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 .
Claim Status
Claims 10-13 are under examination on the merits.
Claims 1-9 have been cancelled.
Priority
Claims 10-13 receive the U.S. effective filing date of 04/04/2023.
Previous 101 rejection of claims 1-4 of the invention being drawn to a product of nature or natural phenomenon is withdrawn in view of Applicant’s amendments to the claims.
Previous 102(a)(1) rejection of claims 1-4 of the invention being anticipated by Yang is withdrawn in view of Applicant’s amendments to the claims.
Specification
The previous objection to the specification for inclusion of an unspecified trademark is withdrawn in view of Applicant’s amendments to the specification.
The disclosure remains objected to for containing an embedded hyperlink and/or other form of browser-executable code [Specification, p.7]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Applicant is advised to check whether language is browser-executable code by copy/pasting into a web browser – if the URL link returns a specific website, as opposed to returning general search results, then that hyperlink is browser-executable code. The National Center for Biotechnology Information (NCBI) is a well-known genetics resource and inclusion of its website URL is not necessary for the disclosure.
Applicant is advised to remove this URL.
Claim Objections
Claims 10-13 are objected to because of the following informalities:
1. Claims 10-13; typographical/grammatical errors; no comma should be included following use of the term ‘wherein’ [lines 2, all claims].
Appropriate correction is required.
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 10-12 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.
Claim 10 recites ‘re capable’ [line 5] and inclusion of ‘rest nutritive tissue sites’ [line 6]. The term ‘re capable’ is not defined and it is unclear what ‘rest’ indicates in the limitation drawn to tissue characteristics. No unique definitions are provided in the specification to clarify what either of these terms are referring to, nor is it stated in the claim language itself.
Applicant is advised to amend claim 10 and clarify or correct the meaning of the terms they are using to describe the scope of the claim.
Claim 11 recites the limitation "the rice dominant male sterile gene SMS" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 10 only recites “a dominant male sterile gene SMS”.
Applicant is advised to amend claim 10 so as to recite ‘a rice dominant male sterile gene SMS’.
Claim 11 is indefinite in claiming both a plant and a method of using it or making it. The claim is first drawn to a transgenic rice line (i.e. product) but then recites extraction of a gene (i.e. method). When a claim mixes statutory classes, it is unclear when a direct infringement occurs. See MPEP 2173.05(p) II.
Applicant is advised to amend claim 11 to recite only a product or only a method.
Claim 12 is indefinite because it is unclear what molecule(s) are encompassed by the claim. Option (2) recites limitations directed several encoding regions without clearly describing the intended limiting relationship(s) among the recited SEQ IDs. It is not clear what Applicant is intending to limit with such claim language.
Because of this, one would not be able to determine which nucleotides, or component sequences, are being referenced. It is unclear what the intended scope of Applicant’s claims are regarding particular molecular sequences. Because of this, one reading the claim would not have a clear indication of the metes and bounds of the claim limitation(s) intended by Applicant.
Applicant is advised to amend option (2) into more clearly understood subcategories or limiting statements regarding the intended relationship among genetic regions and/or molecules.
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.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yang [HEREDITAS (Beijing) May 2012, 34(5): 615-620; Published 2012] in view of Tian [Plant Breeding 120, 79-81 (2001); Published 06-22-2000] and Albertsen [US10155961; Published 06-04-2015].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 4 August 2025, as applied to the now cancelled claim 5. Applicant's arguments filed 30 October 2025 have been fully considered but they are not persuasive.
Claims 10-13 are drawn to breeding a transgenic rice overexpressing the SMS gene.
Yang teaches the SMS gene which causes dominant male sterility in rice. They teach the SMS gene sequence as being naturally occurring in monocots and widespread [p.2705, col.2, par.1-2]. Yang’s previous research disclosure identifies, names, and characterizes the function of this gene SMS in rice.
They teach the genetic location of SMS on chromosome 8 within a narrow, defined region of 99kb [‘Abstract’ and p.618, col.2, par.2], and describe the phenotypic effect of the gene on anther abortion [p.617, 2.1 Expression and inheritance of mutant traits, Figure 1]. It is clear that prior art teaches details of SMS as a potential tool for transferring male sterility phenotypes among different genetic backgrounds in rice.
Yang does not teach transgenic overexpression of SMS.
Tian and Albertsen teach the applied use of such genes, including their use as overexpressed transgenes, for breeding purposes.
Tian teaches the use of dominant male sterile genes (DMS) in breeding new varieties of cereal crops. They teach using a DMS source of germplasm in wheat, ‘Taigu’, to create new methods of hybrid seed production in a typically self-pollinated grain crop [Abstract; p.79, col.1, par.1; col.2, par.1]. Their disclosure is directed to traditional breeding methods (i.e. not transgenic) but clearly teaches how one would use a source of DMS ‘in breeding’ [p.79, col.1, par.2; p.81, col.1, par.2].
Albertsen further teaches applied use of DMS in transgenic breeding methods. They introduce DMS gene(s) into plant cells using an expression vector [col.62, par.4], reproductive tissue-specific promoters [col.63, par.2-3], and routine transformation methods. They produce DMS plants by way of such genetic transformation, and indicate one can overexpress a transgene to achieve the desired phenotype [col.68, par.2].
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the use of the SMS gene as taught by Yang to the applied method of developing a male sterile breeding line as described in the example of DMS wheat provided by Tian. Further, it would be obvious one would modify such uses to include those encompassing modern biotech methods. These methods of modern plant breeding including the use of transgenics, taught by Albertsen.
One would be motivated to combine these disclosures in order to create DMS rice that could be utilized similar to use of DMS in other grain crops. One would want to do this to enable controlled outcrossing of rice, thereby facilitating creation of male-sterile plants to be utilized in hybrid seed production. Similar to wheat, rice is a self-pollinated grain crop that researchers are interested in developing hybrid systems for. Rice researchers are interested in developing functionally ‘female’ (i.e. male sterile) plants to facilitate controlled crossing and production of hybrid seed. Rice researchers are interested in adapting tools, such as transgenic approaches, from already established, hybrid grain crops.
It is known in the art that DMS can be used in self-pollinated cereals such as wheat to enable production of valuable hybrid seed. Applying the similarly-functioning SMS gene described by Yang would be a predictable way to do replicate such valuable methods in rice. There would be strong practical and financial motivation to do this, as rice has an urgent need for improved yields through both introduction of genetic diversity and further development of hybrid production systems via use of such male sterility factors.
Response to Arguments
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant urges that Yang does not disclose a new rice line [Remarks, p.5, par.6].
This is not found persuasive because Yang clearly teaches development of a new rice line (i.e. germplasm or breeding line) in their mapping population. The parental line described was created by crossing the male sterile line ‘Sanming’ to the fertile line ‘Jiafuzhan’, resulting in creation of the new rice line ‘Jia sterile’ which is male sterile [Abstract; p.616, 1.1 Plant materials].
Additionally, they describe the generation of new rice lines in the form of germplasm comprising their BC1 mapping population, specifically 15 sterile and 15 fertile progeny lines [p.616, col.2, par.4].
Applicant urges that Yang only describes SMS as a naturally occurring gene (i.e. not transgenic and not overexpressed), and that other prior art is silent regarding overexpression of DMS gene SMS [Remarks, p.5, par.6].
This is not persuasive because the prior art of Albertsen cited in the previous Office action is clearly directed to teaching the use of transgenic DMS genes in plant breeding [col.62, par.4; col.63, par.2-3]. In addition to teaching use of transgenic approaches in breeding male sterile plants, generally, Albertsen explicitly teaches that one can overexpress the gene of interest to achieve the phenotype of interest [col.68, par.2]. They do not describe SMS per se because their research is not directed to rice; rather, it is teaches the methods of using male sterility in grain crops for hybridization purposes.
Furthermore, it is routine in the art of plant breeding, when using transgenic approaches, to overexpress target genes. It is known that overexpression of a transgene can potentially result in a greater, or more desirable, phenotypic response. This would be both obvious to try and routine to a plant breeder.
Applicant urges that prior art does not teach overexpression as a means of generating a transgenic DMS phenotype [Remarks, p.5, par.8].
This is not persuasive because the prior art of Albertsen cited in the previous Office action is clearly directed to teaching the use of transgenic DMS genes in plant breeding [col.62, par.4; col.63, par.2-3]. In addition to teaching use of transgenic approaches in breeding male sterile plants, generally, Albertsen explicitly teaches that one can overexpress the gene of interest to achieve the phenotype of interest [col.68, par.2]. They do not describe SMS per se because their research is not directed to rice; rather, it is teaches the methods of using male sterility in grain crops for hybridization purposes.
Furthermore, it is routine in the art of plant breeding, when using transgenic approaches, to overexpress target genes. It is known that overexpression of a transgene can potentially result in a greater, or more desirable, phenotypic response. This would be both obvious to try and routine to a plant breeder.
Applicant urges non-obviousness because claim 10 includes a morphological description of the effects of the SMS gene. They argue that morphology of transgenic lines is highly unpredictable, thus their proposed invention is non-obvious [p.5, par.9].
This is not found persuasive because Yang describes the strong effect of SMS on anther abortion. “The sterility was very thorough…and had nothing to do with the genetic background” [p.617, 2.1 Expression of mutant traits].
Thus, the SMS gene is described as dominant and behaving in a qualitative (i.e. discrete non-quantitative phenotype) manner. Applicant’s specification further supports the predictable phenotypic effect of SMS [Specification, par.138]. Absent evidence to the contrary, one would expect SMS to confer male sterility due to its apparently inherent and complete effects on anther development. No such evidence identifying variable effects due to genetic background, environmental, or other factors is indicated by the disclosure or the relevant background literature surrounding SMS.
Furthermore, Applicant’s argument regarding unpredictable morphological outcomes, directed to transgenics, is made without reference to any citations or supporting evidence pertinent to SMS or DMS genes. Applicant merely presents an opinion that in some hypothetical scenarios an alternate outcome may arise. This opinion stands in contrast to their own disclosure, and the teachings of the prior art.
As such, Applicant’s argument is unconvincing.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Anne Kubelik/Primary Examiner, Art Unit 1663