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 .
Priority
This application has an effective filing date of March 18, 2024.
Status of the claims
Claims 1, 5-7, 10-15, 17-19, 21, 22 and 25-28 are pending. Claims 26-28 have been withdrawn by the applicant. Claims 1, 5-7, 10-14 and 22 have been amended.
The instant claim listing fails to comply with 37 CFR 1.121(c)(2), which states: All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of "currently amended," and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. [Emphasis added]. The current claim listing should not comprise the underlining of the previous claim amendments. Correction is required.
Applicant’s election without traverse of Group II, claims 1, 4, 15, 17-19, 21-22 and 25 in the reply filed on January 28, 2026 is acknowledged. Claims 5-7 and 10-14 have been amended to depend from claim 1 and are included in the election. Accordingly, 1, 4-7, 10-15, 17-19, 21-22 and 25 are under examination.
Trademark and Trade Names
The use of the terms for various reporter and quencher molecules, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following each term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Specifically, the trademarks FALCON TUBES, PLURISTRAINER, MACEROZYME RS, MILLIPORE STERILFLIP-GP, and numerous others, appear in the specification, at least, at paragraphs [0449, 0466, and 477]. These trademarks and all others must be properly represented. Correction is required.
Claim interpretation
Prior to analysis of the art, the claims must be construed. As noted in MPEP 2111, citing Phillips v. AWH Corp., 415 F.3d l303, 75 USPQ2d l321 (Fed. Cir. 2005), "During patent examination, the pending claims must be 'given their broadest reasonable interpretation consistent with the specification.' ". As pointed out, see In re Mott, 190 U.S.P.Q. 536 (CCPA 1975), "Claims must be given broadest reasonable construction their language will permit in ex parte prosecution, and applicant who uses broad language runs the risk that others may be able to support.”
The term “edited xxx1 plant” is known in the art to refer to a genetically modified genome that does not comprise non-native genetic elements. The term is not specifically defined in the specification. The art recognized definition of a gene-edited plant encompasses crops modified using techniques such as CRISPR-Cas9 to enhance or modify traits, such as disease resistance, yield and morphological changes without the introduction of non-native DNA. A gene-edited plant differs from a trans-genetically modified plant in that the edited plants mimic natural mutations. The term as used herein, however, does not mean that the claimed plant is not transgenic, it clearly comprises several genetic elements from Oryza sativa that are non-native sequences, but refers to several sequence ID which are described as “gene edited.” These include the 8th sequences comprising SEQID NO’s 227 or 228 or 229 and a 9th sequence comprising SEQ ID NO’s 219 or 225.
The phrase “nucleic acid construct” is a term of art known to mean an engineered, artificial segment of genetic material designed for research, biotechnology, or gene therapy. It combines specific functional elements—such as promoters, coding sequences (transgenes), and terminators—into a vector for introduction into cells to express, inhibit, or study specific genetic functions. Accordingly, a construct does not encompass within its means the natural or native genomic DNA of an organism, it is distinct, separate and unique from that of the native plant.
Claim 1, subsection k), recites combinations thereof. The elements which are combinable are listed below:
encoding a Bcl-2 associated athanogene (BAG) family molecular chaperone regulator 1 protein
encoding at least a first antimicrobial peptide;
encoding at least a first betalain biosynthesis protein
encoding a Solanum sogarandinum-derived glycosyltransferase 1 (SsGT1) protein
encoding an OsXa4 protein;
encoding an OsUMP 1 protein;
encoding an OsTPS19 protein
comprising at least a first DMR6 locus comprising SEQ ID NO:227, SEQ ID NO:228 or SEQ ID NO:229 that has been gene edited
comprising at least a first ATG8f locus comprising SEQ ID NO:226 that has been gene edited
comprising at least a first RGA2 promoter locus comprising SEQ ID NO:219 or SEQ ID NO:225 that has been gene edited or
combinations thereof, wherein the first, second, third, fourth, fifth or sixth nucleic acid sequence is operably linked to a heterologous or gene edited promoter, and wherein the banana plant exhibits increased resistance to Fusarium oxysporumf sp. cubense Tropical Race 4 (TR4) compared to a banana plant lacking the nucleic acid construct.
Since the limitation of “combinations thereof” is open-ended the subject matter encompassed by the claim can have any or all of the recited elements. Therefore, the transgenic or edited Banana plant may comprise any combinations of these elements.
Claim objection
The use of parenthetical notation in a claim should be avoided. In claim 1, the phrase “a first nucleic acid sequence encoding a Bcl-2 associated athanogene (BAG) family molecular chaperone regulator 1 protein” and the phrase “resistance to fusarium oxysporum f.sp.cubense Tropical race 4 (TR4)” introduce ambiguity as to the precise meaning of the claim. Parenthetical notation is preferably used to refer to reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m). However, when not referring to reference characters the scope of the claim can be misinterpreted. In this instance reference to (BAG) and (TR4) are interpreted as abbreviations and not further limitations of the preceding text. The abbreviation BAG refers to Bcl-2 associated athanogene and TR4 to Tropical Race 4 of the Fusarium oxysporum Ff.sp cubensse gene.
USC 112b
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, 4-7, 10-15, 17-19, 21-22 and 25 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.
The preamble of claim 1 states: “A transgenic or edited banana plant comprising a nucleic acid construct comprising:” As explained in the section on claim interpretation, the terms transgenic and edited are separately exclusive, a transgenic plant comprises nucleic acid sequences not native to the plant genome, while an edited plant comprises modification of the native plant genome sequences. The instant invention comprises a single plant that is both transgenic and edited, the preamble requires that the plant be either transgenic or edited. Applicants can obviate this rejection by amending the claims to refer to a “transgenic edited” plant or similar language with reflects the actual organism’s properties. Note, new matter must be avoided.
35 USC 112a
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, 4-7, 10-15, 17-19, 21-22 and 25 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.
Claim 1 recites a transgenic or edited banana plant comprising a nucleic acid construct comprising 10 elements. Since all the pending claims depend from claim 1, either directly or indirectly, claims 4-7, 10-15, 17-19, 21-22 and 25 are encompassed by this rejection. The constructs each comprise a sequence:
encoding a Bcl-2 associated athanogene (BAG) family molecular chaperone regulator 1 protein
encoding at least a first antimicrobial peptide;
encoding at least a first betalain biosynthesis protein
encoding a Solanum sogarandinum-derived glycosyltransferase 1 (SsGT1) protein
encoding an OsXa4 protein;
encoding an OsUMP 1 protein;
encoding an OsTPS19 protein
comprising at least a first DMR6 locus comprising SEQ ID NO:227, SEQ ID NO:228 or SEQ ID NO:229 that has been gene edited
comprising at least a first ATG8f locus comprising SEQ ID NO:226 that has been gene edited
comprising at least a first RGA2 promoter locus comprising SEQ ID NO:219 or SEQ ID NO:225 that has been gene edited or
combinations thereof, wherein the first, second, third, fourth, fifth or sixth nucleic acid sequence is operably linked to a heterologous or gene edited promoter, and wherein the banana plant exhibits increased resistance to Fusarium oxysporumf sp. cubense Tropical Race 4 (TR4) compared to a banana plant lacking the nucleic acid construct.
Inherently, the scope of these sequences is found in a construct, thus are not present, at least in their native form, in the plant genome. However, in view of the specification, this does not appear to be the situation.
In the case of element, a). Genbank accession No XM_065186548 disclose that SEQ ID NO 1. Comprises a known BAG family of molecular chaperone regulatory 1-lile mRNA. A comparison of SEQ ID #1 is shown below. This sequence is 99% identical to the BAG sequence disclosed in the instant application.
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Furthermore. a written description requires that the specification clearly convey to a person of skill in the art that the inventor had possession of the claimed invention at the time of filing. This requires the identification of each claimed element in the specification (with sufficient detail) and structural or functional description showing how the elements operate together. There is limited support for any combinations of elements covered by the multiple arrangements within the scope of the claim. In this instance case, claim 1, for example, requires that the 10 distinct elements are considered in a “combination thereof” composition. Thus, the claim allows any subset of elements a through j, but the specification does not have examples of every possible combination.
The claims also requires edits to DMR6, ATG8f and RGA2, but there is no support for the multitude of edits encompassed by these limitations. The claims also requires that increased resistance to TR4 for some combinations but the claim clearly covers untested combinations due to the absence of an explanation of the mechanism of resistance engendered by the “edited” plant.
Under Ariad v. Eli Lilly 598 F.3d 1336 (Fed. Cir. 2010) (en banc): a claim is adequately supported by the specification as to the individual sequence elements explicitly identified by SEQ ID numbers and the specific gene edits that are given sequence identifiers. However, the extreme breadth created by the open-ended phrase “or k) combinations thereof” and for any coverage that would read on untested permutations or on edits to loci beyond the specific edited sequences disclosed. Under Ariad a disclosure of representative species or structural features for a claimed genus and clear possession of the invention; the specification supports many but not necessarily all permutations encompassed by the claim. Similarly, in Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993): which pertains to claims for nucleotide sequences, the disclosure must include either the nucleotide sequence or sufficient structural detail (e.g., representative molecules, conserved structural features) to show possession; simply describing a method or predicting a sequence is not enough.
Furthermore, the use of functional language, (“wherein the banana plant exhibits increased resistance to TR4”) requires representative working examples. In this instance the claim covers combinations or permutations that were not shown to produce the functional result and no structural reason is provided to predict success across the entire claimed range, possession of the entire claimed functional genus may be lacking.
The requirement for written description requires that the inventor had possession of the claimed invention at the time of filing. In this case the specification fails to meet the requirements 35 USC 112(a) as providing an adequate written description of the invention.
Double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 15, 17-19, 21-22 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, 11-13 and 16-24 of copending application no. 18/470048. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of each are drawn to a transgenic or edited banana plant that exhibits increased resistance to Fusarium oxysporum f.sp. Tropical Race 4 (TR4) (claim 1(k)) compared to a banana plant lacking the claimed nucleic acid construct and Bcl-2 associated athanogene (BAG) family of molecular chaperone regulator protein (claim 1(a)). Additionally, instant 1(b) encodes a first antimicrobial peptide while in ‘048 recited inhibits cytochrome P450. Cytochrome P450 mediates response to biotic /abiotic stress of which stress is similarly mediated. Both applications recited the inclusion of betalain biosynthesis. Furthermore, both the instant application and the copending application comprise a series of heterologous promoters and terminator sequences that overlap in scope and because the instant claims recite an open combination of these elements, the instant application and the copending applications are obvious variants of each other in the absence of specific construct that distinguish one from the other.
Prior Art
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)(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, 4, 5, 7, 10, 12-13, 14, 15, 17, 19, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Dale et al.
Dale et al. (US2021/00400858) disclose a transgenic banana plant produced by the transformation of the parent banana Cavendish Grand Nain via T-DNA insertion and selection. The plant named QCAV-4 comprises a resistance gene under control of the NOS promoter isolated from Musa acuminata subsp. malacensis which is resistant to Fusarium wilt Tropical race 4 (TR4). Regarding claims 1 and 4, Dale et al. teaches the plant is a Musa accuminata banana plant. Regarding claim 5, Dale et al. teaches that the plant is under expression control of the heterologous NOS promoter that is derived from Agrobacterium tumefaciens Ti plasmid. Regarding claim 7, Dale teaches that the plant comprises a selectable marker. Regarding claims 12 and 13, the transgenic banana plant comprises two or more of the nucleic acid sequences in that it expressed the TR4 resistance gene and a selectable marker. Regarding claim 14, Dale et al. teaches the nucleic acid sequences operably linked to a heterologous promoters. Regarding claim 15, 17, 19, and 21 Dale et al. teach plant parts of the plant of claim 1 (Tables 1-3). Regarding claim, 18, Dale et al. teach the banana comprises detectable amounts of the inserted nucleic sequence [0029]. Accordingly, Dale et al. teach a method of producing a banana plant. And the plant perse with increased resistance to Fusarium oxysporumfsp. cubense Tropical Race 4 (TR4) comprising introducing a nucleic acid construct into a banana plant comprising a combination of the elements recited.
The prior art anticipates the claimed invention
Conclusion
No claim is allowed.
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/GARY BENZION/ Ph.D. Supervisory Patent Examiner, Art Unit 1681
1 For simplicity the nonce XXX is used as a place holder