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
1. Applicant’s election with traverse of Group I, claims 1-7, 9-14 and anthocyanin gene C in the paper filed on March 20, 2026 is acknowledged.
Applicant primarily argues that Office has failed to address the issue of serious search and/or examination burden. Applicant further argues that Ren et al. teach that OsPTD1 comes from a different locus than the claimed invention (response, pages 7-8).
Applicant’s arguments are carefully considered but are deemed to be unpersusaive.
It is important to note that the instant application is a national stage entry of a PCT
Application ( PCT/CN2021/114635, filed 08/26/2021) and is subject to restriction requirement under
35 U.S.C. 121 and 372. Furthermore, the breadth of parent claim (see for example, claim 1) reads on any male fertile and/or gametophyte male fertile gene. Accordingly, it is maintained that Wu et al. (Plant Cell Rep., 33:18881-1899, 2014;IDS) teach an ABC transporter gene OsABCG15 encoding a membrane protein which is essential for normal development of pollen in rice. See in particular, abstract, figure 5 at page 12, figures 9 at page 18, Figures 1-4, 6-8. It is further maintained that Zhang et al. (CN 102586278 A Southern University, pages 1-28, Published July 18, 2018; IDS) teach OsABCG15 gene essential for normal pollen development. See in particular, abstract. Additionally, Ren et al. (The Plant Journal, 98:315-328, Published December 27, 2018, supplementary documents attached) teach OsPTD1 gene (gametophyte male fertile gene) is required for normal pollen development. See in particular, last two paragraphs of right column at page 320 through the end of first paragraph at page 322, Figures S1e, Figure S1f, Figure 6a, b, j, k; (Figure 6c-e, I, n), Table S5).
Thus, claims 1-7 and 9-14 are pending. Applicant has cancelled non-elected claims 8 and 15-20 (Group II) and non-elected species down-regulation element Ci in the response filed in the papers of March 20, 2026.
Accordingly, claims 1-7 and 9-14 in conjunction with elected species anthocyanin gene C are examined on merits in the present Office action. This restriction is made FINAL.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Information Disclosure Statement
2. Initialed and dated copies of Applicant’s IDS form 1449 filed in the papers of February 27, 2023 and August 4, 2023 are attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
3. Claims 1-7 and 9-14 are rejected under 35 U.S.C. 112(a), 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(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has recently clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id.
Finally, the court held:
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 a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. Id.
See also MPEP Section 2163, page 174 of Chapter 2100 of the August 2005 version, column 1, bottom paragraph, where it is taught that
[T]he claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
See also Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1016 at 1021, (Fed. Cir. 1991) where it is taught that a gene is not reduced to practice until the inventor can define it by "its physical or chemical properties" (e.g. a DNA sequence).
Claims are broadly drawn to a method for breeding a recessive genetic male sterile line of a sporophyte, comprising the following steps: linking a sporophyte male fertile gene Y, a down-regulation expression element Xi of an endogenous gametophyte male fertile gene, a herbicide A resistance gene AR, a down-regulation element Bi of a herbicide B resistance gene, an anthocyanin gene, and transferring the linked genes into a sterile mutant of the sporophyte male fertile gene Y, and pollinating a sterile plant with a positive plant to breed a genetic sterile line of a sporophyte, or wherein the method comprising the following steps: (1) constructing a vector pAR-Xi-Y-Bi-C containing the herbicide A resistance gene AR, thR is a Bar gene resistant to Basta; the herbicide B resistance gene is a Bel gene resistant to bentazone, and thsporophyte male fertile gene Y is an essential gene, an OsABCG15 gene, for pollen development of paddy rice the down- regulation expression element Xi of thspraying Basta and bentazone, performing hybridization using a plant resistant to the Basta as a male parent and a plant resistant to the bentazone as a female parent, and harvesting hybrid seeds to obtain the sterile line, or wherein the method comprising breeding a sterile line and comprising the following steps: dividing the selfed seeds of the male fertile transgenic plant into two parts, respectively spraying Basta and the bentazone, performing hybridization using a plant resistant to the Basta as a male parent and a plant resistant to the bentazone as a female parent, and harvesting hybrid seeds to obtain the sterile line, or wherein the method further comprising identifying and purifying the sterile line and comprising the following steps: after sowing the sterile line, investigating a ratio of the colorless plant according to the existence of the anthocyanin color to obtain a purity of the sterile line, and when the purity is non-conformity, spraying the herbicide B to kill a colored and herbicide-intolerant different plant to obtain a sterile line with a sterile plant rate of 100%, or wherein the method further comprising identifying and purifying the sterile line and comprising the following steps: after sowing the sterile line, investigating a ratio of the colorless plant according to the existence of the anthocyanin color to obtain a purity of the sterile line, and when the purity is non-conformity, spraying the herbicide B to kill a colored and herbicide-intolerant different plant to obtain a sterile line with a sterile plant rate of 100%, or wherein the method further comprising breeding a maintainer line and comprising the following steps: collecting selfed seeds of a hybrid male parent, sowing the selfed seeds, and selecting a colored plant or a plant surviving after the herbicide A is sprayed as a maintainer line, or wherein the method further comprising breeding a maintainer line and comprising the following steps: collecting selfed seeds of a hybrid male parent, sowing the selfed seeds, and selecting a colored plant or a plant surviving after the herbicide A is sprayed as a maintainer line.
Breadth of claims 1 and 2 encompasses: (i) any sporophyte male fertile gene designated Y derived from any species, (ii) any down-regulation element derived from any source and designated Xi of any endogenous gametophyte male fertile gene derived from any species, (iii) any herbicide A resistance gene designated AR derived from any source, (iv) any down-regulation element designated Bi of any herbicide designated B resistance gene from any source, and (v) any anthocyanin gene C derived from any species, and having the function of breeding for any recessive genetic sterile line in in any plant species.
Breadth of claim 3 encompasses: (i) an OsABCG15 gene with any sequence, (ii) any interference sequence directed to any endogenous gametophyte male fertile gene OsPTD1, (iii) any Bar gene derived from any source to provide resistance to Basta in any plant species, (iv) any interference sequence directed to any endogenous Bel gene in any plant species to provide resistance bentazone herbicide, and (v) any anthocyanin gene OsMYB76R sequence, and having the function of breeding for any recessive genetic sterile line in in any species.
Breadth of claim 4 reads on any sequence because recitations (see underlined) of phrases “a nucleotide sequence of the Bar gene is shown in SEQ ID NO. 6” “a sequence of the down-regulation element Bi of the herbicide B resistance gene is shown in SEQ ID NO. 18; “a nucleotide sequence of the OsABCG15 gene is shown in SEQ ID NO. 17”; non-specific “interference sequence of the gametophyte male sterility-related gene OsPTD1 gene is shown in SEQ ID NO. 20”; and “a nucleotide sequence of the pigment expression related gene OsMYB76R gene is shown in SEQ ID NO. 11. It may be noted recitations “a nucleotide sequence” or “a sequence” reads on any sequence having just 2 nucleotide sequence of SEQ ID NOs recited in the claim.
The breadth and scope of claims encompasses a very large genus having unknown and undescribed structures, whose expression may be modified to obtain instantly claimed function.
The instant specification however, only describes a method of creating a plant transformation vector comprising multigene construct designated pAR-Xi-Y-Bi-C, wherein (i) AR is a Basta resistance coding gene (Bar) sequence as set forth in SEQ ID NO: 6, and SEQ ID NO: 6 encodes Phosphinothricin N-acetyltransferase protein for providing resistance to Basta herbicide; (ii) Xi is the interference element of the endogenous OsPTD1 gene of rice comprising the OsPTD1 native promoter as set forth in shown in SEQ ID NO: 2 operably linked to the endogenous rice OsPTD1 gene interference target forward sequence as set forth in SEQ ID NO: 3 which is operably linked to a stem-loop sequence as set forth in SEQ ID NO. 4 which is operably linked to the endogenous OsPTD1 gene interference target reverse sequence as set forth in SEQ ID NO: 19 and which is further operably linked to the terminator Tnos sequence as set forth in SEQ ID NO. 5. The complete nucleotide sequence Xi was shown in the SEQ ID NO. 20; (iii) Y is rice OsABCG15 gene (artificially synthesized by removing introns) coding sequence as set forth in SEQ ID NO: 17; (iv) Bi is the interference element of rice endogenous bentazone resistance gene Bel which was artificially synthesized comprising the Bel native promoter as set forth in SEQ ID NO. 10 which is operably linked to the Bel gene interference target sequence as set forth in SEQ ID NO. 9 which is operably linked to the Tnos terminator as set forth in SEQ ID NO. 5). The complete sequence Bi is set forth in SEQ ID NO.18; and (v) C is the rice OsMYB76R gene sequence as set forth in SEQ ID NO: 11. The specification further describes a male sterile rice mutant naturally generated by an OsABCG15 gene which was used as a sterile donor, rice Zhongjiu B as a recurrent parent, and a sporophyte sterile material Zhongjiu B-osabcg15 was generated by multiple backcross. The specification further describes that the plant transformation vector comprising multigene construct designated pAR-Xi-Y-Bi-C was transformed into rice Zhongjiu B-osabcgl5 followed by breeding and purity identification and improvement of genetic male sterile Zhongjiu B-osabcgl5 of sporophyte. See in particular, example 1 at pages 7-12 of the specification and Figures 1-2.
The state of the art for inferring a structure function relationship based on sequence homology is highly unpredictable. The functional prediction of a protein based on structural comparison is not consistent with an empirical assessment of its function. See for example, Doerks et al., (TIG, 14:248-250, 1998) who teach that sequence homology is not sufficient to determine functionality of an uncharacterized protein. The homologs that scored best in PSI-BLAST analysis failed to share same catalytic activity. The reference clearly emphasizes that computer analysis of genome sequences is flawed, and overpredictions are common because the highest scoring database protein does not necessarily share the same or even similar functions. See in particular, page 248, 1st paragraph; page 248, right column, 2nd paragraph.
Also see Smith et al. (Nature Biotechnology, 15:1222-1223, 1997) who teach that there are numerous cases in which proteins of very different functions are homologous. See in particular, page 1222, last paragraph.
Also see Bork et al. (TIG, 12:425-427, 1996) who teach that homology search methods are stretched and spurious hits are taken as real. The reference further teaches that similarities determined by homology search might only be restricted to certain domains of the uncharacterized protein, whereas the whole protein is required for the functionality of the protein. See page 426, right column, 1st paragraph.
The specification does not describe the structure for representative members of Applicant’s broadly claimed genus comprising variants derived from diverse sources as encompassed by the breadth of claims and thus the instantly claimed function of breeding a recessive genetic male sterile line of a sporophyte is either unknown or unpredictable.
The only species described in the specification is from rice as set forth in the multigene construct designated as pAR-Xi-Y-Bi-C which comprises SEQ ID NOs: 6, 11, 17, 18 and 20.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, transgenic expression of pAR-Xi-Y-Bi-C which comprises SEQ ID NOs: 6, 11, 17, 18 and 20.
as described in the instant specification is insufficient to describe the claimed genus.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
4. Claims 1-7 and 9-14 are rejected under first paragraph of 35 U.S.C. 112(a), because the specification, while being enabling for a method for breeding a recessive genetic male sterile line of a rice sporophyte, comprising transforming a rice male sterile mutant plant Zhongjiu B-osabcgl5 carrying mutation in endogenous OsABCG15 gene with a plant transformation vector designated as pAR-Xi-Y-Bi-C which comprises the multigene(s) construct having the nucleotide sequences as set forth in SEQ ID NOs: 6, 11, 17, 18 and 20, wherein expression of said multigene(s) constructs followed by breeding and purity identification and improvement of genetic male sterile Zhongjiu B-osabcgl5 of sporophyte, results in the production of a recessive genetic male sterile line of a rice sporophyte, does not reasonably provide enablement for (i) any sporophyte male fertile gene designated Y derived from any species, including any OsABCG15 gene with any sequence, (ii) any down-regulation element derived from any source and designated Xi of any endogenous gametophyte male fertile gene derived from any species, including any interference sequence directed to any to any endogenous gametophyte male fertile gene OsPTD1 (iii) any herbicide A resistance gene designated AR derived from any source, including any Bar gene derived from any source to provide resistance to Basta in any plant species (iv) any down-regulation element designated Bi of any herbicide designated B resistance gene from any source, including any interference sequence directed to any endogenous Bel gene to provide resistance bentazone herbicide, (v) any anthocyanin gene C derived from any species including any anthocyanin gene OsMYB76R sequence, and (vi) producing a recessive genetic rice male sterile line of a sporophyte using any method that does not involve transformation with a plant transformation vector designated as pAR-Xi-Y-Bi-C which comprises said multigene(s) construct. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
Claims are broadly drawn to a method for breeding a recessive genetic male sterile line of a sporophyte, comprising the following steps: linking a sporophyte male fertile gene Y, a down-regulation expression element Xi of an endogenous gametophyte male fertile gene, a herbicide A resistance gene AR, a down-regulation element Bi of a herbicide B resistance gene, an anthocyanin gene, and transferring the linked genes into a sterile mutant of the sporophyte male fertile gene Y, and pollinating a sterile plant with a positive plant to breed a genetic sterile line of a sporophyte, or wherein the method comprising the following steps: (1) constructing a vector pAR-Xi-Y-Bi-C containing the herbicide A resistance gene AR, thR is a Bar gene resistant to Basta; the herbicide B resistance gene is a Bel gene resistant to bentazone, and thbackcross using a male sterile mutant naturally generated by the OsABCG15gene as a sterile donor and Zhongjiu B as a recurrent parent, or wherein a nucleotide sequence of the Bar gene is shown in SEQ ID NO. 6; a sequence of the down-regulation element Bi of the herbicide B resistance gene is shown in SEQ ID NO. 18; a nucleotide sequence of the OsABCG15 gene is shown in SEQ ID NO. 17; “interference sequence of the gametophyte male sterility-related gene OsPTD1 gene is shown in SEQ ID NO. 20; and a nucleotide sequence of the pigment expression related gene OsMYB76R gene is shown in SEQ ID NO. 11, or wherein the method comprising breeding a sterile line andand a plant resistant to the bentazone as a female parent, and harvesting hybrid seeds to obtain the sterile line, or wherein the method further comprising identifying and purifying the sterile line and comprising the following steps: after sowing the sterile line, investigating a ratio of the colorless plant according to the existence of the anthocyanin color to obtain a purity of the sterile line, and when the purity is non-conformity, spraying the herbicide B to kill a colored and herbicide-intolerant different plant to obtain a sterile line with a sterile plant rate of 100%, or wherein the method further comprising identifying and purifying the sterile line and comprising the following steps: after sowing the sterile line, investigating a ratio of the colorless plant according to the existence of the anthocyanin color to obtain a purity of the sterile line, and when the purity is non-conformity, spraying the herbicide B to kill a colored and herbicide-intolerant different plant to obtain a sterile line with a sterile plant rate of 100%, or wherein the method further comprising breeding a maintainer line and comprising the following steps: collecting selfed seeds of a hybrid male parent, sowing the selfed seeds, and selecting a colored plant or a plant surviving after the herbicide A is sprayed as a maintainer line, or wherein the method further comprising breeding a maintainer line and comprising the following steps: collecting selfed seeds of a hybrid male parent, sowing the selfed seeds, and selecting a colored plant or a plant surviving after the herbicide A is sprayed as a maintainer line.
Breadth of claims 1 and 2 encompasses: (i) any sporophyte male fertile gene designated Y derived from any species, (ii) any down-regulation element derived from any source and designated Xi of any endogenous gametophyte male fertile gene derived from any species, (iii) any herbicide A resistance gene designated AR derived from any source, (iv) any down-regulation element designated Bi of any herbicide designated B resistance gene from any source, and (v) any anthocyanin gene C derived from any species, and having the function of breeding for any recessive genetic sterile line in in any species.
Breadth of claim 3 encompasses: (i) an OsABCG15 gene with any sequence, (ii) any interference sequence directed to any endogenous gametophyte male fertile gene OsPTD1, (iii) any Bar gene derived from any source to provide resistance to Basta in any plant species, (iv) any interference sequence directed to any endogenous Bel gene in any plant species to provide resistance bentazone herbicide, and (v) any anthocyanin gene OsMYB76R sequence, and having the function of breeding for any recessive genetic sterile line in in any species.
Breadth of claim 4 reads on any sequence because recitations (see underlined) of phrases “a nucleotide sequence of the Bar gene is shown in SEQ ID NO. 6” “a sequence of the down-regulation element Bi of the herbicide B resistance gene is shown in SEQ ID NO. 18; “a nucleotide sequence of the OsABCG15 gene is shown in SEQ ID NO. 17”; non-specific “interference sequence of the gametophyte male sterility-related gene OsPTD1 gene is shown in SEQ ID NO. 20”; and “a nucleotide sequence of the pigment expression related gene OsMYB76R gene is shown in SEQ ID NO. 11. It may be noted recitations “a nucleotide sequence” or “a sequence” reads on any sequence having just 2 nucleotide sequence of SEQ ID NOs recited in the claim.
However, the instant specification only provides guidance only on a method of creating a plant transformation vector comprising multigene construct designated pAR-Xi-Y-Bi-C, wherein (i) AR is a Basta resistance coding gene (Bar) sequence as set forth in SEQ ID NO: 6, and SEQ ID NO: 6 encodes Phosphinothricin N-acetyltransferase protein for providing resistance to Basta herbicide; (ii) Xi is the interference element of the endogenous OsPTD1 gene of rice comprising the OsPTD1 native promoter as set forth in shown in SEQ ID NO: 2 operably linked to the endogenous rice OsPTD1 gene interference target forward sequence as set forth in SEQ ID NO: 3 which is operably linked to a stem-loop sequence as set forth in SEQ ID NO. 4 which is operably linked to the endogenous OsPTD1 gene interference target reverse sequence as set forth in SEQ ID NO: 19 and which is further operably linked to the terminator Tnos sequence as set forth in SEQ ID NO. 5. The complete nucleotide sequence Xi was shown in the SEQ ID NO. 20; (iii) Y is rice OsABCG15 gene (artificially synthesized by removing introns) coding sequence as set forth in SEQ ID NO: 17; (iv) Bi is the interference element of rice endogenous bentazone resistance gene Bel which was artificially synthesized comprising the Bel native promoter as set forth in SEQ ID NO. 10 which is operably linked to the Bel gene interference target sequence as set forth in SEQ ID NO. 9 which is operably linked to the Tnos terminator as set forth in SEQ ID NO. 5). The complete sequence Bi is set forth in SEQ ID NO.18; and (v) C is the rice OsMYB76R gene sequence as set forth in SEQ ID NO: 11. The specification further describes a male sterile rice mutant naturally generated by an OsABCG15 gene which was used as a sterile donor, rice Zhongjiu B as a recurrent parent, and a sporophyte sterile material Zhongjiu B-osabcg15 was generated by multiple backcross. The specification further describes that the plant transformation vector comprising multigene construct designated pAR-Xi-Y-Bi-C was transformed into rice Zhongjiu B-osabcgl5 followed by breeding and purity identification and improvement of genetic male sterile Zhongjiu B-osabcgl5 of sporophyte. See in particular, example 1 at pages 7-12 of the specification and Figures 1-2.
The breadth of claims encompass any sporophyte male fertile gene designated “Y” from any source. The breadth of claims also encompass any endogenous gametophyte male fertile gene from any source to be targeted by any down-regulation element and designated as Xi. Furthermore, claims also encompass any herbicide A gene from any source and designated as AR, and claims also encompass any herbicide B gene from any source to be targeted by any down-regulation element and designated as Bi, and additionally claims do encompass any anthocyanin gene from any source and designated as C. Also breadth of claim 4 reads on any sequence from any source and having just 2 nucleotides of recited SEQ ID NOs.
In light of breadth and scope of instantly claimed elements discussed above, the claims do read on protein(s) or polypeptides from any source with either to be overexpressed (Y and C elements of claims) or to be targeted for down-regulation (Xi and Bi elements). This would encompass proteins or polypeptides having large number of amino acid substitutions that are intended to be overexpressed or to be targeted for down-regulation.
The state of the art for inferring a structure function relationship based on sequence homology is highly unpredictable. The functional prediction of a protein based on structural comparison is not consistent with an empirical assessment of its function. See for example, Doerks et al., (TIG, 14:248-250, 1998) who teach that sequence homology is not sufficient to determine functionality of an uncharacterized protein. The homologs that scored best in PSI-BLAST analysis failed to share same catalytic activity. The reference clearly emphasizes that computer analysis of genome sequences is flawed, and overpredictions are common because the highest scoring database protein does not necessarily share the same or even similar functions. See in particular, page 248, 1st paragraph; page 248, right column, 2nd paragraph.
Also see Smith et al. (Nature Biotechnology, 15:1222-1223, 1997) who teach that there are numerous cases in which proteins of very different functions are homologous. See in particular, page 1222, last paragraph.
Also see Bork et al. (TIG, 12:425-427, 1996) who teach that homology search methods are stretched and spurious hits are taken as real. The reference further teaches that similarities determined by homology search might only be restricted to certain domains of the uncharacterized protein, whereas the whole protein is required for the functionality of the protein. See page 426, right column, 1st paragraph.
While it is known that many amino acid substitutions, additions or deletions are generally possible in any given protein the positions within the protein's sequence where such amino acid changes can be made with a reasonable expectation of success (without altering protein function) are limited. Certain positions in the sequence are critical to the protein's structure/function relationship, e.g. such as various sites or regions directly involved in binding, activity and in providing the correct three-dimensional spatial orientation of binding and active sites. These regions can tolerate only relatively conservative substitutions or no substitutions (see for example, Wells, Biochemistry 29:8509-8517, 1990, see pages 8511-8512, tables 1-2; Ngo et al., pp. 492-495,1994, see page 491, 1st paragraph).
Also, see Guo et al. (PNAS, 101: 9205-9210, 2004, see page 9205, abstract; page 9206, table 1; page 9208, figure 1) who teach that there is a probability factor of 34% that a random amino acid replacement in a given protein will lead to its functional inactivation. In the instant case, such a probability factor will be much higher as the claims encompass more than a single amino acid changes in the encoded protein as encompassed by the breadth and scope of claims.
Also see, Keskin et al. (Protein Science, 13:1043-1055, 2004, see page 1043, abstract) who teach that proteins with similar structure may have different functions. Furthermore, Thornton et al. (Nature structural Biology, structural genomics supplement, November 2000, page 992, 2nd paragraph bridging columns 1 and 2) teach that structural data may carry information about the biochemical function of the protein. Its biological role in the cell or organism is much more complex and actual experimentation is needed to elucidate actual biological function under in vivo conditions.
Applicant is reminded that even in cases where a protein with a known function is expressed in a plant can produce unpredictable results. For example, Nishimura et al. (Plant Cell Physiol., 41(5):583-590, 2000; see in particular, abstract) describe over-expression of NTH15 and NTH20 proteins (transcription factors) in a transgenic plant resulted in abnormal leaf morphology.
Also see Yang et al. (PNAS, 98:11438-11443, 2001; abstract; pages 11442-11443) who teach that transgenic rice plants constitutively overexpressing REB transcription factor resulted in sterile transgenic plants.
See also McConnell et al. (Nature, 411:709-713, 2001; see in particular, abstract; figure 2) who teach that a single amino acid change (glycine to aspartic acid) in START domain of either PHABULOSA or PHAVOLUTA (homeodomain leucine zipper domain containing transcription factor) was sufficient to alter sterol/lipid binding domain activity.
Thus, making and analyzing proteins with large and unspecified amino acid changes that have functional activity of a fully-functional protein and still exhibiting functional activity to produce desired traits in plant as claimed would require undue experimentation.
Given the claim breath, unpredictability, and lack of guidance as discussed above, undue experimentation would have been required by one skilled in the art to develop and evaluate nucleic acids encoding proteins having large and unspecified changes in the encoded proteins encompassed by the claims
In the absence of guidance, undue trial and error experimentation would be required to screen through the myriad of nucleic acids encompassed by the claims and plants transformed therewith, to identify those that produce desired traits in a corn plant as claimed would require undue experimentation. See Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 at page 1027, where it is taught that the disclosure of a few gene sequences did not enable claims broadly drawn to any analog thereof.
The instantly claimed invention encompasses using sense, antisense, RNAi, micro RNA, CRISPR/Cas9 etc. based gene suppression methods to decrease expression of endogenous genetic elements, such as Xi and Bi as instantly claimed and further discussed above.
Using DNA sequences to reduce expression of the endogenous corresponding gene through the mechanism of sense suppression produces unpredictable results. See for example, Gutterson (HortScience 30:964-966,1995) who teaches that the chrysanthemum and petunia chalcone synthase (CHS) genes are 70% identical to each other, and that transforming petunia plants with the chrysanthemum CHS gene did not co-suppress the endogenous petunia CHS gene (page 965, left column, second paragraph). Gutterson reports similar data using another petunia gene in the anthocyanin pathway. Also see Bruening (Proc. Natl. Acad. Sci., 95:13349-13351, 1998) who teaches that the occurrence of gene silencing by sense suppression may be the unwanted outcome when goal is overexpression, and only few silenced plant lines may appear, and such lines generally will not hold to character when propagated by seed (see in particular, page 13350, lines 10-14).
Antisense suppression of gene expression is highly unpredictable, and the prior art suggests that success depends on the % identity between the sequence of the antisense construct and the target gene sequence. See Elomaa et al. (Molecular Breeding, 2:41-50, 1996; paragraph bridging pages 47-48, in particular). Also see Colliver et al. (Plant molecular Biology, 35:509-522, 1997) who teach that down-regulating the expression of a gene family through antisense method is highly unpredictable. Colliver et al. showed that transformation of bird's foot trefoil with a construct that was antisense to bean chalcone synthase resulted in transformants with increased levels of chalcone synthase transcripts due to increased transcription of other members of the gene family (see page 519 left column paragraph 2, in particular).
The state-of-the-art teaches antisense molecules require 100% base pair conservation between the antisense molecule and its target. The Office contends that antisense and co-suppression operate by the same mechanism. Emery et al. (Current Biology 13:1768-1774, 2003) teach experiments in which a target sequence of a micro-RNA (miRNA) was changed by two base-pairs. The altered base-pairs caused the complementary micro-RNA not to bind to the target sequence, which subsequently led to an increased expression of the target sequence's encoded protein (page 1769, right column, 2nd full paragraph). Also see Nunes et al. (Planta 224:125-132; 2006) who teach that transforming plants with a RNAi construct comprising a nucleic acid encoding a Glycine max myo-inositol-1-phosphate synthase. Nunes et al disclose an absence of seed development in those plants in which the phytate content was reduced (abstract).
Furthermore, using DNA sequences to reduce expression of the endogenous corresponding gene using RNAi based suppression methods is highly unpredictable. See for example, Arziman et al. (Nucleic Acids Research, 33:582-588, 2005; see in particular abstract and introduction) who teach that although a dsRNA should be designed to match to one specific gene, off-target effects can occur if siRNAs have sequence homology to genes that are not supposed to be targeted. The knock-down of target might differ depending on the efficiency of siRNA derived from long dsRNA. It is further maintained that the stability of a double-stranded RNA would also depend upon a number of factors, such as sequence composition (e.g., GC content), thermodynamic stability and sequence length etc.
Applicant has not taught how one makes or isolates sequences with unspecified changes in the nucleotide sequences that would be used as RNA inhibitory sequences directed to endogenous male fertile gene and endogenous herbicide resistance gene and gene sequences to eliminate their expression in any plant as encompassed by Applicants' broad claims. Applicant has not taught which regions of the respective polynucleotides can be used to amplify any of said polynucleotides or which regions can be used as a probe to isolate any of said polynucleotide sequences. Applicant has not taught how antisense or co-suppression based methods of down-regulating the expression of any endogenous gene sequences from any plant sources, that would produce a useful trait as encompassed by the breadth of the claims.
In the absence of guidance, undue trial and error experimentation would have been required by one skilled in the art at the time the claimed invention was made to screen through the multitude of non-exemplified sequences, either by using non-disclosed fragments of endogenous male fertile gene and endogenous herbicide resistance gene sequences as probes or by designing primers to undisclosed regions of endogenous male fertile gene and endogenous herbicide resistance gene sequences, and isolating or amplifying fragments, subcloning the fragments, producing expression vectors and transforming plants therewith, in order to identify those, if any, that when over-expressed will reduce or eliminate expression or activity of endogenous male fertile gene and endogenous herbicide resistance gene and which results in an improved trait as encompassed by the breadth of the claims.
The claims also encompass down-regulating expression of genetic elements, such as endogenous male fertile gene and endogenous herbicide resistance gene from any plant sources by T-DNA insertion mutagenesis. State of the art related with T-DNA mutagenesis is itself a highly unpredictable technique. For example, Bonawitz et al.,(Annu. Rev. Genet. 44: 337-363, 2010) teach that T-DNA insertional mutants in Arabidopsis with a complete block in the monolignol biosynthetic pathway (enzymes involved in lignin biosynthesis) resulted in the developmental growth arrest at the seedling stage. See in particular, page 353, 2nd paragraph of right column. In the absence of adequate guidance, it would require undue experimentation to practice the claimed invention for the full scope of down-regulating expression of endogenous male fertile gene and endogenous herbicide resistance gene in any plant species as encompassed by the breadth and the scope of the claims.
The breadth of claims also encompasses reducing or eliminating the expression of endogenous male fertile gene and endogenous herbicide resistance gene sequences encoding proteins using genome editing technique (e.g. CRISPR/Cas system).
The state of art related with CRISPR/Cas9 (Paul et al., Plant Cell Reports; 35:1417-1427; 2016) clearly suggests that the efficiency of Cas9 editing among plants depends on plant species, genomic loci targeted, expression levels of gRNA and Cas9, among other factors. The reference further teaches that Cas9:gRNA complexes routinely result off-target binding and cleavages which can result in unwanted mutations and chromosomal abnormalities. See in particular, last four lines of last paragraph of left column on page 1418.
In the absence of adequate guidance, it would require undue experimentation, to design CRISPR/Cas9 system specifically targeting endogenous elements endogenous male fertile gene and endogenous herbicide resistance gene sequences from any plant sources to eliminate or reduce their expression in any plant species as encompassed by the breadth and scope of the claims.
Thus in the absence of adequate guidance from the specification, undue trial and error experimentation would be required to screen through the myriad of nucleic acids encompassed by the claims and plant cells or plants transformed therewith to identify those with improved characteristics as claimed upon reducing or eliminating the expression of genetic elements endogenous male fertile gene and endogenous herbicide resistance gene sequences from any plant sources, as encompassed by the breadth and the scope of the claims.
In the absence of guidance, it would require undue experimentation to isolate, identify, characterize non-plant or plant derived endogenous male fertile gene and endogenous herbicide resistance gene and then use them instantly claimed process as encompassed by the breadth and scope of claims.
Additionally, instantly claimed method encompasses claims encompass practicing instantly claimed method that does not comprise transforming any plant with a multigene construct having elements AR-Xi-Y-Bi-C
The specification, however, fails to provide guidance on how to make and use in the instantly claimed method in any manner other than transforming said plant with a multigene construct having elements AR-Xi-Y-Bi-C. The specification does not provide guidance on co-factors, or regulators of genetic elements of multigene construct having elements AR-Xi-Y-Bi-C, for example that makes the either overexpressing of gene(s) or down-regulating endogenous genes as encompassed by the breadth and scope of claims.
In the absence of guidance, undue experimentation would have been required increase and down-regulate expression of endogenous genes that does not involve plant transformation with appropriate DNA construct directed towards increasing expression of said genetic elements, in any plant species, including rice as encompassed by the breadth of the claims.
Given the breadth of the claims, unpredictability of the art and lack of guidance of the specification, as discussed above, undue experimentation would be required by one skilled in the art to make and use the claimed invention commensurate in scope with the claims.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
5. Claim(s) 1-7 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 106834305 A, pages 1-24, English translation attached with the foreign document, Published March 16, 2017), and Ren et al. (The Plant Journal, 98:315-328, Published December 27, 2018 supplementary documents attached), and further in view of Zhang et al. (CN 102586278 A, pages 1-24, English translation attached with the foreign document, Published March 16, 2017), Wahler et al. (GenBank Sequence Accession NO. KF036176.1, pages 1-2, Published July 2013), Xu et al. (Rice, 7:5, pages 1-4, published 2014, supplementary documents attached) and Zhao et al. (J. Plant Biol., 59:496-505, Published 2016, supplementary documents attached).
Li et al. teach a method for affecting plant fertility by regulating expression of the OsSTRL2 gene, resulting in a rice male sterile line suitable for hybrid seed production. Li et al. further teach restoration of male fertility, provides a sterile mutant sequence of OsSTRL2, and describes male sterile mutant materials that cause male sterility through mutation of the endogenous OsSTRL2 gene. The OsSTRL2 promoter is described as an anther-specific promoter. Li et al. also teach that the construct may include selectable marker genes such as antibiotic or herbicide resistance genes or color marker genes such as anthocyanin. The obtained rice male sterile line is used as a female parent in hybrid breeding.
In addition, Li et al. teach a method for maintaining and propagating the male sterile line using the OsSTRL2 gene or its promoter by transforming three linked genes—a fertility restorer gene, a pollen inactivation gene, and a color marker screening gene—into a homozygous recessive nuclear male sterile mutant. The screening gene is used to distinguish between transgenic and non-transgenic seeds, with the non-transgenic seeds used as sterile lines and the transgenic seeds used as maintainer lines. Li et al. further teaches transformation using standard recombinant vector methods (see paragraphs [0012]–[0035]).
Ren et al. teach OsPTD1 gene is required for normal crossover (CO) formation during rice meiosis. The reference teaches down-regulating expression of endogenous OsPTD1 gene expression using CRISPR-Cas9 system. The OsPTD1 transgenic mutant rice plants exhibited normal vegetative growth and floral development, however the pollen grains of said mutants were aborted. The reference further teaches that segregation analysis confirmed the cosegregation of the sterile phenotype and the mutation. See in particular, last two paragraphs of right column at page 320 through the end of first paragraph at page322, Figures S1e, Figure S1f, Figure 6a, b, j, k) (Figure 6c-e, I, n), Table S5).
Li et al. or Ren et al. do not specifically teach OsABCG15 gene and particular method or procedural method steps for propagating a sporophytic recessive nuclear male sterile line.
Zhang et al. teach that rice is a self-pollinating crop and that the development of male sterile lines is a primary method for exploiting heterosis. Zhang et al. identifies the OsABCG15 gene, involved in anther epidermis and pollen wall lipid deposition, as essential for pollen fertility. The reference further teaches that the deletion of OsABCG15 gene results in male sterility, providing a means of producing new rice male sterile lines. The reference also teaches that mutations in the OsABCG15 gene can cause male sterility and be used to produce rice male sterile lines for hybrid seed production (see paragraphs [0003]–[0006]).
Zhang et al. teach that rice is a self-pollinating crop and that the development of male sterile lines is a primary method for exploiting heterosis. Zhang et al. identifies the OsABCG15 gene, involved in anther epidermis and pollen wall lipid deposition, as essential for pollen fertility. The reference further teaches that the deletion of OsABCG15 gene results in male sterility, providing a means of producing new rice male sterile lines. The reference also teaches that mutations in the OsABCG15 gene can cause male sterility and be used to produce rice male sterile lines for hybrid seed production (see paragraphs [0003]–[0006]).
Wahler et al. teach a plant selectable marker bar gene encoding phosphinothricin-acetyl-transferase providing herbicide resistance to transgenic rice. The bar gene was expressed from CaMV 35S promoter and cloned into a transformation vector. See in particular, pages 1-2.
Xu et al. teach that rice genome carries endogenous Bentazon Sensitive Lethal (BEL, LOC_Os03g0760200) gene which confers resistance to bentazon and sulfonylurea herbicides, and the loss-of-function mutant bel is sensitive to the herbicides.
Applicant’s attention is drawn to Xu et al teachings under “Findings” on page 1 which states:
“Findings Here, we report gene targeting in rice via the Agrobacterium tumefaciens-mediated CRISPR-Cas9 system. Three 20-nt CRISPR RNAs were designed to pair with diverse sites followed by the protospacer adjacent motif (PAM) of the rice herbicide resistance gene BEL. After integrating the single-guide RNA (sgRNA) and Cas9 cassette in a single binary vector, transgenic rice plants harboring sgRNA:Cas9 were generated by A. tumefaciens-mediated stable transformation. By analyzing the targeting site on the genome of corresponding transgenic plants, the mutations were determined. The mutagenesis efficiency was varied from ~2% to ~16%. Furthermore, phenotypic analysis revealed that the biallelic mutated transgenic plant was sensitive to bentazon.”
Applicant’s attention is drawn to Xu et al teachings at page 2, 2nd paragraph lines 3-9, which states:
“The rice Bentazon Sensitive Lethal (BEL, LOC_Os03g0760200) gene confers resistance to bentazon and sulfonylurea herbicides. The loss-of-function mutant bel is sensitive to the herbicides (Pan et al. [2006]). In two-line hybrid rice production, when male sterile lines are developed in the bel background, the problem of hybrid seed contamination by the selfing of sterile lines can be solved by simply spraying bentazon at the seedling stage. Although BEL has the potential to improve hybrid rice production safety, the limited natural genetic resources greatly restrict its application. Therefore, we selected BEL gene as the target for sgRNA:Cas9-based disruption.”
In summary, Xu et al. teach that by down-regulation of endogenous Bel gene in rice, it helps in producing contamination free sterile lines of rice by improving purity using herbicides, such as bentazon, and these pure sterile lines of rice are used in a rice breeding program to improve yield and safety of hybrid seed. See in particular, abstract, Figures 1a, 1b; and attached supplementary Figures S1-S3 and Table S1, pages 1-4 and supplementary pages attached at the end of the reference.
Zhao et al. teach that OsC gene (LOC_Os06g10350) in rice encodes a R2R3MYB transcription factor (same as OsMYB76R) and acts as color producing gene. The reference further teaches transgenic overexpression of OsC gene under its native promoter into Oryza japonica cv. Kitaake carrying colorless apiculus and stigma resulted in transformed plant(s) exhibiting red apiculi at near -maturity stage. The apiculus color gradually deepened from the 10th day post-heading. See in particular, abstract, Figures 1-6; pages 499-501; Table 1, results, discussion and materials and methods at pages 497-503.
Given (i) Li et al. teach generating and maintaining rice nuclear male-sterile lines by modifying endogenous fertility-related genes (e.g., OsSTRL2) and introducing linked multigene constructs comprising a fertility restorer, a pollen-inactivation cassette, and selectable markers—including herbicide- or antibiotic-resistance genes; (ii) substituting one known male-fertility gene (such as OsSTRL2) with another known male-fertility gene (such as the OsPTD1 gene of Ren et al.) constitutes a predictable variation yielding the same functional outcome of nuclear male sterility upon loss-of-function; and (iii) Zhang et al. teach that mutations in OsABCG15 cause complete male sterility and facilitate production of sporophytic recessive nuclear male-sterile lines for hybrid seed production, it would have been obvious and well within the skill of an ordinary artisan, prior to the earliest effective filing date, to apply similar fertility-related genes and promoters in the Li et al. system by substituting the OsPTD1 gene of Ren et al. to obtain male sterility. The teachings of Li et al. and Zhang et al. are directly aligned in purpose—breeding and producing sporophytic or nuclear male-sterile lines—and thus provide explicit motivation to combine.
Furthermore, because Li et al. provide detailed and enabling guidance concerning the underlying genetic framework and linked multigene constructs, and because such substitutions represent nothing more than predictable modifications yielding the same outcome (i.e., production, maintenance, and propagation of rice male-sterile lines), it would have been obvious to one of ordinary skill in the art, prior to the earliest filing date, to apply Li et al.’s methods—together with routine optimization of transformation parameters or fertility-gene selection—to achieve propagation of a sporophytic recessive nuclear male-sterile line and arrive at the claimed methods with a reasonable expectation of success and without any unexpected results.
Accordingly, it also would have been obvious to substitute or combine fertility-related genes such as OsSTRL2, OsPTD1, and OsABCG15, or to employ equivalent marker systems or restorer constructs, since these are well-characterized components routinely used to achieve sterility, restoration, or selection in rice transformation and hybrid seed production. A POSITA would have viewed these substitutions as straightforward, predictable choices yielding no surprising results.
As detailed above: (i) Li et al. disclose a sterile mutant defective in an endogenous sporophytic male-fertility gene (OsSTRL2) and introduction of a linked multigene construct containing a fertility gene, a pollen-inactivation element, and marker genes—including herbicide-resistance and anthocyanin color markers (paragraphs 0012–0035)—and further teach use of this system for distinguishing transgenic from non-transgenic seeds, generating male-sterile and maintainer lines, and enabling segregation, selfing, and propagation of such lines for hybrid seed production; (ii) Ren et al. teach that OsPTD1 is an essential gametophytic male-fertility gene required for meiotic crossover formation, and that down-regulation or CRISPR-mediated mutation of OsPTD1 results in pollen abortion while maintaining normal plant growth, with clear cosegregation of gene disruption and sterility (pp. 320–322; Fig. 6; Supp. Figs. S1, S5), thereby teaching the very type of gametophytic male-fertility “down-regulation element” (Xi) recited in the claims; (iii) Zhang et al. identify OsABCG15 as an essential sporophytic male-fertility gene required for pollen wall and anther epidermis formation, where loss-of-function produces complete male sterility useful for recessive nuclear male-sterile line development (paragraphs 0003–0006), thus teaching the identical type of gene Y recited in the claims; (iv) Wahler et al. teach that the bar gene confers phosphinothricin (Basta) resistance under a CaMV 35S promoter, establishing its routine use as a selectable herbicide-resistance marker in rice transformation; (v) Xu et al. teach that the endogenous BEL gene confers resistance to bentazon and sulfonylureas, and that CRISPR-mediated knockdown produces herbicide sensitivity (pages 1–4; Supp. Figs. S1–S3), enabling herbicide-based purification of sterile lines in hybrid seed production and teaching the precise herbicide-B-related down-regulation element (Bi) and bentazon purification method recited in the claims; and (vi) Zhao et al. teach that OsC (OsMYB76R) is an anthocyanin gene conferring visible coloration, where overexpression yields red apiculus or stigma pigmentation, thus supplying the anthocyanin color-marker system (C) recited in the claims.
Given this fully integrated framework, a POSITA would have found it obvious to arrive at the claimed methods. Li et al. provide an explicit, complete, enabling architecture for multigene constructs used to maintain recessive nuclear male sterility. Each secondary reference merely supplies a known gene performing the same function already contemplated in Li et al.’s framework. The substitution of one known species for another within an established functional category is precisely the type of predictable variation described in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). The cited art discloses a finite and well-defined set of options for each gene category (fertility gene, interference cassette, herbicide marker, down-regulation element, color marker). A POSITA would have reasonably expected success in combining these elements (KSR, 550 U.S. at 421), and the record lacks any evidence of unexpected results. All recited outcomes—male sterility, herbicide-based selection, color-based segregation, and maintainer-line propagation—are explicitly taught and predictable in view of Li et al. and the secondary references.
The claims employ only routine cloning, transformation, and breeding techniques that were well-established at the time, as confirmed by the cited art. Accordingly, claims 1–7 and 9–14 are rejected as prima facie obvious. The claimed subject matter constitutes no more than routine optimization of the Li et al. system using known gene components performing their conventional functions. Substitution of known species within known functional categories is a textbook design choice and is prima facie obvious under MPEP § 2144.04. Furthermore, (a) Ren et al., Zhang et al., Wahler et al., Xu et al., and Zhao et al. merely supply interchangeable species for the generic elements disclosed in Li et al.; (b) employing two herbicide systems for line segregation is a predictable extension of Li et al.’s and the secondary references’ screening strategies; (c) integrating color and herbicide markers is expressly suggested in the cited art; and (d) replacing Li et al.’s generic markers with Bar or OsMYB76R is an obvious choice based on their known properties. For these reasons, the claimed methods would have been readily achieved by a POSITA prior to earliest filing date of the instantly claim invention, and yield only predictable results.
It may be noted that claim 4 is included in this rejection because of the following reasons: Breadth of claim 4 reads on any sequence because recitations (see underlined) of phrases “a nucleotide sequence of the Bar gene is shown in SEQ ID NO. 6” “a sequence of the down-regulation element Bi of the herbicide B resistance gene is shown in SEQ ID NO. 18; “a nucleotide sequence of the OsABCG15 gene is shown in SEQ ID NO. 17”; non-specific “ interference sequence of the gametophyte male sterility-related gene OsPTD1 gene is shown in SEQ ID NO. 20”; and “a nucleotide sequence of the pigment expression related gene OsMYB76R gene is shown in SEQ ID NO. 11. It may be noted recitations “a nucleotide sequence” or “a sequence” reads on any sequence having just 2 nucleotide sequence of SEQ ID NOs recited in the claim 4.
Conclusion
6. Claims 1-7 and 9-14 are rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. Abraham can be reached on (571) 270-7058 The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VINOD KUMAR/Primary Examiner, Art Unit 1663
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