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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 5/11/20265 is acknowledged. The traversal is on the ground that “the elected Group I is used in the non-elected method of Group II and Group III” (response, p.1, para 2, line1-2).
This is not found persuasive because the application is a 371 PCT. The groups share a technical feature, but that feature does not qualify as a special technical feature as it does not make a contribution over the prior arts cited. The groups also lack the same or corresponding special technical feature, as explained in the Office action dated 04/06/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-2, 4, 6-8, 10-11, 13-14, 16 and 18-26 are pending.
Claims 13-14, 16 and 18-26 are not being examined as part of non-elected groups.
Claims 1-2, 4, 6-8 and 10-11 are being examined.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 is drawn to the expression cassette of claim 1 further comprising an ER-signal sequence operatively linked to the 5' end of the gene for an aflatoxin-degrading enzyme; wherein the ER-signal sequence is from an Arabidopsis chitinase gene.
The expression cassette as recited in the claim is a nucleotide sequence while the ER-signal sequence is an amino acid sequence. The claim also indicates that the ER-signal sequence is operatively linked to the 5’ end of the “gene” for an aflatoxin-degrading enzyme. It is understood that a nucleotide sequence encoding an ER-signal sequence would be operatively linked to the coding sequence of aflatoxin-degrading enzyme. But as written in claim 2, the 5’ end of a gene would imply 5’ end of its upstream regulatory sequence or, mostly, the promoter sequence. Operatively linking the polynucleotide sequence encoding the ER signal to the upstream regulatory/promoter sequence would not result in producing a fusion protein with the ER signal and the aflatoxin-degrading enzyme.
It is suggested to amend the claim accordingly in the line as indicated in the specification (p.4, para 0017, for example).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 10 is 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 10 depends from claim 1, and is drawn to the plant-specific promoter comprises an endosperm promoter or a glycinin promoter. Claim 1 recites, “… aflatoxin-degrading enzyme and a selectable marker, both operatively linked to a plant-specific promoter”. It is unclear whether in claim 10, both promoters, or only one, is limited to comprising an endosperm promoter or glycinin promoter. And if it is only one of them, it is unclear which one. This is further unclear, given that the specification, in the EXAMPLE, the selectable marker gene is not expressed by an endosperm or glycinin promoter but a constitutively expressed promoter (spec, p. 13, para 0056, last 2 lines).
To provide better customer service and compact prosecution, the Examiner interprets claim 10 as any one of the plant-specific promoters can be an endosperm or glycinin promoter.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4, 6-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Herman et al. (US20190024104 A1, published on 24 January 2019) in view of Xu et al. (Crystal structures of Aflatoxin-oxidase from Armillariella tabescens reveal a dual activity enzyme, 2017, Biochemical and Biophysical Research Communications, 494:621e625).
Claim 1 is drawn to an expression cassette comprising a gene for an aflatoxin-degrading enzyme and a selectable marker, both operatively linked to a plant-specific promoter.
Herman et al. describes a plant expression cassette comprising polynucleotide sequence encoding a heterologous protein (human epidermal growth factor protein, hEGF), an ER signal sequence from Arabidopsis chitinase gene (as recited in claim 2), the ER-directed EGF open reading frame (ORF) is operably linked to a plant specific glycinin regulatory element (reads on to glycinin promoter, as recited in claim 10) and a hygromycin resistance gene under a strong constitutive promoter selectable marker (p.4, para 0033, line 1-13). The ER signal sequence in the expression cassette targets the heterologous protein (fused to the ER signal sequence) to ER (p.2, para 0020) (as recited in claim 6) while the ER retention signal help storing the heterologous target protein in ER (as recited in claim 7). The ER signal peptide and/or the retention signal/tag enhance(s) the yield of the target protein (p.1, para 0012, last 3 lines). The ER signal sequence can be added to the N-terminal end of the target protein (reads on to 5’ end of the gene encoding the target protein), as described by Herman et al. (p.1, para 0006, line 7-10), as recited by claim 2. Herman et al. also describes an ER-retention signal (KHDEL, SEQ ID NO: 3) operatively linked to the 3' end of the target gene (hEGF) (Fig. 8B; p.2, para 0021; Fig 8C, para 0022), as recited in claim 4. Expression of the target gene regulated by the soybean seed storage protein (glycinin) promoter resulted in the accumulation of the heterologous target protein at a high level (> 100 µg/gm of dry soybean seed) (p.1, para 0006, line 10-12).
However, Herman et al. does not describe any aflatoxin-degrading enzyme.
Xu et al. describes a novel aflatoxin degradation enzyme (GenBank accession No.
AY941095.1, published on 19 September 2017) was isolated and purified from Armillariella tabescens (as recited in claim 8) which is able to completely degrade aflatoxin B1, AFB1 (abstract; p.1, left column, para 1, line 5-9).
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to modify the plant expression cassette, as described by Herman et al., by replacing the polynucleotide sequence encoding the hEGF with a polynucleotide sequence encoding the aflatoxin degradation enzyme, as described by Xu et al. The ordinarily skilled artisan can alternatively also modify Herman by including the aflatoxin-degrading enzyme encoding polynucleotide sequence in the expression cassette, operably linked to the glycinin promoter as well for seed-specific expression, and operatively-linked to the ER signal and retention sequences, to enhance the yield of this enzyme, as well, while expressing the hEGF protein.
Before the effective filing date, the artisan would have been motivated to express the aflatoxin degradation enzyme in the seeds of the transgenic soybean plants with a realistic expectation to degrade aflatoxin B1, AFB1, which is the most common mycotoxins in food and feed, and, thus, enhancing commercial value of the feed/food containing soybean seeds or products thereof. Producing both the commercially important proteins (hEGF and aflatoxin degradation enzyme) together (trait stacking) would also be beneficial.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Herman et al. in view of Xu et al. as applied to claims 1-2, 4, 6-8 and 10 above, and further in view of Nakamura et al. (Gateway Binary Vectors with the Bialaphos Resistance Gene, bar, as a Selection Marker for Plant Transformation, 2010, Biosci. Biotechnol. Biochem., 74:1315–1319).
Claim 11 depends from claim 1 and is drawn to an expression cassette comprising the bialaphos resistance (bar) gene as the selectable marker gene.
Herman et al. in view of Xu et al. describes an expression cassette comprising a gene for an aflatoxin-degrading enzyme and the hygromycin selectable marker gene, as discussed above.
However, Herman et al. in view of Xu et al. does not describe a bialaphos resistance (bar) gene.
Nakamura et al. describes plant expression vectors (cassettes) comprising the bialaphos resistance gene (bar) as a selection marker for plant transformation. Bialaphos and its degraded derivative glufosinate (also known as phosphinothricin) are active ingredients of many widely used herbicides that inhibit glutamine synthetase in plants (p.1, left column, para 1, line 1-5). Another advantage of such herbicides having in selection of transformants is the absence of any necessity of sterile agar media, which is required for selection with kanamycin or hygromycin B (which are also more expansive), because splaying herbicides easily kills soil-grown plants that do not have the corresponding resistance gene (p.1, right column, para 1, last 6 lines).
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to modify the expression cassette, as described by Herman et al. in view of Xu et al., and replace the hygromycin resistance gene with the bialaphos resistance (bar) gene as the selection marker, as described by Nakamura et al., in the plant expression cassette.
Before the effective filing date, the ordinarily skilled artisan would have been motivated to replace the hygromycin resistance gene with the bialaphos resistance (bar) gene as the selection marker in the plant expression cassette to avoid more expansive and time-consuming selection of the target transgenic plants using sterile agar enable and use less expansive and widely used herbicides like bialaphos and glufosinate/phosphinothricin.
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 1-2, 4, 6-8 and 10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,889,826 B2 (published on 12 January 2021) in view of Xu et al.
Reference claim 1 is drawn to a transgenic soybean (plant) expressing a polynucleotide sequence encoding a endoplasmic reticulum (ER)-directed human epidermal growth factor (hEGF) protein by transforming the soybean plant with an artificial DNA construct (reads on to “expression cassette”) comprising a soybean (plant) specific promoter (as recited in instant claim 1), a polynucleotide sequence encoding an ER signal peptide comprising SEQ ID NO: 24 operably linked to the 3' end of the promoter, a polynucleotide sequence encoding hEGF protein operably linked to the 3' end of the sequence encoding the ER-signal peptide ((which reads on to “ER-signal sequence operatively linked to the 5' end of the (target heterologous) gene”, as recited in instant claim 2)), a nucleotide sequence encoding an ER retention signal comprising SEQ ID NO: 25 (KHDEL) ((which reads on to “an ER-retention signal operatively linked to the 3' end of the gene” (encoding the target protein)…. wherein the ER-retention signal comprises the sequence SEQ ID NO: 3” (KHDEL), as recited in instant claim 4)).
Reference claim 1 recites the ER signal sequence peptide comprises reference SEQ ID NO: 24, which is 100% identical (as shown below) to the ER-signal sequence from an Arabidopsis chitinase gene (as recited in claim 2), as described by the Applicant (Spec, p.9, Table 2, underlined sequence in the 5’ part of SEQ ID NO: 2).
Title: AASEQ1_05272026_115001
Perfect score: 180
Sequence: 1 MKTNLFLFLIFSLLLSLSSAEFKTNLFLFLIFSLLLSLS 39
Searched: 1 seqs, 722 residues
Database : US-18-553-953-2.fasta:*
RESULT 1
US-18-553-953-2
Best Local Similarity 100.0%; Query Match 56.7%; Score 102; DB 1; Length 722;
Matches 22; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKTNLFLFLIFSLLLSLSSAEF 22
||||||||||||||||||||||
Db 1 MKTNLFLFLIFSLLLSLSSAEF 22
However, the reference claim 1 or any other reference claim does not recite a gene for an aflatoxin-degrading enzyme.
Xu et al. describes a novel aflatoxin degradation enzyme (GenBank accession No.
AY941095.1, published on 19 September 2017) was isolated and purified from Armillariella tabescens which is able to completely degrade aflatoxin B1, AFB1 (abstract; p.1, left column, para 1, line 5-9), as recited in instant claim 8.
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to modify the plant expression cassette, as described by reference claim 1, by replacing the polynucleotide sequence encoding the hEGF with a polynucleotide sequence encoding the aflatoxin degradation enzyme, as described by Xu et al. The ordinarily skilled artisan can alternatively also modify Herman by including the aflatoxin-degrading enzyme encoding polynucleotide sequence in the expression cassette, operably linked to the glycinin promoter as well for seed-specific expression, and operatively-linked to the ER signal and retention sequences, to enhance the yield of this enzyme, as well, while expressing the hEGF protein.
Before the effective filing date, the artisan would have been motivated to express the aflatoxin degradation enzyme in the seeds of the transgenic soybean plants with a realistic expectation to degrade aflatoxin B1, AFB1, which is the most common mycotoxins in food and feed, and, thus, enhancing commercial value of the feed/food containing soybean seeds or products thereof. Producing both the commercially important proteins (hEGF and aflatoxin degradation enzyme) together (trait stacking) would also be beneficial.
Regarding instant claim 6, presence the ER-signal sequence fused to any heterologous protein including an aflatoxin-degrading enzyme would target the fusion protein to the ER, as taught by the instant description (spec, p. 10, para 0041).
Regarding instant claim 7, presence the ER-retention signal fused to any heterologous protein including an aflatoxin-degrading enzyme would target the fusion protein to the ER, as described by the Applicant (spec, p. 10, para 0042).
Regarding instant claim 10, reference claims 2-3 recite a seed-specific promoter (reads on to endosperm specific) and a glycinin promoter, respectively.
Instant claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 010889826B2 in view of Xu et al. as applied to instant claims 1-2, 4, 6-8 and 10 above, and further in view of Nakamura et al.
Claim 11 depends from claim 1 and is drawn to an expression cassette comprising the bialaphos resistance (bar) gene as the selectable marker gene.
Reference claims 1-3 in view of Xu et al. describe an expression cassette comprising a gene for an aflatoxin-degrading enzyme and a selectable marker gene operatively linked to a plant-specific promoter, as discussed above.
However, Reference claims 1-3 in view of Xu et al. do not describe a bialaphos resistance (bar) gene.
Nakamura et al. describes plant expression vectors (cassettes) comprising the bialaphos resistance gene (bar) as a selection marker for plant transformation. Bialaphos and its degraded derivative glufosinate (also known as phosphinothricin) are active ingredients of many widely used herbicides that inhibit glutamine synthetase in plants (p.1, left column, para 1, line 1-5). Another advantage of such herbicides having in selection of transformants is the absence of any necessity of sterile agar media, which is required for selection with kanamycin or hygromycin B (which are also more expansive), because splaying herbicides easily kills soil-grown plants that do not have the corresponding resistance gene (p.1, right column, para 1, last 6 lines).
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to modify the expression cassette (as described by reference claim 1 in view of Xu et al.) and replace the hygromycin resistance gene with the bialaphos resistance (bar) gene as the selection marker, as described by Nakamura et al., in the plant expression cassette.
Before the effective filing date, the artisan would have been motivated to replace the hygromycin resistance gene with the bialaphos resistance (bar) gene as the selection marker in the plant expression cassette to avoid more expansive and time-consuming selection of the target transgenic plants using sterile agar enable and use less expansive and widely used herbicide(s) like bialaphos and glufosinate/phosphinothricin.
Conclusion
No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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JC
/Jay Chatterjee/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662
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