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 .
Claims 21-40 are pending and examined on their merit herein.
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 21-29 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 claims are drawn to plants comprising a genomic window or methods of using plants comprising a genomic window wherein the genomic window is measured in units of centimorgans (centiMorgans, cM). A centimorgan is frequently mistaken to be a measure of genomic distance; however, it is actually a measure of the probability that a crossover (meiotic recombination) event will occur between the two positions on a chromosome in a single generation. This cannot be considered a discrete distance, because recombination rates vary among plant species and even within the same species via either environmental growth conditions of the plants. Further, there are also hyperrecombinogenic mutant plants that have much higher recombination frequencies than their wild-type counterparts. Thus, it in breeding schemes it becomes unclear if a given plant would meet the limitations of the claims. For example, a hyperrecombinogenic plant may comprise a genomic window that is 10 cM and said genomic window is crossed into an elite variety plant that has a wild-type recombination rate. Further, a plant may comprise a genomic window that is 0.1 cM under one environment, but the window is actually less than 0.1 cM in another environment. For example, Wijnker and Jong, 2008, Managing meiotic recombination in plant breeding, Trends in Plant Science 13: 640-646 discuss how recombination rates are subject to environmental conditions including growth temperature, light radiation, and the presence of chemical agents (page 641, right-hand col., second full paragraph). Wijnker and Jong also discuss genetic regulation of crossover frequency, and the fact that certain mutants or overexpressers have increased recombination rates, and that the recombination rate of barley cultivars can vary by 30% (page 641, left-hand col., first paragraph). Given these facts, the metes and bounds of claims 21-40 cannot be determined.
Furthermore, the Specification has not provided a genomic position for the SNP markers represented by SEQ ID Nos. Some of the SNP markers are not found in all tobacco varieties. For example, SEQ ID NO: 59 is not found in K326 genome. Thus, it is unclear what the “one or more molecular markers located within 20 cM of a SNP marker …… of SEQ ID NOs: 59” would be if SEQ ID NO: 59 is not present in a given genome. On the other hand, such “one or more molecular markers” that is found within 20 CM of SEQ ID NO: 59 in, say, the genome of TN90 tobacco, may also be present in K326. However, it is not clear if such a marker is included in the instant claims since it is not associated with SEQ ID NO: 59 in K326—or a derived progeny plant.
Claims 25 and 26 recite the limitation "the second tobacco" in line 1. Claims 25 and 26 are dependent on claim 21, which does not recite a “second tobacco”. There is insufficient antecedent basis for this limitation in the claim.
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 21-29 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.
The Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not description of that material". Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus". Id.
The claims broadly require a broad genus of molecular markers located within 5 cM of an enhanced NUE locus comprising a polynucleotide sequence at least 95% identical to a sequence selected from the group consisting of SEQ ID NOs: 9, 10, 11, 12, 13, 14, 15; or molecular marker sequences at least 99% identical to a sequence selected from the group consisting of SEQ ID NOs: 57, 58, 59, 60, 61, 62, 63, and 64, to have the function of conveying to a tobacco plant an enhanced NUE trait.
The Specification has described SEQ ID NOs: 9 to 16 as nucleotide sequences of genes positively correlated with enhanced NUE in root tissue, leaf tissue, or both.
The Specification has described the identification of a set of SNP markers, represented by favorable alleles and the SEQ ID Nos, e.g, SEQ ID NO: 57, that are associated with different genes that are positively or negatively correlated with enhanced NUE in tobacco (pages 108-109, Tables 6-10). For example, SNP marker SEQ ID NO: 57 has been described as being associated with: Genes identified as negatively correlated with NUE: SEQ ID NO: 25, Putative vacuolar proton ATPase subunit E; SEQ ID NO: 28, ATPase family AAA domain-containing protein 1-a-like; SEQ ID NO: 29, “Uncharacterized protein”; SEQ ID NO: 40, Uncharacterized protein; SEQ ID NO: 34, ABC transporter F-family member 3-like; SEQ ID NO: 35, Uncharacterized protein;
However, The Specification has also described that SNP marker SEQ ID NO: 57 is associated with genes that are positively correlated with NUE: SEQ ID NO: 1, PR-10 type pathogenesis-related protein; SEQ ID NO: 5, Glucose-6-phosphate 1-epimerase-like; and SEQ ID NO: 8, 3-isopropylmalate dehydratase small subunit.
The Specification has not described the genetic distance between the SNP markers, e.g., SEQ ID NO: 57, with the NUE genes (positive or negative).
It should also be cautioned that the Specification has not described the degree of the positivity of the correlation. It has not been described how much each of the individual SNP marker allele would contribute to any of the NUE trait. Most importantly, it has not been adequately described whether a single SNP marker would be sufficient to cause any meaningful enhancement of any NUE trait, or whether the entire ensemble of the SNP markers represented by from SEQ ID NOs: 57, 58, 60, 61, 62, 63, and 64, must be present in order to result in enhanced NUE trait (e.g., in the breeding progeny).
It is noted that SEQ ID NO: 57 is mapped to Nicotiana tabacum Chromosome 15, position 3733165 to 3732851; while SEQ ID NO: 16 (encoding SEQ ID NO: 8) is mapped to Chromosome 11 51255543 to 51256303; SEQ ID NO: 9 (encoding SEQ ID NO: 1) mapped to Chromosome 16 (Nicotiana tabacum var. NtaSR1 v1.0; Phytozome genome ID: 945; see Wang, J., Zhang, Q., Tung, J., Zhang, X., Liu, D., Deng, Y., … Li, F. (2024). High-quality assembled and annotated genomes of Nicotiana tabacum and Nicotiana benthamiana reveal chromosome evolution and changes in defense arsenals. Molecular Plant, 17(3), 423–437.) It is not clear how the SNP marker SEQ ID NO: 57—or any of the broadly recited molecular markers—are within “5 cM” of the “NUE” genes represented by SEQ ID NO: 9-16 given the NUE genes are located on different chromosomes, i.e., in different linkage groups.
The Specification has not specifically described nor reduced to practice a representative number of molecular markers and of marker alleles (as SNPs) that are located in the claimed interval of ± 5 cM relative to SEQ ID NOs: 9-16, in the claimed method to producing a tobacco plant comprising an enhanced NUE trait. As pointed out above, the markers described as being linked to some of the NUE genes of SEQ ID Nos 9-16 are NOT in fact linked. The Specification has not described the necessary markers associated with the claimed phenotype, nor the necessary (i.e., favorable) allele(s) associated with the particular SNP markers, such that, the Specification has not disclosed a conserved structure responsible with respect to the markers and alleles as to accomplish the instantly claimed function of enhanced NUE trait phenotype in tobacco.
The claims are not limited to specific molecular markers and specific alleles with the SNP indicative of the claimed phenotype of enhanced NUE traits in tobacco.
Furthermore, The Specification has not provided sufficient guidance for the number, identity, and physicochemical characteristics of the broadly claimed genus of unspecified molecular markers that are present in the broadly claimed region within 5 cM of genes having 95% identity to any of SEQ ID NOs: 9-16.
Given Applicants have provided very vague description of the method steps or structures that would link a myriad of unspecified molecular markers that are located in the region within 5 cM of genes having 95% identity to any of SEQ ID NOs: 9-16, and which are determinants of enhanced NUE traits in tobacco, it remains unclear what features or method steps are capable of performing the claimed function. The Specification fails to provide an adequate written description to support the breadth of the claims. Therefore, one skilled in the art would not have recognized Applicants to be in possession of the claimed invention at the time the application was filed.
Scope of Enablement
Claims 20-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for modified tobacco comprising a cisgenic polynucleotide comprising a heterologous CsVMV promoter operably linked to a coding region encoding the polypeptide set forth in SEQ ID NOs:1-8, does not reasonably provide enablement for the modified tobacco plant grown therefrom, comprising a cisgenic polynucleotide comprising a heterologous promoter having 95% identity to SEQ ID NOs:17-24 operably linked to a coding region encoding a polypeptide comprising at least 95% sequence identity to a sequence selected from the group consisting of SEQ ID NOs:1-8,. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
The claims broadly require a broad genus of a coding region encoding a polypeptide comprising at least 95% sequence identity to any of SEQ ID NOs:1-8, operably linked to any heterologous promoter, or promoter 95% identical to SEQ ID NO: 17-24, have the function of conveying to a tobacco plant an enhanced NUE trait.
The Specification has taught the identification of number of genes that are positively correlated with enhanced NUE in tobacco, e.g., with amino acid sequences set forth in SEQ ID NO: 1-8, encoded by nucleotide sequences SEQ ID NO: 9-16 (pages 108-109, Tables 8-9; for example). The Specification has taught transgenic tobacco plants expressing the genes encoding SEQ ID Nos: 1-8 under the control of a CsVMV promoter, whereby achieving enhanced nitrogen use efficiency in only “one of the lines overexpressing G41446” (SEQ ID NO: 8) (Example 5). The Specification has stated that transformation vectors comprising one of SEQ ID NOs:9 to 16 are incorporated into p45-2-7 transformation vectors (Example 6), and the “modified tobacco plants exhibit enhanced nitrogen utilization efficiency”.
The Specification has not taught any genes that encoding proteins having 95% sequence identity to any of SEQ ID NOs:1-8 that are “positively correlated with enhanced nitrogen utilization efficiency”. The Specification has not taught any transgenic tobacco plants expressing such genes that encoding proteins having 95% sequence identity to any of SEQ ID NOs:1-8 that have enhanced NUE. In fact, the Specification has not taught, convincingly, that each of SEQ ID NOs:1-8, under any heterologous promoter, would have conferred enhanced NUE to a modified tobacco plant. As discussed above, the Specification has only taught constructs in the p45-2-7 transformation vector which contains the CsVMV promoter, with mixed and inconsistent results.
The Specification has not taught the modified plants having any of SEQ ID NOs:1-8, or 95% identical variants thereof, under the control of any of the promoters having 95% identity to SEQ ID NO: 17-24, or SEQ ID NO: 17-24, to have enhanced NUE.
As shown in the Specification, the “positive correlation” has not been reasonably predictive for enhanced NUE when the genes are heterologously expressed. It would have been further unpredictable for any of the promoters having 95% identity to SEQ ID NO: 17-24, or SEQ ID NO: 17-24, to have enhanced NUE.
In the absence of guidance from either the instant disclosure or the art, it would require trial and error experimentation for a skilled artisan to practice the invention within the full scope of these Claims.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
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 21-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. US12284977B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are drawn to a method of producing a tobacco plant comprising an enhanced NUE trait, the method comprising providing a first population of tobacco plants comprising an enhanced NUE trait; genotyping the first population of tobacco plants for the presence of one or more molecular markers located within 5 cM of an enhanced NUE locus comprising a polynucleotide sequence at least 95% identical to a sequence selected from the group consisting of SEQ ID NOs: 9-16, selecting a tobacco plant comprising the one or more molecular markers; crossing the tobacco plant with a second tobacco plant; and obtaining at least one progeny plant with the enhanced NUE locus and the enhanced NUE trait.
The patented claims are drawn to a method of producing a Nicotiana tabacum plant comprising an enhanced NUE trait, said method comprising:
a) selecting a Nicotiana tabacum plant comprising at least one favorable NUE allele comprising a T nucleotide at a position corresponding to position 36 of SEQ ID NO: 61 or a T nucleotide at a position corresponding to position 36 of SEQ ID NO: 64;
b) crossing said Nicotiana tabacum plant selected in step a) with a second Nicotiana tabacum plant; and
c) obtaining progeny seed from a cross of step b) wherein a plant grown from said progeny seed comprises said enhanced NUE trait and said at least one favorable NUE allele.
As disclosed, the SNP marker SEQ ID NO: 64 is linked to one of the enhanced NUE loci set forth in SEQ ID NOs: 9-16.
Therefore, although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 21-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US11602118B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patented claims are drawn to a method of producing a tobacco plant comprising an enhanced nitrogen utilization efficiency (NUE) trait, said method comprising:
a. providing a first population of tobacco plants comprising at least one tobacco plant comprising an enhanced NUE trait;
b. obtaining nucleic acids from said first population of tobacco plants;
c. genotyping said nucleic acids from said first population of tobacco plants via a molecular assay for the presence of one or more molecular markers located within 10 cM of a SNP marker comprising SEQ ID NO: 58;
d. selecting a tobacco plant comprising said one or more molecular markers and a favorable NUE allele at SEQ ID NO: 58;
e. crossing said tobacco plant selected in step (d) with a second tobacco plant; and
f. obtaining progeny seed from the cross of step (e) wherein a plant grown from said progeny seed comprises an enhanced NUE trait and said SNP marker.
As disclosed, the SNP marker SEQ ID NO: 58 is linked to one of the enhanced NUE loci set forth in SEQ ID NOs: 9-16.
Therefore, although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 21-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US10888064B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patented claims are drawn to a method of producing a tobacco plant comprising an enhanced nitrogen utilization efficiency (NUE) trait comprising:
a. providing a first population of tobacco plants comprising an enhanced NUE trait;
b. genotyping said first population of tobacco plants via a molecular assay for the presence of one or more molecular markers located within 10 cM of a SNP marker comprising the sequence of SEQ ID NO:57 and having a polymorphic position 147 with an allele of T associated with an enhanced NUE trait;
c. selecting a tobacco plant comprising said one or more molecular markers;
d. crossing said tobacco plant selected in step (c) with a second tobacco plant; and
e. obtaining progeny seed from the cross of step (d) wherein a plant grown from said progeny seed comprises said enhanced NUE trait and said one or more molecular markers.
As disclosed, the SNP marker SEQ ID NO: 57 is linked to one of the enhanced NUE loci set forth in SEQ ID NOs: 9-16.
Therefore, although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
No claims are allowed.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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