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 .
Status of Claims
The amendment filed on 12/09/2025 amended claims 240 and 242. Claims 1-239 were previously cancelled. Claims 240-259 are pending and will be examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/05/2026 was filed after the mailing date of the Office Action on 10/30/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 12/09/2025 in response to the office action mailed 10/30/2025 is acknowledged. The claim objections are withdrawn for the following reasons:
Applicant has shown the species share a substantial structural feature and a common use to su(a conserved targeting sequence for localization to the exosporium) and is therefore a proper Markush grouping.
Maintained or modified rejections are set forth below, as necessitated by the amendments. Responses to arguments follow.
Maintained Claim Rejections - 35 USC § 112(a) - Modified as Necessitated by Claim Amendments
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 240-259 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. This is a written description rejection.
Claims 240-259 recite plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising one of eight recited sequences.
Claims are interpreted to encompass any fusion protein having plant pathogen resistance and a targeting sequence that is recited in claim 240.
The Written Description Guidelines for examination of patent applications indicates, “the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure or relevant, identifying characteristics, i.e., structure or other physical characteristics and/or other chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show Applicant was in possession of the claimed genus.” (See MPEP 289).
The specification and claims do not indicate what distinguishing attributes are shared by the members of the genus. Thus, the scope of the claims includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, "protects a plant from a pathogen" alone is insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, applicant was not in possession of the claimed genus.
Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. The protein itself is required. See Fiers v. Revel, 25 USPQ 2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts., 18 USPQ2d 1016.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 111, 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." The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed."
Applicant is reminded that Vas-Cath make clear that the written description provision of 35 USC 112 is severable from its enablement provision.
Furthermore, in The Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus by only their functional activity does not provide an adequate written description of the genus. The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of DNA molecules, usually defined by a nucleotide sequence, falling within the scope of the claimed genus. At section B(1), the court states that "An adequate written description of a DNA... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention."
“A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when…the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
Further, it is not sufficient to define it solely by its principle biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. Per the Enzo court’s example (Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched “in terms of its function of lessening inflammation of tissues” which, the court stated, “fails to distinguish any steroid from others having the same activity or function” and the expression “an antibiotic penicillin” fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function in insufficient for written description, isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Therefore, only recombinant Bacillus cereus family members with defined proteins or peptides that protect a plant from a pathogen in combination with a recited targeting sequence meet the written description provision of 35 USC § 112, first paragraph.
Response to Arguments
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive.
Applicant argues that both the genus “targeting sequences” and the genus “protein or peptide that protects a plant from a pathogen” are both adequately supported. Applicant states that the amendments to the claims, which further define the targeting sequence, result in the rejection relying on subject matter no longer encompassed by the claims and so the rejection is moot. Applicant argues that the specification describes a structural feature common to the members of the genus of “targeting sequences or exosporium proteins” so that one of skill in the art can visualize or recognize the members of the genus. Applicant argues that “proteins or peptides that protects a plant from a pathogen” were well known within the art at the time of filing, and so do not need to be described. Applicant argues that the examples in the specification, specifically paragraph [0008], are sufficient to represent the genus.
Examiner agrees that the amendments to the claims have clarified the “targeting sequences”. Therefore, the written description rejection no longer encompasses the portion of the fusion protein that comprises a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising one of the recited sequences. However, Examiner maintains that there is not sufficient written description for a “protein or peptide that protects a plant from a pathogen”. Applicant’s argument that all “proteins or peptides that protect a plant from a pathogen” are well known within the art is not persuasive and unsupported by evidence. With the broad definition of “a protein or peptide that makes a plant exposed to the protein or peptide less susceptible to infection with a pathogen”, Applicant is claiming a broad genus of proteins with no common structure. Applicant lists Dunne et al. (2000) and Yen et al. (2006) as references that show “extensive knowledge in the part of anti-pathogenic proteins and peptides, their structures, and their effects on plants”. However, the Dunne et al. references names one fungicidal protease, and the Yen at al. reference names a different antifungal protease. Two species are not enough support to demonstrate “extensive knowledge” in the art. Moreover, both of these references only teach one type of anti-pathogenic protein; a protease, that only works against fungi, not bacteria, viruses, parasites, worms, insects, or other pathogens.
Applicant points to the specification, paragraph [0008], as providing exemplary proteins and peptides that protect a plant from a pathogen, including a harpin, an a-elastin, a 3-elastin, a systemin, a phenylalanine ammonia-lyase, an elicitin, a defensin, a cryptogein, a flagellin protein, a flagellin peptide, a bacteriocin, a lysozyme, a lysozyme peptide, a siderophore, a non-ribosomal active peptide, a conalbumin, an albumin, a lactoferrin, a lactoferrin peptide, or TasA. The section of the specification titled “proteins and peptides that protect a plant from pathogens”, beginning page 45 and paragraph [00110] also recites that the proteins may also be toxins, proteases, lactonases, and more. The art of Dunne et al. and Yen et al. do not provide sufficient species to encompass a genus that includes all these recited proteins or peptides. Thus, the claim that recites “proteins and peptides that protect a plant from a pathogen” is drawn to an extremely broad genus with many different mechanisms of action and is not sufficiently supported as well known in the art. No one person of skill in any art would be familiar with every protein or peptide that could protect a plant from a pathogen. Moreover, as of yet undiscovered proteins may also protect plants from pathogens; these would not be known in the art at the time of filing.
Given that the claims recite an extremely broad genus, and define said genus only by the function of “making a plant exposed to the protein or peptide less susceptible to infection with a pathogen”, MPEP §2163 requires Applicant to show a representative number of species by reduction to practice or disclosure of common structure.
Applicant does not appear to disclose any amino acid or nucleic acid sequences encoding the claimed “proteins or peptides that protects a plant from a pathogen.” Applicant only reduces to practice, in the examples, antimicrobial peptides LfcinB and LysM (example 15, paragraph [00258] and a glucanase (example 17, paragraph [00262]). Applicant does not appear to provide a SEQ ID NO for these proteins or point to a source that would contain the sequence of these proteins. These examples are not sufficient to encompass the entire genus of “proteins or peptides that protects a plant from a pathogen”. As there would be substantial variation among the broad genus, and applicant has not provided a common structural feature or reduction to practice of a representative number of species, Applicant has not shown a sufficient variety of species to reflect the variation within the genus. Therefore, Applicant’s argument that all sequences encompassed by “proteins or peptides that protects a plant from a pathogen” are well known in the art and the specification provides sufficient written description is not found convincing.
New Claim Rejections - 35 USC § 112(b) - Necessitated by Claim Amendments
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 244 and 257 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 244 is dependent on claim 240, which recites that the claimed fusion protein comprises “a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising: (a) an amino acid sequence having at least about 43% identity with amino acids 20-35 of SEQ ID NO: 1, wherein the identity with amino acids 25-35 is at least about 54%; (b) a targeting sequence comprising amino acids 1-35 of SEQ ID NO: 1; (c) a targeting sequence comprising amino acids 20-35 of SEQ ID NO: 1; (d) a targeting sequence comprising SEQ ID NO: 1; (e) a targeting sequence comprising SEQ ID NO: 60; (f) a targeting sequence comprising amino acids 22-31 of SEQ ID NO: 1; (g) a targeting sequence comprising amino acids 22-33 of SEQ ID NO: 1; or (h) a targeting sequence comprising amino acids 20-31 of SEQ ID NO: 1”. The broadest reasonable interpretation of claim 240 is that the fusion protein comprises a targeting sequence or exosporium protein that is selected from one of these eight options (a)-(h). Claim 244 recites that the fusion protein comprises options (a)-(br), a list of 70 possible targeting sequence options. It is unclear if the targeting sequences in claim 244 are contained within all the targeting sequences recited in claim 70, and therefore claim 244 is further specifying possible sequences, or if claim 244 is reciting a second targeting sequence or exosporium protein to be included within the fusion protein (rendering the claim indefinite as neither claim 240 or 244 recite more than one targeting sequence or exosporium protein), or if claim 244 is simply reciting additional sequences that comprise the only targeting sequence or exosporium protein in the fusion protein (therefore expanding the scope of claim 240). As such, one of skill in the art would not be able to properly identify the scope of the claim. Appropriate clarification and/or correction is required.
Claim 257 recites the limitation "the enzyme" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 257 depends from claim 246, which depends from 240. Neither claim 246 nor 240 recite an enzyme.
New Claim Rejections - 35 USC § 112(d) - Necessitated by Claim Amendments
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 244 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 244 is dependent on claim 240. As stated above, the broadest reasonable interpretation of claim 240 is that the fusion protein comprises a targeting sequence or exosporium protein that is selected from one of eight options (a)-(h). Claim 244 recites that the fusion protein comprises options (a)-(br), or 70 options. The broadest reasonable interpretation of claim 244 is that the fusion protein comprises a targeting sequence or exosporium protein that is selected from these 70 options. Therefore, claim 244 expands the scope of claim 240, and does not further limit it. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Maintained Rejections: Double Patenting - Modified as Necessitated by Claim Amendments
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 240-259 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,882,829. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising one of the recited sequences are anticipated by the claims of ‘829 drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member selected from one of the recited sequences. (See claims 19-21).
Claims 240-259 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,779,542. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising one of the recited sequences are anticipated by the claims of ‘829 drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member selected from one of the recited sequences. (See claims 19-22).
Claims 240-259 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,349,660. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising one of the recited sequences are anticipated by the claims of ‘829 drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member selected from one of the recited sequences. (See claims 19-22).
Claims 240-259 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 9,850,289. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising one of the recited sequences are anticipated by the claims of ‘829 drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member selected from one of the recited sequences. (See claims 5, 19 and 23-26).
Claims 240-259 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of U.S. Patent No. 9,573,980. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising one of the recited sequences are anticipated by the claims of ‘829 drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member selected from one of the recited sequences. (See claims 1-6).
Claims 240-259 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-159 of U.S. Patent No. 9,845,342. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising one of the recited sequences are anticipated by the claims of ‘829 drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member selected from one of the recited sequences. (See claims 18-22, 34, and 42).
Claims 240-259 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-72 of U.S. Patent No. 10,407,472. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising one of the recited sequences are anticipated by the claims of ‘829 drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member selected from one of the recited sequences. (See claims 1, 12-14, and 68).
Claims 240-259 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,836,800. A Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly filed claims drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member comprising one of the recited sequences are anticipated by the claims of ‘829 drawn to plant seeds coated with a recombinant Bacillus cereus family member, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising at least one protein or peptide that protects a plant from a pathogen and a targeting sequence or exosporium protein that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member selected from one of the recited sequences. (See claims 7-9, 11, 36-37).
Response to Arguments
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive.
Applicant traverses the double patenting rejections, but does not make any arguments against them, and therefore the rejections are upheld. Applicant also states that Terminal Disclaimers will be submitted as appropriate upon indication of otherwise allowable subject matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia Stephens whose telephone number is (571)272-1006. The examiner can normally be reached M-F 8-5 EST.
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, Anne Gussow can be reached at (571) 272-6047. 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.
/AMELIA STEPHENS/Examiner, Art Unit 1645
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
Prosecution Insights