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 .
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 3/7/2024 have been considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in paragraphs [0033, 0041, 0063 and 0118] of the instant published disclosure, USPgPub 2024/0254167. 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 is objected to for failing to adhere to the requirements of the sequence rules, see Figures 6A, 6B, and 7A-7C, for example, of the instant published disclosure. Applicant must append SEQ ID NOs. to all mentions of specific sequences comprising four or more amino acids and ten or more nucleic acids in the specification. When a sequence is presented in a drawing, the sequence must still be included in the sequence listing if the sequence falls within the definition set forth in 37 CFR 1.821(a), and the sequence identifier ("SEQ ID NO:X") must be used, either on the drawing itself or in the Brief Description of the Drawings. Applicant is required to append a SEQ ID NO. to any sequence applicable to the rule. See 37 CFR § 1.821 (a)-(d) and MPEP § 2422. Appropriate correction is required.
Applicant is reminded that the incorporation of essential material in the specification by reference to a foreign application or patent, or to a publication is improper. Instant paragraph [0001] of the instant published application states that “European Patent Application EP 21157234.2, filed on Feb. 15, 2021, the contents of all are hereby incorporated by reference”. Incorporation of essential material is improper under 37 CFR § 1.57(d). Applicant is required to amend the disclosure to include the material incorporated by reference. 37 CFR § 1.57. The amendment must be accompanied by an affidavit or declaration executed by the applicant, or a practitioner representing the applicant, stating that the amendatory material consists of the same material incorporated by reference in the referencing application. See In re Hawkins, 486 F.2d 569, 179 USPQ 157 (CCPA 1973); In re Hawkins, 486 F.2d 579, 179 USPQ 163 (CCPA 1973); and In re Hawkins, 486 F.2d 577, 179 USPQ 167 (CCPA 1973). Furthermore, if the recited materials in the instant claims, was not set forth in the specification as filed, and was not publicly available at the time the application was filed, the amendment will be treated as an attempt to introduce new matter (similar to attempts to incorporate essential material by reference to unpublished material).
The lengthy 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.
Claim Objections
Claim 6 is objected to because of the following informalities: The acronym, “M”, should be spelled out prior to fist use. It is presumed that “M cells” refer to microfold cells since the recited cells reside in the intestinal tract in paragraph [0073] of the instant published disclosure, USPgPub 2024/0254167, and described by Ma et al. (ref. 23 of the IDS). Appropriate correction is required.
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 1-15, 22-24, 26, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 requires deleting or inactivating at least one Clostridium gene to inactivate or attenuate at least one gene encoding a “toxic activity” and a “metabolic activity”. There is no discussion clarifying the intended meaning of the quoted terms. In what way is an activity toxic? Or, is the toxicity aimed at a specific animal? It is not clear what metabolic activity encompasses to since activity could mean an increase or decrease in any anaerobic fermentation process of carbohydrates or even genetic transcription. This rejection affects all dependent claims.
Claim 15 requires that the Clostridium strain is “a derivative” of C. butyricum or C. sporogenes, but it is not clear what is intended by “a derivative” of these Clostridium strains. Since Clostridium strains all have features in common that identify them as a Clostridium strain, “a derivative” is not specific or clear.
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.
Claims 1-15, 22-24, 26, and 27 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. This is a written description rejection.
Claim 1 requires a genetically modified Clostridium strain expressing at least one recombinant antigen, modified to inactivate or attenuate (a) at least one Clostridium gene encoding a toxic activity; and (b) at least one Clostridium gene encoding a metabolic activity. Therefore, claim 1 asserts that any single Clostridium strain selected for modification possesses at least one gene encoding a toxic activity and at least one Clostridium gene encoding a metabolic activity. Paragraph [0040] of the instant published disclosure, USPgPub 2024/025167, states:
[0040] “CLOSTRA” refers to any species, strain, isolate, variant, and cells identified as belonging to the Clostridium genus that present sporulation and germination control in organisms, for example, being directly isolated from organisms and biological samples, or obtained from public sources, including repositories and cell banks. A non-exhaustive list of such specific Clostridium species includes C. (Clostridium) butyricum, C. sporogenes, C. novyi, C. difficile, C. perfringens, C. botulinum, and any isolate or strain found in repositories and cell banks, described in the literature, and/or commonly used in industrial or clinical applications. Additional details and classifications pertaining to Clostridium species to be used as CLOSTRA can be found in the scientific literature (Cruz-Morales P et al., 2019). Moreover, a CLOSTRA strain can be any of recombinant, laboratory Clostridium strains that is indicated as CLOSTRA, CLOSTRA-A, CLOSTRA-S, CLOSTRA-T, and strains derived from them that are described in PCT/EP2020/087338.
According to Schoch CL, et al. NCBI® Taxonomy: a comprehensive update on curation, resources and tools. Database (Oxford). 2020: baaa062.
(https://www.ncbi.nlm.nih.gov/taxonomy/Browser), there are over 200 recognized Clostridium strains. However, contrary to claim 1’s assertion, not all Clostridium strains possess at least one gene having a toxin. Camorlinga et al. (Frontiers in microbiology. 2019 Feb 1; 10:84) review naturally-occurring non-toxigenic C. difficile strains with enlarged colony morphology, a high resistance to metronidazole, and increased sporulation efficiency, corresponding to metabolic activity, recited in claim 1 and sporulation inducement recited in claim 6. Non-toxic C. difficile strains would not possess a gene encoding a toxic activity. The only example of metabolic activity provided in the instant disclosure is synthesizing uracil in paragraph [0019, for example]. The myriad activities of the entire Clostridium genus members’ metabolism and associated genes have not been identified and have no written description. Riedel et al. (International Journal of Medical Microbiology. 2017; 307: 311-320) describe growth behavior, motility and fermentation product formation of 17 different C. difficile isolates (which the claims are not limited to). Riedel et al. conclude toxin formation is correlated with metabolism, but that metabolism-associated fermentation pathways were highly varied between isolates, see the abstract, Figures 3 and 5, and Tables 3 and 4. The logarithmic quantity of possible genes encoding any protein or regulatory sequence contributing to toxicity and metabolism in any Clostridium strain, required by the claims, are not supported by the instant disclosure. A definition by function alone “does not suffice, to sufficiently describe a coding sequence “because it is only an indication of what the gene does, rather than what it is.” Eli Lily, 119 F.3 at 1568, 43 USPQ2d at 1406.
The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004). To provide adequate written description and 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.
Example 1, beginning on page 17 of the instant published disclosure, describes recombinantly modifying C. sporogenes and C. butyricum strains to generate “CLOSTRAV-BTA” strains comprising a fusion protein that is secreted in paragraph [0014, for example] and lacking toxicity in humans or animals in paragraph [0017, for example]. However, the instantly modified C. sporogenes and C. butyricum strains do not represent the broad genus of Clostridium members listed by Schoch CL, et al. NCBI® Taxonomy. Regarding the breadth of toxicity genes claimed, the Sag operon, is the only gene described in paragraph [0049]. Uracil autotrophy is the only metabolic gene also discussed in paragraph [0049]. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of Clostridium strains possessing toxicity and metabolic genes that can modified, or the vast quantity of Clostridium genes associated with toxicity and metabolism. For these reasons, the skilled artisan would be unable to recognize a Clostridium strain and toxic and metabolic genes to be modified, as required.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, 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 the inventors invented what is claimed. As discussed above, the skilled artisan cannot envision the distinguishing, identifying characteristics of the encompassed genus of Clostridium, toxic, and metabolic genes claimed. The claims do not meet the written description provision of 35 U.S.C. 112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claims 22-24, 26, and 27 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 22-24 and 26 are drawn to a method of treating or preventing a (any) disease by administering a pharmaceutical composition comprising a genetically modified Clostridium strain expressing at least one recombinant antigen and presenting one or more additional genome modifications for deleting and/or to inactivating at least one Clostridium gene, wherein said strain is modified to inactivate or attenuate: a) at least one Clostridium gene encoding a toxic activity; and b) at least one Clostridium gene encoding a metabolic activity. Claim 27 requires that the administered composition is a vaccine. However, there is no working example provided in the disclosure demonstrating treating or preventing any disease in any subject with the instant composition claimed. The skilled artisan would not predict that the instant composition would be useful as a vaccine or efficacious in the method claimed. Figure 2 of Pollard et al. (Nature Reviews Immunology. 2021 Feb; 21 (2) :83-100) provides a list of vaccine types. All of the vaccines depicted include a pathogen-specific antigen or a nucleic acid encoding an antigen from a specific pathogen. Instant claim 23 requires that the disease prevented or treated is an infectious disease and claim 24 lists the infectious disease as COVID-19, but the “recombinant antigen” recited in line 2 of claim 1 is not pathogen- or COVID-19-specific. Furthermore, there is no indication in Pollard et al. that any of the pathogen-specific vaccines would be efficacious against “any” disease or a disease caused by a different pathogen from the one the vaccine is specific for. For these reasons, it is determined that the claims would require an undue quantity of experimentation to use the invention claimed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7, 8, 15, 26, and 27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kubiak (WO 2021/123391).
The applied reference has a common inventor, Kubiak, with the instant application. Based upon the earlier effectively filed date of the reference (December 18, 2019), it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Kubiak anticipates a genetically modified Clostridium strain expressing a heterologous gene encoding an antigen, see claims 1 and 6. The Clostridium strain is modified to inactivate or attenuate at least one gene in haemolysis and metabolism, see claims 8 and 9. These claims of Kubiak anticipate instant claims 1 and 2. Claim 10 of Kubiak anticipates the Clostridium strain is a uracil auxotroph, as required by instant claim 3. Claims 3, 4, 11, and 12 of Kubiak anticipate the Clostridium strain modified to present an inducible or repressible sporulation phenotype, anticipating instant claim 4. Table 8, paragraph [0110] of Kubiak lists signal sequences fused to IL-2, anticipating instant claim 5. Paragraphs [0106-0109] lists multiple heterologous coding sequences and signal sequences that can be integrated into the Clostridium genomes, anticipating instant claim 7. Paragraphs [0015 and 0077] of Kubiak teach the recombinant antigen is from a virus to vaccinate and immunize against such virus, anticipating instant claims 8 and 27. Claim 5 of Kubiak anticipates the C. butyricum, C. sporogenes strains of claim 15. Claim 14 of Kubiak anticipates a pharmaceutical composition of instant claim 26.
Claims 1, 4-6, 8, 26, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (Virology. 2004; 329: 226–233).
Chen et al. anticipate a non-toxigenic Clostridium strain, modified to remove the cpe toxicity region and expressing a SIV p27 as a fusion protein, CPE (enterotoxin/ adjuvant)-27, as a vaccine composition, see the title, abstract, and “Construction of a recombinant C. perfringens vaccine strain carrying SIV p27 gene”. Under “Expression of the CPE–SIV p27 fusion protein by the recombinant C. perfringens vaccine construct”, Chen et al. describe cpe promoter functions during sporulation in MDS to promote sporulation, anticipating genetic modification of metabolic activity. These teachings anticipate claims 1, 4, 5, 8, 26, and 27. In “Detection of intact SIV p27 fusion protein in terminal ileum of mice following oral feeding”, Chen et al. anticipate delivery of C. perfringens to M cells, as required by instant claim 6.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. supra and Nariya et al. (Applied and Environmental Microbiology. Feb 2011; 77 (4): 1375–1382).
See the teachings of Chen et al. above. Chen et al. do not teach the Clostridium strain is modified to inactivate or attenuate at least one gene for hemolysis.
Nariya et al. teach recombinantly modifying Clostridium genes to remove or reduce hemolytic toxin activity, see the abstract, “Sextuple disruptant of strain HN13”, the “H1314” mutant, and Figure 6.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have deleted the hemolytic genes, taught by Nariva et al., in the Clostridium of Chen et al. to remove hemolytic toxicity and allow efficient counterselection, see the abstract and the first paragraph of the first column on page 1381. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have deleted the hemolytic genes, taught by Nariva et al., in the Clostridium of Chen et al. because both Nariva et al. and Chen et al. recombinantly modify C. perfringens to render it non-toxic, see “Construction of a recombinant C. perfringens vaccine strain carrying SIV p27 gene” of Chen et al. and the abstract, “Sextuple disruptant of strain HN13”, the “H1314” mutant, and Figure 6 of Nariya et al.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. supra, Heap et al. (Oncotarget. 2014 Jan 12; 5 (7): 1761-1769), and Lopez Ferreira et al. (USPgPub 2019/0367947).
See the teachings of Chen et al. above. Chen et al. do not teach the Clostridium as defective in synthesizing uracil.
Heap et al. teach making Clostridium a uracil autotroph, see the abstract and “Construction of recombinant C. sporogenes”.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have made the Clostridium of Chen et al. a uracil autotroph, as taught by Heap et al., to circumvent the need for a selective marker and disable the strain, see the paragraph above, “Strain characterization in vitro”. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have made the Clostridium of Chen et al. a uracil autotroph, as taught by Heap et al. because Lopez Ferreira et al. teach modification of the upp gene (identified as uracil phosphoribosyltransferase in paragraph [0049] of the instant published disclosure), is not essential and is successfully used in other Clostridium species, see Figure 19 and paragraphs [0307, 0343, and 0357].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. supra and Burman et al. (WO 01/94599).
See the teachings of Chen et al. above. Chen et al. d not teach expressing two or more antigens in one or more fusion proteins.
Burman et al. teach Clostridium expressing a heterologous polypeptide fused to an S-layer protein and fusion polypeptides, see page 5, lines 19-23; page 7, lines 21-23; page 8, lines 3-21; claims 1, 9, 12, 18, and 21.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have expressed multiple fusion proteins, as taught by Burman et al., in the Clostridium of Chen et al. to induce an immune response against multiple antigens, see page 8, lines 3-21 and Figure 6. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have expressed multiple fusion proteins, as taught by Burman et al., in the Clostridium of Chen et al. because Burman et al. teach any Clostridium strain, including C. perfringens, is encompassed on page 21, lines 18-20 and page 22, lines 3-33.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. supra, instant SEQ ID NO: 11 alignment with Geneseq database access no: BHU92053 Jul 2020, and Lee et al. (Journal of Virology. April 2006; 80 (8): 4079-4087).
See the teachings of Chen et al. above. Chen et al. do not teach or suggest expressing an antigen from SARS-CoV-2 spike RBD1 protein comprising SEQ ID NO: 11.
Geneseq database access no: BHU92053 shares 100% sequence identity to instant SEQ ID NO: 11, see the alignment provided.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have replaced the SIV p27 portion of Chen et al. with Geneseq db access no BHU92053 to induce an immune response against SARS-CoV-2, see the description accompanying the alignment. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have replaced the SIV p27 portion of Chen et al. with Geneseq db access no BHU92053 to induce an immune response against SARS because Lee et al. teach mucosal immunization with a surface-displayed SARS spike protein on Lactobacillus, also a gram-positive anaerobic rod-shaped bacteria common to the mammalian gastrointestinal tract.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al., Burman et al., Geneseq database access no: BHU92053, and Lee et al. and as applied to claims 1, 4-11, 26, and 27 above, and further in view of instant SEQ ID NO: 17 alignment with Geneseq db access no BIS89424 4-Feb-2021.
See the teachings of Chen et al., Burman et al., Geneseq database access no: BHU92053, and Lee et al. above. None of the references teach or suggest expressing a nucleocapsid from SARS-CoV-2 comprising SEQ ID NO: 17.
Geneseq db access no BIS89424 shares 100% sequence identity with instant SEQ ID NO: 17.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have expressed Geneseq db access no BIS89424 as an additional antigen in the recombinant Clostridium of Chen et al., Burman et al., Geneseq database access no: BHU92053, and Lee et al. to induce an immune response against the nucleocapsid of SARS-CoV-2. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have included Geneseq db access no BIS89424 as an additional antigen in the recombinant Clostridium of Chen et al., Burman et al., Geneseq database access no: BHU92053, and Lee et al. because Burman et al. teach Clostridium expressing multiple antigens, see page 5, lines 19-23; page 7, lines 21-23; page 8, lines 3-21; claims 1, 9, 12, 18, and 21.
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 1-4, 8, 15, 26, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 6, 8-10, and 14 of copending Application No. 17/787,381 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, and 6 of ‘381 anticipate a genetically modified Clostridium strain expressing at least one recombinant antigen and presenting one or more additional genome modifications for deleting and/or to inactivating at least one Clostridium gene encoding hemolysis; at least one Clostridium gene encoding a metabolism gene; and inducible or repressible sporulation phenotype, required in instant claims 1, 2, and 4. Claim 10 of ‘381 anticipates the Clostridium as a uracil autotroph, anticipating instant claim 3. Claim 9 of ‘381 states that the heterologous gene encodes a virus protein, anticipating instant claim 8. Claim 15 of ‘381 states that the Clostridium strain is a derivative from C. butyricum or C. sporogenes, anticipating instant claim 5. Claim 15 of ‘381 anticipates the composition as therapeutic, anticipating instant claims 26 and 27. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
The prior art does not teach or suggest SEQ ID NOs: 28-32.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Shanon A. Foley/ Primary Examiner, Art Unit 1671