape of the shRNA (page 868), wherein one of the advantages of using bacteria as a delivery vector for siRNA include low cost, wherein tkRNAi bacteria are engineered to die rapidly after cellular invasion to release shRNA and allow the shRNA to reach the cytoplasm of the host cell (page 868). Keates et al. suggests that the tkRNAi platform can be used to silence genes in cancer and other diseases such as viral infections (See page 871). Keates et al. do not teach the Transkingdom RNAi vector comprises a dsRNA binding protein (dsRBP).
Regarding claims 16 and 19-21, Okuda et al. teach dsRNA binding protein has been shown to regulate signaling events and gene expression in cells and demonstrates in a vector expressing a dsRBP and shRNA, shRNA had a higher stability in cells (see page 1104). Okuda et al. teach a typical dsRBP is TAR RNA-binding Protein TRBP (see Table 5 page 1105).
Because it was known that dsRBP can regulate gene expression in cells and impart higher stability for RNAi molecules in cells, it would have been obvious to combine the teachings of Keates et al and Okuda et al. and add a dsRBP into the bacterial vector taught by Keates et al. It would have further been obvious to use a plasmid to express the dsRBP and it would have been predictable that the combination of known elements taught by the references would increase the stability of the RNAi molecule.
Regarding claims 26 and 27, Wang et al. teach the importance of receptor-mediated endocytosis for oral drug delivery and teach use of a hemagglutinin such as HA1 binding to cells and allows uptake (see 10602-10603). Russell et al. teach the use of receptor mediated endocytosis for oral drug delivery (see page 83-85). As evidenced by Shim et al., HA1 is capable of being expressed from bacterial cells (see page 131). It would have been obvious to engineer the bacterial nucleic acid delivery vehicle of Keates et al. to expression HA1 on the service to deliver to cells to facilitate entry more efficiently.
Regarding claim 29, Dykxhoorn et al. teach RNAi can be used to suppress viral replication by targeting the gene such as HSV or parainfluenza (see pages 1000-1002). Dehorn et al. teach the key obstacle to harnessing RNAi as a treatment is getting the RNAs into cells in vivo (see 1003).
It would have been obvious to modify the bacteria to express HA1 to be able enhance delivery to cells and one of skill would have been capable as evidenced by Shim et al. who teach HA1 can be expressed in bacteria. Further it would have been obvious to use the nucleic acid delivery vector to target gene such as influenza genes as taught by Dehorn et al. given Keates et al. teach the bacterial nucleic acid delivery vehicle can silence genes in cancer and other diseases such as viral infections. One of skill in the art would have been capable of combining the references with a reasonable expectation of modifying the bacterial nucleic acid delivery vehicle.
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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
Claims 23-31 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
The written description requirement for a genus may be satisfied through sufficient description of a representative number of species 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 functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Thus when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The claims are drawn to a genus of nucleic acid delivery vehicles comprising a broad genus of bacteria, a prokaryotic vector, a broad genus of therapeutic nucleic acids, a methyltransferase or dsRBP or fragments/domains thereof, lacking a rnr gene, lacking a gene encoding a protein of RNase E, I, H or J, expresses hylA, inv gene and influenza virus hemagglutinin (HA1) with the function of exhibiting reduced nucleic acid degradation, increased nucleic acid stability, magnitude or duration of activity and reduced RNase activity.
The description of the claimed engineered bacteria in the specification is largely prophetic with a single example of a nucleic acid delivery vehicle of a single bacteria species comprising a siRNA and a methyltransferase HEN1 wherein it was shown that the siRNA was protected from RNase activity (see Fig 6 and [00037]). The specification does not describe any other nucleic acid vehicle methyltransferase or dsRBP or fragments/domains thereof, do not describe the engineered bacteria lacks a rnr gene, lacks a gene encoding a protein of RNase E, I, H or J, expresses hylA, inv and influenza virus hemagglutinin (HA1) with the function of exhibiting reduced nucleic acid degradation, increased nucleic acid stability, magnitude or duration of activity and reduced RNase activity.
The specification and claims do not indicate what distinguishing characteristics of the single engineered bacteria described in the specification that are concisely shared by the members of the broad genus that would convey to one of skill in the art that this engineered bacteria represent the entire genus. A review of the specification shows that it provides no description or guidance that would allow one of skill to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination. Thus the specification does not describe a representative number of species of the genus of the engineered bacteria as claimed with the functional characteristics as claimed.
The prior art describes a Transkingdom RNAi vector wherein the technology uses a single type of a nonpathogenic, E. coli, comprising a prokaryotic promoter engineered to produce an shRNA from plasmid (TRIP) containing Inv which permits entry into cells and HlyA genes which permit escape of the shRNA (see Keates et al. cited above). The prior art describes the role RNase R has against duplex RNAs. Vincent et al. (cited above) found that RNase R can degrade structured RNAs, such as duplex RNAs in the overhang regions, and is the only RNase that is able to degrade through a duplex RNA without the aid of a helicase activity (see page 29769 second col.). Chen et al. (cited above) teach RNase R is found in bacterium such as E.coli (abstract and page 34393).
The prior art does not describe using the vast number of bacterial nucleic acid delivery vehicles as claimed, the broad genus of nucleic acids, using any methyltransferase or dsRBP or fragments/domains thereof, does not describe the genus of bacteria lacking a functional rnr gene or expression HA1 protein with the claimed functions of exhibiting reduced nucleic acid degradation, increased nucleic acid stability, magnitude or duration of activity and reduced RNase activity from the broad genus of RNase known in the art.
Since the disclosure and the prior art fail to describe the common attributes and characteristics concisely identifying members of the proposed genus, and because the claimed genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus claimed.
“Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
"A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added).
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
Thus one of skill at the time of the invention could not have concluded that Applicant was in possession of the genus of bacterial nucleic acid delivery vehicles as claimed.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16-29 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 122-151 of copending Application No. 17,595,993 (App ‘993) in view of Falb2 (WO 2017123675 A1, published July 29, 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims of App ‘993 are an obvious variation/embodiment of the instantly claimed bacterial delivery vector comprising a nucleic acid.
Claims 167, 127, 132-135, 141, 142 and 146 overlap in scope with the instant claims.
Claims 122-125, 128-131, 136-140, 143-145, of App ‘993 claim a gene editing nuclease and a guide RNA. Falb2 teaches genetically engineered bacteria for delivering a payload, including a CRISPR-regulated genetic circuit ([920]). Falb2 teaches bacteria comprising a Cas9 protein (i.e., a CRISPR nuclease) and a gene encoding a guide RNA ([920]). Falb2 teaches bacteria can be used as delivery vectors, ([154]), which is term of art for the claimed invention. It would have been obvious for one of ordinary skill in the art to use the engineered vector of Keates et al. to deliver a gene editing nuclease and a guide RNA and one of skill in the art would had a reasonable expectation of success at expression of the gene editing nuclease and a guide RNA system.
Claims 147-151 of App ‘993 are drawn to methods of delivering the gene editing system to a target cell. It would have been obvious to use the instant engineered bacteria in view of Falb2 in methods of delivery to a cell. It would have been obvious to use in the methods of the instant claims. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application. Thus, the co-pending product could be used in the method of the instant claims.
This is a provisional rejection as the claims have not been patented.
Claims 16-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of Patent 11,312,954.
Claims of Patent ‘954 are drawn to a bacterium for nucleic acid delivery comprising promoters, invasion factors, promoters, a plasmid having less than 4700 base pairs and one or more sequences encoding therapeutic nucleic acids and a kit. The instant claims are drawn to bacterium for nucleic acid delivery comprising promoters, invasion factors, promoters, a plasmid having less than 4700 base pairs and one or more sequences encoding therapeutic nucleic acids wherein the bacterium can be any of Listeria, Yersinia, Rickettsia, Shigella, E. coli, Salmonella, Legionella, Chlamydia, Brucella, Neisseria, Burkolderia, Bordetella, Borrelia, Coxiella, Mycobacterium, Helicobacter, Staphylococcus, Streptococcus, Porphyromonas, Vibrio, Treponema, Lactobacillus, and Bifidobacteria..
The instant claims do not recite the bacterial plasmid as having less than 4700 in the claims but recite the same bacterium in claim 31 which would therefore be less than 4700 base pairs as in Patent ‘954.
Thus the claims not patentably distinct from each other.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636