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 .
Priority
Acknowledgment is made of applicant’s claim for benefit under 35 U.S.C. 119(e).
Status of the Claims
Claims 1-5, 8-14, 17-24 are pending.
Claims 1-5, 8-14, 17-24 are examined herein.
Claim Objections
Claim 13 is objected to as being dependent upon a rejected claim, but would be allowable if amended to include all of the limitations of the claims from which it depends.
Specification
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8-10, 12, 18-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinebrunner, Iris, et al. "Disruption of apyrases inhibits pollen germination in Arabidopsis." Plant Physiology 131.4 (2003): 1638-1647.
Applicant claims a recombinant plant, wherein the plant has been engineered to contain at least one modified apyrase gene and at least one additional apyrase gene (Claim 1), the recombinant plant of claim 1, wherein the plant exhibits at least one improved agronomic trait relative to a plant not comprising the modified apyrase gene and/or the at least one additional apyrase gene; wherein the improved agronomic trait is selected from the group consisting of: increased yield, phosphate uptake, drought resistance, disease resistance, fungal resistance, nutrient uptake, water uptake, average primary root length, average number of lateral roots, average number of seed pods, average seed pod size, average seed size, average seed weight, seed germination, seed survival, average number of siliques, average silique size, average leaf area, average leaf length, and average plant height (Claim 2), the modified plant of claim 1, wherein the plant is a monocot plant or a dicot plant (Claim 3), the recombinant plant of claim 1, wherein the additional apyrase gene is a naturally occurring apyrase gene (Claim 8), the recombinant plant of claim 1, wherein the additional apyrase gene is an exogenous apyrase gene (Claim 9), the recombinant plant of claim 1, wherein the additional apyrase gene is inserted into the genome of the modified plant (Claim 10), the recombinant plant of claim 1, wherein the additional apyrase gene is a pea apyrase gene or an Arabidopsis apyrase gene (Claim 12), a progeny plant of the recombinant plant of claim 1 (Claim 17), a seed of the recombinant plant of claim 1 (Claim 18), a plant part of the recombinant plant of claim 1 (Claim 19), the plant part of claim 19, wherein the plant part is a cell, a seed, a root, a stem, a leaf, a head, a flower, or pollen (Claim 20), a method of producing a recombinant plant, comprising modifying the genome of the plant by adding or engineering at least one modified apyrase gene and at least one additional apyrase gene (Claim 21), the method of claim 21, wherein at least one of the modified apyrase gene and the additional apyrase gene is added via Agrobacterium transformation (Claim 22), the method of claim 21, wherein the modified apyrase gene and an additional apyrase gene are added via Agrobacterium transformation (Claim 23).
Steinebrunner discloses single and double-mutants (non-viable) of Arabidopsis thaliana AtAPY1 and AtAPY2 apyrase genes. Steinebrunner discloses that the mutants were generated by T-DNA insertion knockouts (genetic modifications of the apyrase genes) (p. 1639 left col. ¶ 3 – right col. ¶ 1, Figure 1). Steinebrunner discloses that the double mutants were non-viable. Steinebrunner discloses that double heterozygotes were transformed by Agrobacterium-mediated transformation with wild-type AtAPY1 and AtAPY2 cDNA, respectively, to rescue the phenotype. (p. 1643 left col. ¶ 3 – right col. ¶ 1). Progeny, seeds and plant parts are deemed inherent to the rescued progeny plants comprising the modified AtAPY1 and AtAPY2 apyrase genes and additional wild-type exogenous AtAPY1 and AtAPY2 cDNA expression constructs. The rescued plants, being viable, exhibit improvement in all of the traits listed in Claim 2 relative to a plant not comprising the at least one additional apyrase genes.
As such the claims are anticipated by the prior art.
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 1, 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Steinebrunner, Iris, et al. "Disruption of apyrases inhibits pollen germination in Arabidopsis." Plant Physiology 131.4 (2003): 1638-1647 in view of Windsor et al. (US 20020160915 A1) taken with evidence of UniProt Accession P52914, entered 01/10/1996 and the instant Specification.
Applicant claims a recombinant plant, wherein the plant has been engineered to contain at least one modified apyrase gene and at least one additional apyrase gene (Claim 1), the modified plant of claim 1, wherein the plant is a monocot plant or a dicot plant (Claim 3), the recombinant plant of claim 3, wherein the plant is a soybean, cotton, canola, potato, rice, wheat, sugar beet, or corn plant (Claim 4), the modified plant of claim 1, wherein the modified apyrase gene is a modified psNTP9 (Claim 5), the recombinant plant of claim 1, wherein the additional apyrase gene encodes the amino acid sequence of SEQ ID NO: 1 (Claim 14), a method of producing a recombinant plant, comprising modifying the genome of the plant by adding or engineering at least one modified apyrase gene and at least one additional apyrase gene (Claim 21), the method of claim 21, wherein the recombinant plant is produced by crossing a plant comprising a modified apyrase gene and a plant comprising an additional apyrase gene (Claim 24).
Steinebrunner teaches single and double-mutants (non-viable) of Arabidopsis thaliana AtAPY1 and AtAPY2 apyrase genes. Steinebrunner teaches that the mutants were generated by T-DNA insertion knockouts (genetic modifications of the apyrase genes) (p. 1639 left col. ¶ 3 – right col. ¶ 1, Figure 1). Steinebrunner teaches that the double mutants were non-viable. Steinebrunner teaches that double heterozygotes were transformed by Agrobacterium-mediated transformation with wild-type AtAPY1 and AtAPY2 cDNA, respectively, to rescue the phenotype. (p. 1643 left col. ¶ 3 – right col. ¶ 1). Progeny, seeds and plant parts are deemed inherent to the rescued progeny plants comprising the modified AtAPY1 and AtAPY2 apyrase genes and additional wild-type exogenous AtAPY1 and AtAPY2 cDNA expression constructs. The rescued plants, being viable, exhibit improvement in all of the traits listed in Claim 2 relative to a plant not comprising the at least one additional apyrase genes. Steinebrunner teaches that earlier studies showed that the overexpression of pea apyrase (GenBank accession no. P52914) in Arabidopsis conferred significantly enhanced growth in phosphate rich environments. (p. 1640 left col. ¶ 2).
Windsor teaches an Arabidopsis thaliana plant wherein the plant over-expresses an MDR-ABC transporter and an ecto-phosphatase wherein the ecto-phosphatase that is over-expressed is an exogenous Pisum sativum apyrase psNTP9 under the control of a 35S CaMV promoter, and progeny of the plants. Windsor teaches that the plants were transformed via Agrobacterium mediated transformation with a recombinant DNA molecule comprising the apyrase psNTP9 coding sequence operably linked to a heterologous 35S CaMV. (¶ 100). Seeds and plant parts are deemed to be inherent to the plants that produce progeny. Windsor teaches that the plants overexpressing apyrase exhibited increased germination rates. (¶ 0025, Figure 6). Windsor teaches that the manipulation of extracellular ATP levels and hence the ATP gradient across biological membranes in plant cells by the over-expression of a MDR-ABC transporter and an ecto-phosphatase, results in resistance to certain plant hormones, drugs and herbicides. Such resistance is useful in horticulture of recombinant crops for the elimination of other unwanted plants (e.g. weeds) which are not resistant. (¶ 0042). Windsor teaches that the plants that can be used in the invention include crops and soybean, cotton, canola, potato, rice, wheat, and corn are all major crop plants. (¶ 0053).
UniProt Accession P52914, entered 01/10/1996, provides evidence that the sequence of the apyrase of Windsor et al. shares 100% identity to the instant SEQ ID NO:1. An alignment of UniProt Accession P52914 and the instant SEQ ID NO:1 is as follows:
Query Match 100.0%; Score 2363; DB 1; Length 455;
Best Local Similarity 100.0%;
Matches 455; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MELLIKLITFLLFSMPAITSSQYLGNNLLTSRKIFLKQEEISSYAVVFDAGSTGSRIHVY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MELLIKLITFLLFSMPAITSSQYLGNNLLTSRKIFLKQEEISSYAVVFDAGSTGSRIHVY 60
Qy 61 HFNQNLDLLHIGKGVEYYNKITPGLSSYANNPEQAAKSLIPLLEQAEDVVPDDLQPKTPV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 HFNQNLDLLHIGKGVEYYNKITPGLSSYANNPEQAAKSLIPLLEQAEDVVPDDLQPKTPV 120
Qy 121 RLGATAGLRLLNGDASEKILQSVRDMLSNRSTFNVQPDAVSIIDGTQEGSYLWVTVNYAL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 RLGATAGLRLLNGDASEKILQSVRDMLSNRSTFNVQPDAVSIIDGTQEGSYLWVTVNYAL 180
Qy 181 GNLGKKYTKTVGVIDLGGGSVQMAYAVSKKTAKNAPKVADGDDPYIKKVVLKGIPYDLYV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GNLGKKYTKTVGVIDLGGGSVQMAYAVSKKTAKNAPKVADGDDPYIKKVVLKGIPYDLYV 240
Qy 241 HSYLHFGREASRAEILKLTPRSPNPCLLAGFNGIYTYSGEEFKATAYTSGANFNKCKNTI 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 HSYLHFGREASRAEILKLTPRSPNPCLLAGFNGIYTYSGEEFKATAYTSGANFNKCKNTI 300
Qy 301 RKALKLNYPCPYQNCTFGGIWNGGGGNGQKNLFASSSFFYLPEDTGMVDASTPNFILRPV 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 RKALKLNYPCPYQNCTFGGIWNGGGGNGQKNLFASSSFFYLPEDTGMVDASTPNFILRPV 360
Qy 361 DIETKAKEACALNFEDAKSTYPFLDKKNVASYVCMDLIYQYVLLVDGFGLDPLQKITSGK 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 DIETKAKEACALNFEDAKSTYPFLDKKNVASYVCMDLIYQYVLLVDGFGLDPLQKITSGK 420
Qy 421 EIEYQDAIVEAAWPLGNAVEAISALPKFERLMYFV 455
|||||||||||||||||||||||||||||||||||
Db 421 EIEYQDAIVEAAWPLGNAVEAISALPKFERLMYFV 455
It would have been prima facie obvious at the time of filing to modify the method and plants of Steinebrunner such that the plants are made to comprise additional apyrase genes that were known in the art, such as psNTP9 from pea as taught by Windsor. One having ordinary skill in the art would have been motivated to do so because Windsor teaches that the pea apyrase can function in Arabidopsis plants and that plants overexpressing said apyrase exhibited superior growth. One would have a reasonable expectation of success because Windsor teaches that the apyrase was functional in Arabidopsis.
It would have been prima facie obvious at the time of filing to modify the method and plants of Steinebrunner are crop plants as taught by Windsor. Indeed it would have been obvious to create plants such as soybean or canola comprising multiple exogenous apyrase genes, wherein the genes are modified by making them cDNAs as taught by Steinebrunner. One having ordinary skill in the art would have been motivated to do so because Steinebrunner teaches that overexpressing apyrase genes in plants can cause significant increases in growth, a useful agronomic phenotype. One of ordinary skill in art would have had a reasonable expectation of success because Steinebrunner teaches that overexpression increases growth and it would be reasonable to use modified genes as taught by Steinebrunner because of their smaller size which is convenient for cloning.
It would have been further obvious to construct said plants by introducing modified apyrase genes via crossing as taught by Steinebrunner. Introducing transgenes via crossing was a known functional equivalent of direct Agrobacterium-mediated transformation. As such, it would have been prima facie obvious to make plants comprising multiple extra modified apyrase genes by crossing said genes into the plants.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Steinebrunner, Iris, et al. "Disruption of apyrases inhibits pollen germination in Arabidopsis." Plant Physiology 131.4 (2003): 1638-1647 in view of Windsor et al. (US 20020160915 A1) and Timmermans et al. "Geminiviruses and their uses as extrachromosomal replicons." Annual review of plant biology 45.1 (1994): 79-112.
Applicant claims a recombinant plant, wherein the plant has been engineered to contain at least one modified apyrase gene, and/or at least one additional apyrase gene (Claim 1), the recombinant plant of claim 1, wherein the additional apyrase gene is expressed extrachromosomally.
The teachings of Steinebrunner and Windsor as they are applied to Claim 1 are set forth previously herein and are incorporated by reference.
Neither Steinebrunner nor Windsor teach extrachromosomal expression of the additional apyrase.
Timmermans teaches using geminiviruses as extrachromosomal expression vectors. Timmermans teaches that the advantages of using geminivirus expression systems include high expression as a result of high copy number of the vectors in plant systems. (p. 104 ¶ 1).
It would have been prima facie obvious at the time of filing to modify the methods and plants rendered obvious by Steinebrunner and Windsor such that the apyrase is expressed from an extrachromosomal vector such as a geminivirus as taught by Timmermmans. One having ordinary skill in the art would have been motivated to do so because Timmermnans teaches that geminiviruses are functional equivalents to expression from Agrobacterium-mediated transformation insofar as both expression technologies allow for expression of heterologous genes in plants, and substituting known equivalents for the same purpose is prima facie obvious. Further Timmermnans teaches additional advantages including high expression levels. As such the claims are obvious in view of the teachings of the art.
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 1-5, 8-12, 14, 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11203745 in view of Steinebrunner, Iris, et al. "Disruption of apyrases inhibits pollen germination in Arabidopsis." Plant Physiology 131.4 (2003): 1638-1647 and Windsor et al. (US 20020160915 A1) and Timmermans et al. "Geminiviruses and their uses as extrachromosomal replicons." Annual review of plant biology 45.1 (1994): 79-112
11203745 claims as follows:
1. A recombinant plant, wherein the plant has been engineered to contain at least one modified apyrase gene, wherein the modified apyrase gene is a modified psNTP9, encodes a polypeptide comprising the amino acid sequence of SEQ ID NO:2, or comprises a DNA sequence comprising SEQ ID NO:4.
2. The recombinant plant of claim 1, wherein the plant comprises apyrase genes that express the amino acid sequences of SEQ ID NO:1 and SEQ ID NO:2.
3. A progeny plant of the recombinant plant of claim 1, wherein the progeny plant comprises the at least one modified apyrase gene.
4. A seed of the recombinant plant of claim 1, wherein the seed comprises the at least one modified apyrase gene.
5. A plant part of the recombinant plant of claim 1, wherein the plant part comprises the at least one modified apyrase gene.
6. A method of producing a modified plant, comprising modifying the genome of the plant by adding or engineering at least one modified apyrase gene, wherein the modified apyrase gene is a modified psNTP9, encodes a polypeptide comprising the amino acid sequence of SEQ ID NO:2, or comprises a DNA sequence comprising SEQ ID NO:4.
7. The method of claim 6, wherein at least one of the modified apyrase gene is added via Agrobacterium transformation.
8. The method of claim 6, further defined as comprising: a) placing the modified plant, or a progeny thereof that comprises the at least one modified apyrase gene, under drought or osmotic stress; and b) identifying an improved agronomic trait in the modified plant or the progeny plant; wherein the plant exhibits at least one improved agronomic trait relative to an otherwise isogenic plant line from which it was derived, the otherwise isogenic line not comprising the modified apyrase gene, and wherein the improved agronomic trait is selected from the group consisting of: increased yield, phosphate uptake, drought resistance, disease resistance, fungal resistance, nutrient uptake, water uptake, average primary root length, average number of lateral roots, average number of seed pods, average seed pod size, average seed size, average seed weight, seed germination, seed survival, average number of siliques, average silique size, average leaf area, average leaf length, and average plant height.
9. The recombinant plant of claim 1, wherein the plant exhibits at least one improved agronomic trait relative to a plant not comprising the at least one modified apyrase gene; wherein the improved agronomic trait is selected from the group consisting of: increased yield, phosphate uptake, drought resistance, disease resistance, fungal resistance, nutrient uptake, water uptake, average primary root length, average number of lateral roots, average number of seed pods, average seed pod size, average seed size, average seed weight, seed germination, seed survival, average number of siliques, average silique size, average leaf area, average leaf length, and average plant height.
11203745 does not claim that the plants comprise additional apyrase genes, that the plants are crop plants including soybean, that the additional or modified genes are introduced through crossing or that the additional genes are expressed extra-chromosomally. The rationales for modifying the methods and plants of claims of 11203745 to comprise additional apyrase genes, use crop plants including soybean, introduce the genes through crossing and express the extra genes extra-chromosomally are set forth previously herein in the 103 rejections. The limitations of the claims of 11203745, reciting pea apyrases having specific sequence identifiers, are species to the generic recitations of apyrases in the instant claims. Because the instant claims are directed to a genus of the species claimed in 11203745, those limitations are prima facie obvious.
Conclusion
No claims are allowed.
Claim 13 appears to be free of the prior art. The closest prior art is Steinebrunner, Iris, et al. "Disruption of apyrases inhibits pollen germination in Arabidopsis." Plant Physiology 131.4 (2003): 1638-1647. However, neither Steinebrunner nor the prior art disclose, teach or otherwise render obvious the sequence of SEQ ID NO:3.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES A LOGSDON whose telephone number is (571)270-0282. The examiner can normally be reached M-F 8:30 - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo (Joe) Zhou can be reached on (571)272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES LOGSDON/Primary Examiner, Art Unit 1662
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