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 .
Applicant’s response filed 04/28/2026 in reply to the office action of 01/28/2026 has been entered. Claims 1 and 5-16 are amended. Claims 3-4, 17, 21-27, 33-36 and 47 are cancelled. New claims 48-60 are added. Therefore, claims 1, 5-16 and 48-60 are pending.
Claims 1, 5-16 and 48-60 are examined.
Withdrawn Objection and Rejections
The objection to claims 25-26 and 35-36; the 112(b) rejection to claims 17, 21-23, 25 and 33-36; the 101 and 102 rejections to claims 3-4, 6-8, 10-12, 14-15, 17, 21-22, 25-27 and 47 are withdrawn in view of the cancellation of the claims . The 112(b), the 101 and 102 rejections to the claims 1, 16, and 47 have been withdrawn in view of Applicant’s amendment to the claims. The 102 art rejection to the claims is replaced with 103 rejection in view of Applicant’s amendment to the claims.
Claim Objections
Claims 52 and 57 is objected to because of the following informalities: At claim 52, in line 3, it is suggested that “with shows” be replaced with ---which shows----.
At claim 57, it is suggested “ a plant as claimed” in part a) be replaced with ---the plant as claimed---. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1, 49-58 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Carlier et al (Plant Breeding (2012)131:170-175) in view of each of Farinho et al (Theor Appl Genet (2004) 109:1392-1398); Carlsson et al (Hereditas (2004)141:293-300); and Coelho et al (Proc. Int. Symp. On Brassicas. Acta Hort. 459 (1998)).
The claims are drawn to an agronomically elite Brassica oleracea plant that is resistant to Hyaloperonaspora brassicae, comprising a QTL on chromosome 8, 4 or 1 that can be identified with at least one marker from the markers of SEQ ID NO: 1-22 which confers resistance to Hyaloperonospora brassicae to the Brassica oleracea plant, wherein the resistance is detectable in the cotyledon stage, wherein the presence of the QTL on chromosome 8 can be identified by use of at least one of the markers of SEQ TD NOS: 1 to 7; and methods of producing said plant are also claimed.
The claims are interpreted to read on an agronomically elite downy mildew resistant Brassica oleracea plant and parts thereof that comprise unidentified QTLs on chromosome 8, 4 or 1 that confers resistance against Hyaloperonospora brassica which include the QTLs taught by Carlier et al, Farinho et al, Carlsson et al, and Coelho et al, and markers that can be identified by said markers.
Carlier et al teach a Brassica oleracea plant having resistance to downy mildew caused by Hyaloperonospora, and the presence of downy mildew resistance gene Pp523 located on chromosome 8 and shows the genetic map of the Brassica oleracea with several markers (Figs.1-2; Table 1). Carlier et al state that 68% of the markers identified were mapped to three chromosomes (C3, C4, and C5), and one on chromosome 1 (C1). Carlier et al also teach brassica seed and progeny plants including F2 seed/plants having downy mildew resistance produced from crossing of downy mildew resistant B. oleracea plants with susceptible plants (see the whole document).
Each of Farinho et al, Carlsson et al, and Coelho et al is cited in Carlier et al.
Farinho et al (2004) teach Brassica oleracea plant having resistance to downy mildew caused by Hyaloperonospora parasitica, and the presence of downy mildew resistance gene on chromosome 8 and markers closely linked to said resistance . Farihno et al disclose identification of molecular markers closely linked to said gene, said markers can be used for marker assisted selection in breeding to introduce the resistance gene into susceptible B. oleracea genotypes. Farinho et al further teach that multiple sources of genetic resistance to downy mildew are known at both the seedling and adult stage in brassica.
Carlsson et al teach a method of producing F1 progeny and further generation cabbage plants by crossing downy mildew resistant Brassica plants with susceptible plants and backcrossing selected plants to produce backcrossed progeny plants. Carlsson et al also teach that the genetic resistance that controls Hyaloperonospora parasitica in Brassica oleracea can be recessively (homozygously) inherited. Tables 1 and 4 list downy mildew resistant Brassica accessions that include old cultivars, landraces, wild type, and hybrids. Carlsson et al states “[p]revious screening of B. oleracea resistance against downy mildew at the cotyledon stage have been done with Peronospora parasitica isolates from Brassica oleracea as the original plant host plant”.
Coelho et al teach that downy resistant Brassica oleracea screened for resistance at cotyledon stage and that cotyledon resistance is easy to assay on a large number of plants and stable since it is conducted under controlled environment.
Carlier et al in view of Farinho et al, Carlsson et al, and Coelho et al do not explicitly teach SEQ ID NO: 1-22. However, the markers are inherently located in chromosomes 8, 4 and 1 and that genetic element that confers known disease resistance property in known resistant plant species, does not render the non-obvious. Claims 25-27 are included in the rejection because a harvest part that is a food product reads on parts of the cabbage plant taught by the Carlsson et al, and because the limitation “processed form” in claim parent claim 25, is optional.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instantly claimed invention to produce an agronomically elite downy mildew resistant Brassica oleracea plant and parts thereof that comprise markers linked to a QTL on chromosome 8 that confers resistance against Hyaloperonospora brassica with a reasonable expectation of success as taught by each of Farinho et al, Carlsson et al, and Coelho et al. One of skilled in the art would be able to identify other markers located on chromosome 8 linked to downy mildew resistance by using methods disclosed by Farinhno et al. Note, the rejected require the presence of the QTL on chromosome 8 can be identified by use of one of the markers of SEQ TD NOS: 1 to 7. Therefore, applicant provides no evidence that shows unexpected results related with the rejected claims.
Claim Rejections - 35 USC § 112
Claims 1, 49-58 and 60 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. This rejection is repeated for the reasons of record as set forth in the last office action. Applicant’s arguments filed 04/28/2026 have been fully considered but are not deemed persuasive.
The claims are broadly drawn to a genus of brassica plants that is resistant to Hyaloperonaspora brassicae, comprising unspecified QTLs on chromosome 8 linked to markers SEQ ID NO: 1-7 which confers resistance to Hyaloperonospora brassicae to the Brassica oleracea plant, wherein the resistance is detectable in the cotyledon stage, wherein the presence of the QTL on chromosome 8 can be identified by use of at least one of the markers of SEQ TD NOS: 1 to 7; seed, cell, a progeny or a propagation material, tissue culture, harvested part of the Brassica oleracea plant and having resistance to Hyalaperonospora brassicae. The claims are also drawn to a method of producing a Brassica oleracea plant showing resistance to Hyaloperonospora brassicae, comprising crossing a brassica plant comprising a QTL on chromosome 8 with another plant to produce an F1 population, selfing or crossing the F1 to obtain further generation population, and selecting from the further generation a plant comprising the QTL 8, wherein the selection is done using SEQ ID NO: 1-7.
In contrast, the specification describes the Brassica oleracea plant that is resistant to Hyaloperonaspora brassicae, comprising a QTL on chromosome 8, 4 and 1 linked to markers SEQ ID NO: 1-22, wherein the QTL is as comprised in the genome of Brassica plant representative seed of which was deposited under NCIMB Accession number NCIMB 43346, and wherein the QTLs are homozygously present in the plant. The specification also describes methods of using said brassica plant with the seed deposited in breeding to produce progeny having resistance to Hyaloperonaspora brassicae.
“The test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations. Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966”. While the written description requirement does not demand either examples or an actual reduction, actual “possession” or reduction to practice outside of the specification is not enough. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). Rather, it is the specification itself that must demonstrate possession. Id.
In this application, the specification does not describe a representative species of the genus of Brassica oleracea plants comprising a genus of unidentified QTL chromosome 8 that be identified by using one of SEQ ID NO: 1-7 linked to downy mildew resistance. Therefore, a substantial variation in structures and function are expected even among Brassica oleracea plants comprising any QTL on chromosome 8 which confers resistance to H. parasitica and which can be identified by use of one of SEQ ID NO: 1-7.
Further, Applicant has not demonstrated possession of the QTLs by reciting sufficient structure in combination with a recitation of function. The only structure of QTL and linked markers of SEQ ID NO: 1-7 described in the specification is the structure present in the deposited seed and plants grown from said seed. See MPEP 2163 (I) and Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) where it states “one must define a compound by "whatever characteristics sufficiently distinguish it". The specification does not describe a single QTL on chromosome 8, 4 or 1 that confers resistance to downy mildew in Brassica. Applicant provides describes Brassica oleracea comprising QTLs on chromosomes 8, 4 and 1 and linked markers of SEQ ID NO: 1-22, seed of said plant has been deposited with the NCIMB Accession no. 43346. In addition, the QTL required for the resistance to H. parasitica is not described in the specification by specific location or by sequence structure. The only information provided in the specification is the identification of molecular markers linked to the QTLs and the large chromosome 8 carrying these QTLs.
The Federal Circuit has recently clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398; 1406 (Fed. Cir. 1997). In summary, the court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. The court goes on to say, “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” (AbbVie, 759 F.3d at 1298, reiterating Enzo Biochem, Inc., 323 F.3d at 964)(emphasis added). However, in the instant application, there is insufficient evidence of such an established structure-function correlation. Therefore, the specification 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 genus at the time of the application.
Further, the specification has not described that a single marker of SEQ ID NO: 1-7 is sufficient to detect the QTL on chromosome 8 that confers resistance to downy mildew in Brassica oleracea. Therefore, since the specification fails to sufficiently describe the genus of Brassica oleracea plant/seed comprising a genus of QTLs on chromosomes 8 that can be identified by a single marker from SEQ ID NO: 1-7, which confer resistance to Hyaloperonospora brassica, cells, tissue cultures and propagation materials derived from said plant, a method that employs said plant, are similarly not described.
Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
Response to Arguments
Applicant’s arguments on page 24 of the response filed 04/28/2026 have been considered but are not deemed persuasive because of the following. 1) the recitation in the claim 1 “wherein the presence of the QTL on chromosome 8 can be identified by use of at least one marker selected from the group consisting of SEQ ID NOS: 1 to 7” is not sufficient to describe the QTL on chromosome 8 which confers resistance to Hyaloperonospora brassicae because the specification [0130] clearly states that “these markers can be used to identify the presence of a QTL in plants grown from the deposit” and the plant of claim 1 is not the same as the plant grown from the deposit. 2) The plant of claim 1, however, reads on a genus of agronomically elite Brassica oleracea plants comprising a QTL on chromosome 8 which confers resistance to Hyaloperonospora brassicae , wherein the presence of the QTL can be identified by any one of SEQ ID NO: 1-7, wherein each sequence of SEQ ID NO: 1-7 is only 201 nucleotides in length. 3) The specification does not describe a single QTL on chromosome 8 by sequence structure or by specific location. 3) The specification neither provides a representative species nor refers to structure-function relation of the QTL that confers resistance to Hyaloperonospora brassicae , wherein the presence of the QTL can be identified by any one of SEQ ID NO: 1-7. 4) It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date" (AbbVie, 759 F.3d at 1298, reiterating Enzo Biochem, Inc., 323 F.3d at 964) (emphasis added). However, in the instant application, there is insufficient evidence of such an established structure-function correlation. Therefore, the specification 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 genus at the time of the filing of this application. 5) The sequences of SEQ ID NO: 1-7 are marker alleles and not QTLs.
Therefore, for all the reasons discussed above and in the last Office action, the claimed invention is not adequately described, and the rejection is proper.
Double Patenting
Claims 1, 5-16 and 48-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 and 25-32 and 37-41 of U.S. Patent No. 12,054, 728 B2. This rejection is repeated for the reasons of record as set forth in the last office action. Applicant’s arguments filed 04/28/2026 have been fully considered but are not deemed persuasive.
Applicant argues that the recitation that the QTL on chromosome 8 that can be identified by use of at least one marker selected from the group consisting of SEQ ID NO: 1 to 7 of the instant claims 1 is not obvious over the claims of the issued patent, requiring the QTL on chromosome 8 between SEQ ID NO: 1 and 7. This is not found persuasive because all the limitations recited in both the instant claims and issued patent claims are substantially similar, and Applicant provides no evidence to the contrary.
The claims of both the instant application and the issued patent are drawn to an agronomically elite Brassica oleracea plant that is resistant to Hyaloperonaspora brassicae, comprising a QTL on chromosome 8, 4 and 1, wherein the resistance is detectable in the cotyledon stage, wherein the presence of the QTL on chromosome 8 with the markers of SEQ TD NOS: 1 to 7; the plant further comprising a QTL on chromosome 4 with the markers of SEQ ID NO: 8-16 and/or a QTL on chromosome 1 with the markers of SEQ ID NO: 17-22; wherein when the QTLs that are homozygously present in the plant has an increased resistance to Hyaloperanospora brassicae as compared to the resistance Hyaloperonospora brassicae of a Brassica oleracea plant comprising only the OTL on chromosome 8; wherein said QTLs is as present in Brassica oleracea plant, sample of seed deposited under NCIMB Accession no. 43346; tissue culture, seed, cell, a progeny or a propagation material or a harvested part/processed product of said brassica plant and methods of introducing said QTLs into other brassica and selecting plants containing the QTLs.
Therefore, the claimed invention is obvious over the claims of the issued patent.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/
Primary Examiner, Art Unit 1662
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