DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statements
The Information Disclosure Statements filed on 2/21/2024 have been entered and considered. Initial copies of the form PTO-1449 are enclosed with this action.
Priority
Instant application filed 11/1/2023, does not have priority application(s).
Objection to the Specification
The specification is objected because:
In [0220], lines 4-5, the “NCMA Deposit Nos. XXXX and YYYY”, should be two real deposit numbers. In line 5, the “on [date]” appears twice, and should be 2 real dates.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending application 17932502/USPGPUB 20240090409 (filed 9/15/2022 by Pioneer Hi Bred).
The rejection is provisional, because although 17932502 was allowed on 7/1/2025, the patent has not been issued.
The co-pending and instant applications share multiple inventors and the same applicant of Pioneer Hi Bred.
Co-pending application claims (as amended on 11/26/2024):
Claim 1. A seed of hybrid canola variety 21GG1082N, representative seed produced by crossing a first plant of variety 4PYYM82A with a second plant of variety 3NR057, wherein representative seed of the varieties 4PYYM82A and 3NR057 have been deposited under NCMA Accession Numbers 202207062 and 202007012, respectively.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The co-pending and instant applications claim the exact same product, seed of hybrid canola variety 21GG1082N, produced by crossing the same parents 4PYYM82A and 3NR057. Claim 1 of the co-pending application recites specific NCMA accession numbers, thus, is more specific than instant claim 1.
All of the dependent claims of co-pending and instant applications claim the same subject matter and have essentially the same claim languages, except that the amended co-pending claims are more specific—reciting specific characteristics (amended claim 5).
Therefore, the claims are obvious over each other.
There is no apparent reason why applicant would be prevented from presenting claims corresponding to those of the instant application in the co-pending application (filed 9/15/2022, earlier than instant application). See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
In addition, the co-pending application 17932502 is not disclosed in the IDS of 2/21/2024.
Note: double patenting rejection under USC 101 is not made because (1) the claim languages are not identical, and (2) the co-pending claims are more specific than instant application claims: specific NCMA accession numbers, and specific characteristics (see amended claim 5).
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claims 1-20 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 pre-AIA the applicant regards as the invention.
According to MPEP 2173, where possible, claims are to be complete in themselves.
In this case, claims (1, 5, 12) recite “XXXX” and “YYYY” after NCMA accession numbers, thus, are not complete.
Therefore, 21GG1082N is not an art recognized or accepted term.
Dependent claims do not cure the deficiency.
Appropriate corrections and clarifications are required.
It is required to amend the claims and the specification to include real deposit numbers.
Note: as analyzed above, in co-pending 17932502/USPGPUB 20240090409, filed 9/15/2022 by Pioneer Hi Bred, varieties 4PYYM82A and 3NR057 have been deposited under NCMA Accession Numbers 202207062 and 202007012, respectively. Accordingly, the enablement rejection for lacking deposits is not made.
Lacking written description
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.
Claims 4-11 are rejected under 35 U.S.C. 112(a), 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.
To claim a genus under the written description requirement, the applicant is required to describe a representative number of species to reflect the variation within the genus or structures sufficient to define the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combinations thereof.
By court' s statement in Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), a written description of an invention “requires a precise definition, such as a structure, formula, or chemical name, of the claimed subject matter sufficient to distinguish it from other materials”; further, a written description of a claimed genus requires a description of a representative number of species of the claimed genus, and one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”.
According to the specification ([0219]), "a" or "an" should be read to include one or at least one, and the singular word form of the element or component also includes the plural unless the number is obviously meant to be singular.
According to the specification ([0049]), “Examples of single locus conversions include mutant genes, genome edits, transgenes (all in plural form) and native traits finely mapped to a single locus. One or more locus conversion traits may be introduced into a single canola variety.
Thus, claim 4 is broadly drawn to a genus of seeds of claim 1 (21GG1082N) further comprising a genus of transgenes.
Claim 5 is broadly drawn to a genus of seeds of 21GG1082N further comprising a single locus conversion but nevertheless comprising a genus of transgenes and other genetic modifications.
The specification describes species 21GG1082N in structure/genetic background--a single cross canola variety and made by crossing inbreds 4PYYM82A and 3NR057, and representative morphological characteristics and traits (Example 1 in [0221]-[0222], Table 1). The species 21GG1082N does not further comprises any transgene or any locus conversion.
However, critically,
(1) the claims do not require do not require otherwise comprising all the physiological and morphological characteristics of canola variety 21GG1082N; and
(2) the specification does not describe a single species, not to mention the common structure feature of 21GG1082N further comprising any transgene or any locus conversion.
In the art, genetical modifications can cause unintended changes in canola (Brassica napus). For example, Amosova et al (Phenotypic, biochemical and genomic variability in generations of the rapeseed (Brassica napus L.) mutant lines obtained via chemical mutagenesis. PLOS ONE. P1-20, 2019) teach and demonstrated that mutations can result in cytogenetic instability in the mutant progeny in Canola (p1, Abstract; p15, 2nd para; p16, 1st para).
In addition, Chen et al (A high-quality Brassica napus genome reveals expansion of transposable elements, subgenome evolution and disease resistance. Plant Biotechnology Journal, 19, p615–630, 2021) teach that canola (Brassica napus, or Rapeseed) is a recent allotetraploid crop (p615, Abstract), thus, comprises different sets of sub-genomes from the interspecific hybridization between related species (p615, left col, 1st para). Thus, canola has more complex genomes and chromosomes (p621, fig 4, p623, fig 5).
Hence, the genus of seeds and plants of 21GG1082N that further comprises a genus of transgenes and/or genetic modifications like mutations, and so on likely would have significant random genotype changes that lead to changes in physiological and morphological characteristics, thus, would not likely retain the original genotype, and physiological and morphological characteristics of the species 21GG1082N.
Regarding the aspect of representative number of species, 21GG1082N (a species originated from original parents) does not comprise any transgenes, locus conversion or genetic modifications. The genus of seeds, plants, plant parts, or plant cells, of variety 21GG1082N that also comprises a genus of transgenes, locus conversion including genetic modifications (transgenes, edits and mutations), and the progenies, converted seeds, plants, plant parts, transgenic seeds, plants, plant parts comprising further genetic modifications, and the methods of using, encompass an extremely large number. Given that the transgenes and locus conversion are not specific but generic, the claimed genus does not have any common structure and are heterologous in structure, physiological, and morphological characteristics.
Thus, species 21GG1082N does not comprise any genetic modification, thus, does not describe the common structure feature of the genus of canola plants, and does not present (not to mention sufficiently) the genus of canola comprising genus of transgenes and locus conversion including transgenes and other genetic modifications.
Therefore, the application has not met either of the two elements of the written description requirement as set forth in the court' s decision in Eli Lilly, and has not shown her/his possession of the claimed genera.
Dependent claims 6-11 do not cure the deficiency, thus, are included.
Remarks
As analyzed above, hybrid canola variety 21GG1082N was disclosed and claimed in co-pending application 17932502/USPGPUB 20240090409, published 3/31/2024 (after instant filing date), filed 9/15/2022 by Pioneer Hi Bred. The reference is an 102(b)(2) exception. Note: the co-pending application 17932502 is not disclosed in the IDS of 2/21/2024. Otherwise, 21GG1082N has no prior art in patent, patent application or NPL. Prior art does not teach or suggest any canola having the physiological and morphological characteristics and same genetic background of the instant 21GG1082N.
According to the specification ([0117]) and claim 1, hybrid canola variety 21GG1082N is a single cross canola variety and made by crossing inbreds 4PYYM82A and 3NR057. Thus, 4PYYM82A and 3NR057 are the parents of instant 21GG1082N.
The combination of 4PYYM82A and 3NR057 has no prior art in patent, patent application or NPL, except in co-pending application 17932502 (not prior art). Thus, prior art does not disclose any sibling(s) of instant canola.
Canola 4PYYM82A, the first parent, was disclosed, deposited as NCMA 202207062, and claimed, in US Patent 12349642 (granted and published 7/8/2025, filed 9/15/2022).
Canola 3NR057, the second parent, was disclosed deposited as NCMA 202007012, and claimed, in US Patent 11252886 (granted and published 2/22/2022, filed 7/27/2020).
Conclusion
No claim is allowed.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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/Wayne Zhong/
Examiner, Art Unit 166