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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/3/2026 has been entered.
Status of Claims
Claims 12, 19, 28 & 37-41 are under examination on the merits.
Claims 1-2, 8-11, 23-27 & 36 have been withdrawn.
The rejection of claims 12, 19, 28 & 37-41 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendments.
The rejections of claims 12, 19, 28 & 37-41 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for scope of enablement is withdrawn in light of Applicant’s amendments.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 (line 1): "plant" should be inserted after "rice".
Claim 12 (line 8): “subsp.” should not be italicized.
Claim 12 (line 9): “rice plant” should be inserted after “japonica”.
Claim 12 (line 9): "said OLLS1" should read --said polynucleotide encoding OLLS1--.
Appropriate correction is required.
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.
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 12, 19, 28 & 37-41 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. Dependent claims are included in the rejections.
Claim 40 recites the limitation "the cytoplasmic male sterile plant" in line 4. There is insufficient antecedent basis for this limitation in the claim, because claim 37 recites a male sterile plant but does not require the male sterile plant to be cytoplasmic male sterile.
Claim 12 requires a polynucleotide encoding OLLS1 set forth in SEQ ID NO: 2 wherein the polynucleotide is an introgression from accession IRGC92644 or IRGC110404. Although NIL_107B-12, which possesses the qSTGL8.0-OL from IRGC92664, has a sequence of SEQ ID NO: 2 (page 8, lines 11-27 & page 9, lines 8-23), OL_IRGC110404 has a sequence of SEQ ID NO: 1 (page 8, lines 11-27). The instant specification states that the coding sequences from these Oryza longistaminata accessions differ from each other (page 61, lines 3-14). Thus, it is not clear whether the plant of claim 12 requires a polynucleotide encoding OLSS1 set forth in SEQ ID NO: 2, which is found in an accession IRGC92664, or whether a plant comprising an OLLS1 introgression from accession IRGC110404, which would not comprise SEQ ID NO: 2, would also be encompassed by the claim. Because the material encompassed by the claim is unclear, claim 12 and dependent claims 19, 28 & 37-41 are indefinite.
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.
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 12, 19, 28 & 37-41 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 is a New Matter Rejection.
Claim 12 requires a polynucleotide encoding OLLS1 set forth in SEQ ID NO: 2 wherein the polynucleotide is an introgression from accession IRGC92644 or IRGC110404.
The originally filed disclosure provides an example of the O. longistaminata long stigma trait locus introgressed into two sets of commercial lines, IR58025A/B and IR68897A/B, from two different O. longistaminata accessions respectively, IRGC110404 and IRGC92664 (page 53, lines 9-15). The disclosure provides support for a line derived from the introgression of IRGC92664 comprising a polynucleotide encoding OLLS1 set forth in SEQ ID NO: 2 (NIL_107B-12, page 8, lines 11-27 & page 9, lines 8-23). However, the originally filed disclosure provides no support for an Oryza sativa rice plant comprising a polynucleotide encoding OLLS1 set forth in SEQ ID NO: 2 wherein said polynucleotide is an introgression from accession IRGC110404.
In addition, the disclosure does not provide support for plants comprising an introgression shorter than 150Kb over the full scope of the amended claims. The originally filed disclosure provides support for the introgression shorter than 350 or 300 Kb (page 4, lines 2-9) or shorter than 100 Kb (page 4, lines 21-22) or 230-350 Kb (page 52, line 31-page 53, line 5). The disclosure describes a fine-mapped region of 142 Kb (page 57, lines 2-7). However, a 142 kb introgression does not provide support for an introgression of 100,001-141,999 bases or 142,001-149,999 bases in length. While the broader genus of introgressions of the size of SEQ ID NO: 2 to 350kb is supported, the subgenera of introgressions of 100,001-141,999 bases and 142,001-149,999 bases are not supported.
Thus, claim 12 and dependent claims 19, 28 & 37-41 are drawn to material which constitutes new matter. In response to this rejection, Applicant is required to point to support for the concept or to cancel the new matter.
Applicant urges that example 2 supports introgression shorter than 150Kb, about 142 kb (Remarks, page 6, paragraph 10).
This argument is unpersuasive, because the originally filed disclosure did not contemplate plants comprising an introgression comprising a polynucleotide of SEQ ID NO: 2 that is shorter than 150Kb but longer than about 142Kb, or shorter than 142Kb and longer than 100Kb. Moreover, the originally filed disclosure does not provide support for an Oryza sativa rice plant comprising a polynucleotide encoding OLLS1 set forth in SEQ ID NO: 2 wherein said polynucleotide is an introgression from accession IRGC110404.
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.
Claim(s) 12, 19, 28, 37 & 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Jena et al US 2018/0160638 A1 (published 6/14/2018, more than 1 year prior to the filing date of the instant application, hereafter Jena) in view of Ali et al (2010) Rice. 3:218-234 (published 12/17/2010, hereafter Ali).
Claims 12, 19, 28, 37 & 39-41 are drawn to an Oryza sativa plant comprising a polynucleotide encoding OLLS1 set forth in SEQ ID NO: 2, wherein when said polynucleotide is an introgression, said introgression is from accession IRGC92644 or IRGC110404 and is shorter than 150 Kb and methods comprising said plant or a hybrid plant having said plant as an ancestor.
Claim 12 recites a plant comprising a polynucleotide of SEQ ID NO: 2; however, claim 12 also recites that the polynucleotide is an introgression from IRGC110404. The specification describes the introgression from IRGC110404 as having coding sequence differences from the introgression from accession IRGC92644 which comprises SEQ ID NO: 2 (page 61, lines 3-14). Thus, it is unclear if plants comprising the introgression from IRGC110404 according to claim 12 require SEQ ID NO: 2 or not. This rejection is based on the indefiniteness regarding whether plants comprising an introgression from IRGC110404 have or require SEQ ID NO: 2.
Jena teaches a motivation to improve outcrossing rates in rice for hybrid seed production, because hybrid rice has greater yields (paragraphs [0004-0007]). Jena teaches that O. longistaminata can be used for transfer of longer stigma into maintainer and CMS lines to increase hybrid rice seed production (paragraph [0220]). Jena teaches backcrossed lines transferring long stigma traits from accession number 110404 into maintainer line IR58025B (paragraphs [0221]). Introgressed lines had increased out crossing rates (paragraph [0226]).
Jena teaches a major QTL for stigma length on chromosome 8 from O. longistaminata accession number 110404, including sub QTLs located in regions of sizes 294 Kb and 171 kb (paragraphs [0229-0233], table 5). Jena teaches a method of backcrossing and phenotyping 4200 plants for stigma length to develop a linkage map (paragraphs [0229]).
Jena envisions a cultivated rice plant comprising an introgression associated with stigma length (Jena claim 1) and a hybrid rice plant having the rice plant as a parent or ancestor (Jena claim 12) and a method for increasing hybrid seed set comprising providing a cytoplasmic male sterile rice plant comprising the long stigma trait of O. longistaminata, pollinating the plant with pollen of a suitable restorer rice line, and enhancing hybrid rice seed set (Jena claim 45). Jena also envisions carrying out the method and collecting hybrid rice seed set (Jena claim 47) and a method of producing rice meal comprising growing and collecting seeds of the hybrid rice plant and processing the seeds to meal (Jena claim 49).
Jena does not teach a rice plant comprising an introgression that is shorter than 150 Kb or 100 Kb specifically, or that comprises the polynucleotide encoding OLLS1 and is SEQ ID NO: 2.
Ali teaches that wild Oryza species are reservoirs of genes conferring valuable qualitative and quantitative traits that would improve productivity, but that transferring such genes into cultivated rice without linkage drag or deleterious traits is difficult (page 229, right column, paragraph 4-page 230, left column, paragraph 1). Ali teaches that genetic potential of unadapted individuals is often obscured by the presence of deleterious alleles (page 223, left column, paragraph 1).
Before the filing of the instant application, it would have been obvious to one of ordinary skill in the art to cross an O. longistaminata plant of accession number 110404, which reads on IRGC110404, with an Oryza sativa cultivated rice plant, which reads on Oryza sativa subsp. japonica or indica, to reduce the size of the introgression. One of ordinary skill in the art would have been motivated to reduce the size of the introgression from O. longistaminata conferring a long-stigma phenotype in order to reduce linkage drag or potential deleterious traits. One of ordinary skill in the art would have had reasonable expectation of success, because crossing to reduce introgression size was a routine method prior to the instant filing date. In backcrossing to reduce linkage drag, some of the recovered plants would have been expected to comprise an introgression of less than 150 Kb or 100Kb.
Although Jena is silent with regard to a polynucleotide sequence with a sequence of SEQ ID NO: 2 encoding an OLSS1, the rice plants of Jena comprising the long stigma phenotype and comprising an introgression from an O. longistaminata plant of accession number 110404 would have comprised the polynucleotide sequence causative for the long stigma phenotype and therefore read on the plant of instant claims 12 & 19.
The hybrid plant envisioned by Jena claim 12 would make obvious the hybrid plant of instant claim 28.
The method for increasing hybrid seed set comprising providing a cytoplasmic male sterile rice plant comprising the long stigma trait of O. longistaminata, pollinating the plant with pollen of a suitable restorer rice line, and enhancing hybrid rice seed set (Jena claim 45) reads on the method of increasing hybrid seed set comprising providing a cytoplasmic male sterile plant of claim 12 and pollinating with pollen of a rice line, including a restorer line (instant claims 37 & 39). Collecting the hybrid seed set would have also been obvious (instant claim 40). Finally, Jena’s suggested method of producing rice meal comprising growing and collecting seeds of the hybrid rice plant and processing the seeds to meal (Jena claim 49) would have made obvious instant claim 41 because rice meal would comprise DNA of the hybrid plant.
Claim(s) 38 is rejected under 35 U.S.C. 103 as being unpatentable over Jena and Ali as applied to claims 12, 19, 28, 37 & 39-41 above, and further in view of Fan et al (2018) Plant Reprod. 31:3–14 (published 11/2/2017, hereafter Fan).
Claim 38 is drawn to a method wherein a male sterile plant is environment-sensitive genic male sterile.
The teachings of Jena and Ali are presented above. They do not teach a male sterile plant tha tis environment-sensitive male sterile.
Fan teaches that both cytoplasmic male sterility and environment-sensitive genic male sterility have been used extensively in hybrid breeding in rice (page 3, right column, paragraph 2-page 4, left column, paragraph 1; figure 1). Fan teaches that two-line hybrids, which are facilitated by availability of environment-sensitive genic male sterile germplasms, have advantages over three-line hybrids used in cytoplasmic male sterility, namely that environment-sensitive male sterile rice can propagate itself under permissive conditions, reducing labor, time, and resources in production, and such rice has a broad spectrum of restoration and do not require deliberately bred restorer lines (page 10, left column, paragraph 3-right column, paragraph 1).
Before the filing of the instant application, it would have been obvious to one of ordinary skill in the art to modify the cytoplasmic male sterile long stigma rice plant suggested by Jena with a rice plant comprising environment-sensitive genic male sterility. One of ordinary skill in the art would have been motivated to substitute environment-sensitive genic male sterility for cytoplasmic male sterility to enable a two-line hybrid system, reducing the required labor, time, and resources in production of hybrid rice. One of ordinary skill in the art would have had reasonable expectation of success, because environment-sensitive genic male sterility had been used extensively in hybrid breeding in rice prior to the filing of the instant application.
Claims 12, 19, 28 & 37-41 would have been obvious over Jena, Ali, and Fan.
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 12, 19, 28 & 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 & 8 of U.S. Patent No. US 10,999,986 B2 in view of Ali et al (2010) Rice. 3:218-234 (published 12/17/2010, hereafter Ali).
The instant claims are indefinite as to whether the claims encompass a plant comprising an introgression from Oryza longistaminata accession number 110404 comprising the region of the OLLS1 polynucleotide or whether the plant of the instant claims requires an introgression comprising SEQ ID NO: 2. This rejection is based on the interpretation that the claims do encompass plants comprising an introgression from Oryza longistaminata accession number 110404 comprising the region of the polynucleotide encoding OLLS1, which may or may not have SEQ ID NO: 2.
‘986 claim 1 is drawn to a cultivated rice plant comprising an introgression including at least one Oryza longistaminata dominant quantitative trait locus associated with stigma length, wherein said introgression is positioned on chromosome 8 and is defined by markers RM1109 and RM256. The introgression between RM256 and RM1109 is located on chromosome 8 and encompasses 3.89Mb, including the region comprising the OLLS1 gene of the instant invention (figure 9E of Jena).
‘986 claim 1 does not require that the introgression be shorter than 150 Kb or 100 Kb or comprise the polynucleotide encoding OLLS1.
Ali teaches that wild Oryza species are reservoirs of genes conferring valuable qualitative and quantitative traits that would improve productivity, but that transferring such genes into cultivated rice without linkage drag or deleterious traits is difficult (page 229, right column, paragraph 4-page 230, left column, paragraph 1). Ali teaches that genetic potential of unadapted individuals is often obscured by the presence of deleterious alleles (page 223, left column, paragraph 1).
Before the filing of the instant application, one of ordinary skill in the art would have been motivated to generate rice plants with smaller introgressions from Oryza longistaminata including a QTL associated with stigma length, including introgressions of 150 or 100Kb, in order to avoid linkage drag and deleterious alleles from the wild parent. One of ordinary skill in the art would have had reasonable expectation of success, because introgression was a routine method prior to the filing of the instant invention.
Although ‘986 claim 1 does not require that the Oryza longistaminata introgression is from accession number 110404, it would have been obvious to one of ordinary skill in the art to use a known, publicly available Oryza longistaminata as the donor for the quantitative trait locus associated with stigma length. A plant of accession number 110404 with an outcrossing rate of at least 60% (‘986 claim 1) would have the longer stigma phenotype and would inherently comprise the polynucleotide encoding the OLLS1 sequence. A cultivated rice plant reads on an Oryza sativa subspecies.
Thus, instant claims 12 & 19 are unpatentable over ‘986 claim 1.
Instant claim 28, drawn to a hybrid rice plant having the plant of claim 12 as an ancestor, comprising a polynucleotide encoding OLLS1, is unpatentable over ‘986 claim 4, drawn to a hybrid rice plant having the rice plant of claim 1 as a parent and comprising the dominant QTL.
Instant claim 41, drawn to a method of producing meal comprising growing and collecting seeds of the hybrid plant and processing seeds to meal, wherein the meal comprises DNA of the hybrid plant is unpatentable over ‘986 claim 8 drawn to a method of producing rice meal comprising growing and collecting seeds of the hybrid plant and processing said seeds to meal.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Victoria L DeLeo whose telephone number is (703)756-5998. The examiner can normally be reached M-F 8:00am-4pm EDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VICTORIA L DELEO/Examiner, Art Unit 1662
/Anne Kubelik/Primary Examiner, Art Unit 1663
Prosecution Insights