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 of Group III in the reply filed on 08/18/2026 is acknowledged. Because the applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
It is noted, however, that the Applicant amends claims including changing dependency of the claims previously belonging to other group(s), as described in the Office action dated 6/29/2026. Amended claims 2-8 are entered and being examined as part of Group. III.
The requirement is deemed proper and is therefore made FINAL.
Claim Status
Claims 2-20 are pending.
Claim 1 is cancelled by the Applicant.
Claims 9-12 and 14-20 are withdrawn from the examination as being part of non-elected groups.
Claim 2-8 and 13 are being examined.
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 2 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 2 depends from claim 13 and recites, “… the method further comprises: c. …”, while claim 13 already recites a step c. It is unclear if claim 2 is attempting to further restrict claim 13 by adding another step to the method that is not recited in claim 13, or if the claim is attempting to limit the “selecting” in step “c” of claim 13.
Claims 3-5 and 7 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.
Claims 3-5 and 7 recite “… displaced…”. For example, claim 3 recites “… screening for the presence of a displaced endogenous B. napus genomic segment on the telomeric end of chromosome N19, wherein the genomic segment is about 2,100 kb, and wherein the presence of the genomic segment contributes to a wildtype phenotype in B. napus” (emphasis added).
It is not clear to the Examiner what the Applicant imply by the term “displaced” in the context of claims 3-5 and 7. The Applicant describes, “… the about 2, l 00 kb endogenous B. napus sequence has been replaced by the Ogura Rf introgression and is absent in proprietary Ogura Rf germplasm” (spec, para 0089, line 17-19). So, a plant will have one or the other. If the 2,100 kb segment is detected, then it is not “displaced”. It is suggested to delete the term “displaced” from line 2 of claim 3.
Further regarding claim 4: line 2 recites, “the presence of the displaced N19 genomic segment”. There is insufficient antecedent basis for this limitation. Parent claim 13 does not mention any “displaced N19 genomic segment”, or screening for said segment.
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 2-8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US8766040B2) in view of Wang et al. (Genetic characterization of a new radish introgression line carrying the restorer gene for Ogura CMS in Brassica napus, 2020, PLoS ONE 15:e0236273), Lu et al. (Whole-genome resequencing reveals Brassica napus origin and genetic loci involved in its improvement, 2019, Nat. Commun., 10:1154).
The Applicant describes the truncated (or shortened) version of the Ogura (Ogu) nuclear fertility restorer (Rf) segment (truncated Rf segment) which can be used for canola (B. napus) hybrid seed production (spec, p.1, para 0002).
Patel et al. describes a method to fully restoring fertility in Ogura cytoplasmic male sterile (CMS) plants (abstract, line 3-6). The method of breeding can be used to shorten an exotic insertion comprising a gene of interest (abstract, last 2 lines) (including a Rf gene) in any plant (abstract, last 3 lines). Patel et al. teaches that a fertility restorer gene for Ogura cytoplasmic male sterile plants has been transferred from Raphanus sativus (radish) to Brassica napus (column 2, line 45-47). Patel et al. also teaches that when the Ogura Raphanus restorer gene was transferred from radish to Brassica, a large segment of the Raphanus genome was introgressed into Brassica as well (column 2, line 57-59). This large Raphanus genomic fragment carried many undesirable traits besides the restorer gene (column 2, line 60-61).
Patel et al describes several methods known in the art to remove the undesired linkage drag coming from the Raphanus genome. One of the methods removed approximately two thirds of the original Raphanus fragment (column 4, line 6-7) by making a single cross hybrid by using a homozygous restorer inbred line (column 3, line 65-66). Patel et al. also describes a shortened Raphanus fragment in their BLR1 recombination event. The BLR1 recombination event was produced solely by crossing and selection, followed by screening with molecular markers (column 4, line 42-46). However, the Raphanus fragment can be shortened further (column 4, line 47).
Patel et al. describes obtaining nucleic acid (DNA) samples from the plants (column 14, line 53-54) and screening the plants by performing PCR with a set of suitable representative markers (primers) and characterizing which markers were retained and which were lost (column 14, line 56-58).
However, Patel et al. does not describe any Rf gene introgressed into B. napus chromosome N19.
Wang et al. describes that the early version of Brassica Ogu restorer lines comprises a close linkage between glucosinolate (GSL) content and the Rf (Rfo) gene (p. 2, para 2, line 10-12). Wang et al. teaches a fertility restorer (Rf) gene, orf687, to be localized in the distal region on linkage group N19 (reads on to “telomeric end”, as recited in claim 3) in Pioneer-derived Ogu-CMS restorer line, which corresponds to the C genome in B. napus (p. 2, para 3, line 3-4). Wang et al. also describes the R9 linkage group (and its sequence) from R. sativus containing the Rfo gene sequences that were introgressed into the B. napus genome (p.4, para 8 in its entirety).
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to cross a B. napus male restorer line that contains the fertility restorer (Rf) gene, orf687, on chromosome N19, as described by Wang et al., with another B. napus female line that is male sterile (which does not have the Rf gene segment) followed by screening the F1 plants with molecular markers and probes to reduce the linkage drag of orf687 originating from radish (Raphanus) fragment. Both the Rfo genomic sequences from radish (GenBank accession No. AJ550021, published in 2009) (Wang et al.; p.4, para 9, line 1-2) and B. napus genomic sequence are known in the art (Lu et al.; title and abstract), published before the effective filing date of the invention. Screening F1 plants to detect the restorer gene (i.e., the truncated Rfo gene from radish introgressed into B. napus genome) could have been done in several well-known and standard methods used in the art and also described by Patel et al. (as discussed above).
One method to screen the F1 plants is by using DNA sequencing (as recited in claim 4), which may need forward and reverse primers (i.e., markers) and required probes to detect the specific amplified sequence in the wildtype canola genome vs the truncated Rf segment containing the restorer Rf gene, as recited in claims 7-8. The other method to screen would include routine PCR technique using forward and reverse primers (as recited in claims 5-6). Both the techniques along with designing specific primers are all well-known and routine processes in the art. Using any specific primers including SEQ ID NO: 4-5 and SEQ ID NOs: 7-8 (as recited in claim 6) and specific probes including SEQ ID NO: 3 and SEQ ID NO: 6 (as recited in claim 8), which are part of the Ogura Rf sequence, are experimental design choices of the artisan with a reasonable expectation of success without affecting the outcome for screening.
It would have been obvious to further reduce the size of the Ogura Rf segment as much as possible, leaving only the restorer Rf gene (Rfo gene or orf687; GenBank accession No. AJ550021), as described by Wang et al. ( p.4, para 9, line 1-2) and Patel et al. (column 4, line 22-28), to eliminate undesired loci that introgressed by linkage drag from the radish genome, as described by Patel et al. (column 4, line 6-7; line 29-30; line 42-47).
Using already known genetic markers around the Rfo gene in chromosome N19 in canola (B. napus), as described by Wang et al. (p.1, last para, line 11), and/or developing new genetic markers in fully sequenced B. napus genome and the R9 linkage group comprising the Rfo gene sequences from R. sativus, as described by Wang et al. (as discussed above), is a routine process which can be used in screening the F1 hybrids comprising shortened or truncated Ogura Rf segment of desired length while maintaining the radish Rfo gene segment in B. napus genome.
Before the effective filing date, an ordinarily skilled artisan would have been motivated to reduce linkage drag by crossing a B. napus male restorer line that contains the fertility restorer gene orf687, as described by Wang et al., with an elite B. napus female line (cultivar) that is male sterile but expressing low GSL content and/or other favorable agronomic properties such as high resistance to plant pathogens, good standability, high oil content, high yield, etc., to produce hybrids with low GSL content and/or other superior agronomic traits of the elite canola female parent.
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 2-8 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4 and 7 of U.S. Patent No. US8466347B2 (subsequently referred to as ‘347B) in view of Wang et al.
Reference claim 1 recites “a Brassica plant comprising a fertility gene for Ogura cytoplasmic male sterility, wherein the fertility gene is on a Raphanus fragment introgressed from Raphanus sativa …”. Reference claim 1 comprises any Brassica plant including B. napus. Reference claims 3-4 and 7 are drawn to the F1 progeny plants obtained by crossing the male fertility restored Brassica plant of claim 1, which includes B. napus plants, with a second plant (which also can be a B. napus plant) and wherein the F1 progeny plants comprise a shortened fragment of Ogura restorer gene originally obtained from Raphanus.
However, the claims 1, 3-4 and 7 of ‘347B (assignee Pioneer Hi Bred International Inc.), do not explicitly recite that the Rf gene fragment (introgressed from Raphanus sativus) is in chromosome N19.
Wang et al. describes that the early version of Brassica Ogu restorer lines comprises a close linkage between glucosinolate (GSL) content and the Rf (Rfo) gene (p. 2, para 2, line 10-12). Wang et al. also describes a fertility restorer (Rf) gene, orf687, to be localized in the distal region (reads on to “telomeric end”, as recited in claim 3) on linkage group N19 in Pioneer-derived Ogu-CMS restorer line, which corresponds to the C genome in B. napus (p. 2, para 3, line 3-4).
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to cross a B. napus male restorer line that contains the fertility restorer (Rf) gene, orf687, on chromosome N19, as described by Wang et al., with another B. napus female line that is male sterile (which does not have the Rf gene segment) followed by screening the F1 plants with molecular markers and probes to reduce the linkage drag associated with orf687 originating from radish (Raphanus). Both the Rfo gene sequences from radish (GenBank accession No. AJ550021, published in 2009) (Wang et al.; p.4, para 9, line 1-2) and B. napus genomic sequence are long known in the art. Screening the F1 plants to detect progeny plants comprising a shortened fragment of Ogura restorer gene (as recited in instant claim 13) is a routine process and also recited in claim 7 of ‘347B.
However, there are other well-known and routine methods to screen F1 plants. One such method uses DNA sequencing (as recited in claim 4), which would need forward and reverse primers (i.e., markers) (as recited in claims 5-6) and requires specific probes to detect the specific amplified sequence in the wildtype canola genome vs the truncated Rf segment containing the restorer Rf gene, as recited in claims 7-8, as discussed above. Probes (i.e., specific polynucleotide sequence) to detect the wildtype canola genome and the truncated Rf segment containing the restorer Rf gene can be designed using the known sequences of wildtype B. napus genome around that N19 locus and the sequence of Rf gene from radish. Using any specific primers including SEQ ID NO: 4-5 and SEQ ID NOs: 7-8 (as recited in claim 6) and specific probes including SEQ ID NO: 3 and SEQ ID NO: 6 (as recited in claim 8) are experimental design choices of the artisan with a reasonable expectation of success without affecting the outcome for screening.
Shortening the linkage drag by more than “about 5000 kb in length” (as recited in claims 13 and 2) and/or bringing back the “about 2100 kb in length” which was previously displaced endogenous B. napus genomic segment on the telomeric end of chromosome N19 (as recited in claim 3 and as interpreted above), which was previously displaced during introgression of the radish Rf gene, is an obvious experimental design choice of the artisan with a realistic objective to eliminate as much of the undesired linked sequence (of the radish genome linked to the Rfo gene (orf687), resulting in linkage drag), as possible; and preferably without having any linkage drag. In other words, shortening the linkage drag by more than “about 5000 kb in length” implies bringing back the “about 5000 kb in length” that comprises “about 2100 kb in length”, which was previously displaced in the endogenous B. napus genomic segment on the telomeric end of chromosome N19.
Before the effective filing date, an ordinarily skilled artisan would have been motivated to reduce linkage drag by crossing a B. napus male restorer line that contains the fertility restorer gene orf687, as described by Wang et al., with an elite B. napus female line (cultivar) that is male sterile but expressing low GSL content and/or other favorable agronomic properties such as high resistance to plant pathogens, good standability, high oil content, high yield, etc., to produce hybrids with low GSL content and/or other superior agronomic traits of the elite canola female parent.
Claims 2-8 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of U.S. Patent No. US 8,766,040 B2 (subsequently referred to as ‘040B) in view of Wang et al.
Reference claim 1 recites “a Brassica plant comprising a fertility gene for Ogura cytoplasmic male sterility, wherein the fertility gene is on a Raphanus fragment introgressed from Raphanus sativa …”. Reference claim 1 comprises any Brassica plant including B. napus. Reference claims 2-3 and 6 are drawn to the F1 progeny plants obtained by crossing the (male fertility restored) Brassica plant of claim 1, which includes B. napus plants, with a second plant (which also can be a B. napus plant) and wherein the F1 progeny plants comprise a shortened fragment and several markers are lacking in the F1 progeny plants (as recited in reference claim 3) of Ogura restorer gene originally obtained from Raphanus.
However, claims 1-3 and 6 of ‘347B (assignee Pioneer Hi Bred International Inc.), do not explicitly recite that the Rf gene fragment (introgressed from Raphanus sativus) is in chromosome N19.
Wang et al. describes that the early version of Brassica Ogu restorer lines comprises a close linkage between glucosinolate (GSL) content and the Rf (Rfo) gene (p. 2, para 2, line 10-12). Wang et al. also describes a fertility restorer (Rf) gene, orf687, to be localized in the distal region (reads on to “telomeric end”, as recited in claim 3) on linkage group N19 in Pioneer-derived Ogu-CMS restorer line, which corresponds to the C genome in B. napus (p. 2, para 3, line 3-4).
Before the effective filing date of the invention, it would have been obvious to an ordinarily skilled artisan to cross a B. napus male restorer line that contains the fertility restorer (Rf) gene, orf687, on chromosome N19, as described by Wang et al., with another B. napus female line that is male sterile (which does not have the Rf gene segment) followed by screening the F1 plants with molecular markers and probes to reduce the linkage drag associated with orf687 originating from radish (Raphanus). Both the Rfo gene sequences from radish (GenBank accession No. AJ550021, published in 2009) (Wang et al.; p.4, para 9, line 1-2) and B. napus genomic sequence are long known in the art. Screening the F1 plants to detect progeny plants comprising a shortened fragment of Ogura restorer gene (as recited in instant claim 13) is a routine process and also recited in claims 3 and 6 of ‘347B.
However, there are other well-known and routine methods to screen F1 plants. One such method uses DNA sequencing (as recited in claim 4), which would need forward and reverse primers (i.e., markers) (as recited in claims 5-6) and requires specific probes to detect the specific amplified sequence in the wildtype canola genome vs the truncated Rf segment containing the restorer Rf gene, as recited in claims 7-8, as discussed above. Probes (i.e., specific polynucleotide sequence) to detect the wildtype canola genome and the truncated Rf segment containing the restorer Rf gene can be designed using the known sequences of wildtype B. napus genome around that N19 locus and the sequence of Rf gene from radish. Using any specific primers including SEQ ID NO: 4-5 and SEQ ID NOs: 7-8 (as recited in claim 6) and specific probes including SEQ ID NO: 3 and SEQ ID NO: 6 (as recited in claim 8) are experimental design choices of the artisan with a reasonable expectation of success without affecting the outcome for screening.
Shortening the linkage drag by more than “about 5000 kb in length” (as recited in claims 13 and 2) and/or bringing back the “about 2100 kb in length” which was previously displaced endogenous B. napus genomic segment on the telomeric end of chromosome N19 (as recited in claim 3 and as interpreted above), which was previously displaced during introgression of the radish Rf gene, is an obvious experimental design choice of the artisan with a realistic objective to eliminate as much of the undesired linked sequence (of the radish genome linked to the Rfo gene (orf687), resulting in linkage drag), as possible; and preferably without having any linkage drag. In other words, shortening the linkage drag by more than “about 5000 kb in length” implies bringing back the “about 5000 kb in length” that comprises “about 2100 kb in length”, which was previously displaced in the endogenous B. napus genomic segment on the telomeric end of chromosome N19.
Before the effective filing date, an ordinarily skilled artisan would have been motivated to reduce linkage drag by crossing a B. napus male restorer line that contains the fertility restorer gene orf687, as described by Wang et al., with an elite B. napus female line (cultivar) that is male sterile but expressing low GSL content and/or other favorable agronomic properties such as high resistance to plant pathogens, good standability, high oil content, high yield, etc., to produce hybrids with low GSL content and/or other superior agronomic traits of the elite canola feGenbankmale parent.
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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J.C.
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
