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 of Group I (claims 1, 2, 7, 8-26 (part) and 30) in the reply filed on March 9, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-31 are pending. Claims 3-6, 27-29 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
It is important to note that any claim directed to “heterologous protein comprises genome editing reagent” would be considered as non-elected subject matter. Elected subject matter must recite a heterologous polynucleotide encoding a genome editing agent or a non-coding RNA of interest.
Accordingly claims 1, 2, 7, 8-26 and 30 in conjunction with contacting the wounded axillary meristem region with a heterologous polynucleotide 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 corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing 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 April 28, 2022, December 18, 2023 and March 18, 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.
The listing of references in the specification (see page 46) 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.
Specification
3. The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See for example, page 46, line 24. 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.
Appropriate correction is required.
Claim Objections
4. Claims 1, 11, 12, 15, 17, 18, 19, 20, 24, 25 and 26 are objected to because of the following informalities:
Claims 1, 19 and 20 are objected for having non-elected subject matter. Non-elected subject matter is where heterologous protein is directly required to practice the method. It is important to note that the elected invention is a heterologous polynucleotide encoding a heterologous protein or non-coding RNA of interest is required.
In claims 11, 12: the recitation “the corresponding area of the plant” appears to lack proper antecedent basis. Claim 12 is also included because it is dependent on claim 11 which fails to overcome this deficiency. Appropriate claim amendments must be made for the clarity of the subject matter.
In Claim 12, it is suggested to change the recitation “, optionally” in line 5 to ---or--- for clarity of claimed subject matter.
In Claim 15, it is suggested to change the recitation “, optionally” in line 3 to ---or--- for clarity of claimed subject matter.
In Claim 17, it is suggested to delete the recitation “optionally” in line 3, otherwise, claim 17 would read on a wild-type seed which is untransformed. That does not appear to be Applicant’s intention.
In Claim 19, it is suggested to change the recitation “, optionally” in line 3 to ---or--- for clarity of claimed subject matter.
In Claim 18, it is suggested to delete the recitation “optionally” in line 2, otherwise, claim 17 would read on a wild-type progeny which is untransformed. That does not appear to be Applicant’s intention.
In claims 19 and 20, the recitation “optionally” should be change to ---or--- as long as the claims are directed only to the elected subject matter. As stated above that the elected invention is a heterologous polynucleotide encoding a heterologous protein or non-coding RNA of interest is required. The non-elected subject matter includes “or wherein the heterologous protein comprises a Cas protein, optionally wherein the Cas protein is Cas9 or Cas12a, or a functional variant thereof.” The non-elected subject matter needs to be deleted.
In claim 24, the recitation “electroporation or pressure” in line 3 should be change to ---or electroporation---. The recitation “pressure” does not make any technical sense as it is misleading which pressure Applicant is referring to?
In Claim 25, it is suggested to change the recitation “, and optionally” in line 2 to ---or wherein the method further comprises-- for clarity of claimed subject matter.
In Claim 26, it is suggested to change the recitation “optionally 4-5 days” to ---or 4 to 5 days--- for the clarity of the claimed subject matter.
Appropriate correction and/or clarifications 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.
5. Claims 18, 20, 22, 25 and 26 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 18, 20, 22, 25 and 26 are rejected under 35 U.S.C. 112(b), as being indefinite for being
dependent on itself. As claims 18, 20, 22, 25 and 26 depend upon itself, the scope of claims 18, 20, 22, 25 and 26 cannot be determined. See MPEP 2260.01 Dependent Claims [R-07.2015].
Applicant may amend the claim(s) to place the claim(s) in proper dependent form.
Claim Rejections - 35 USC § 102
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.
6. Claim(s) 1, 2, 8-12, 15-18, 21, 22, 23, 24, 25, 26 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schultheiss et al. (US Patent Publication NO. 2015/0074842 A1; Published March 12, 2015).
Schultheiss et al. disclose a method of Agrobacterium mediated transformation of a plant (e.g. soybean) with a recombinant vector comprising a recombinant DNA construct which comprises a heterologous promoter operably linked to a heterologous polynucleotide comprising a coding sequence and wherein said coding sequence is encoding a protein of interest (e.g. hydrophobin protein) to produce resistance against fungal pathogens, and wherein the vector further carries a polynucleotide sequence encoding selection marker (such as AHAS, bar or dsdA genes), the method comprising steps of : a) providing a plant comprising an axillary meristem and a shoot apical meristem, b) removing or wounding (encompasses cutting) at least part of the axillary meristem to produce a wounded axillary meristem region, c) contacting the wounded axillary meristem region with recombinant DNA construct comprising said polynucleotide and/or with Agrobacterium solution carrying said recombinant plasmid having said heterologous polynucleotide under conditions where the heterologous polynucleotide enters wounded axillary meristem region, d) removing the shoot apical meristem or suppressing the growth of the shoot apical meristem to produce a wounded explant, e) culturing the wounded explant in a medium in vitro to promote cell proliferation and regeneration, and f) growing the wounded explant in a proper medium and applying selection agent to the resulting plant in planta to select for a transgenic shoot, and wherein the method comprises removing or suppressing the shoot apical meristem at the same time as step b). The reference also discloses that said method produces a chimeric plant with at least one transgenic shoot. The reference further discloses selecting transformed tissues by exposing them to selection marker which are encoded by plant expressible genes co-transferred with the gene of interest, following which the transformed material is regenerated into a whole plant. The reference also discloses that infected explants are placed on shoot induction medium with selection agents such as glufosinate (a herbicide). The infected epicotyl explants were then placed on a shoot induction medium with selection agents such as imazapyr (for AHAS gene), glufosinate (for bar gene, herbicide resistance), or D-serine (for dsdA gene). The regenerated shoots were subcultured on elongation medium with the selective agent. The reference clearly discloses contacting plant with said selection agent to eliminate or reduce untransformed tissue and wherein the selection agent occurs during or after instant step e) which involves growing the transformed plant to regenerate at least part of the wounded axillary meristem region to produce a regenerated transformed axillary meristem or shoot. The reference further discloses contacting with selection agent comprises adding the selection agent to a medium in which the transformed plant is growing and untransformed plant is unable to grow. Alternatively, the selection agent is applied to wounded axillary meristem regions and/or regenerated axillary meristem. The transformed tissue explants were placed on said selection agent to at least 2-3 weeks. The reference further discloses performing an assay on the transformed tissues, regenerated axillary meristems or a sample of the regenerated axillary meristem to assess for the presence or absence of the transformed cells and the number thereof. The reference further discloses assaying the transformed plants for disease resistance, wherein presence and expression of the transgene was confirmed due to resistance to fungal pathogen(s). The reference also discloses that following DNA transfer and regeneration, putatively transformed plants may also be evaluated, for instance using Southern analysis, for the presence of the gene of interest, and copy number The reference further discloses that expression levels of the newly introduced DNA may be monitored using Northern and/or Western analysis. The reference further discloses obtaining transgenic seeds and raising transgenic progenies from regenerated transformed plants, and wherein the transgenic seeds and raising transgenic progenies comprise the transgene of the transformation event. The reference also discloses that infection with said Agrobacterium solution comprises an infection step and an incubation step. The reference further discloses that said infection step is performed for at least 30 to 60 minutes, and the incubation step is for at least 3 to 5 days in dark. The reference further discloses that said transformed plant is derived from 4 to 8 day seedling explants. The reference further discloses that said axillary meristem is a cotyledonary axillary bud and wherein the method also comprises removing cotyledon of the plant prior to removing or suppressing the shoot apical meristem. The reference also discloses that seedling explants were prepared from plantlets by cutting 0.5 to 1.0 cm below the axillary node on the internode and removing the petiole and leaf from the explant. The reference also discloses that infected epicotyl explants were placed on a shoot induction medium with selection agents such as imazapyr for AHAS gene glufosinate for bar gene or D-serine for dsdA gene, after 2 to 4 weeks the explants were transferred to shoot elongation medium containing a selection compound, spraying the plant with the selection agent, or applying the selection agent to the wounded area of the explant or the corresponding area of the plant, or a combination thereof. The reference further discloses that the infected epicotyl explants were placed on a shoot induction medium with selection agents such as imazapyr for AHAS gene glufosinate for bar gene or D-serine for dsdA gene, after 2 to 4 weeks the explants were transferred to shoot elongation medium containing a selection compound, spraying the plant with the selection agent, or applying the selection agent to the wounded area of the explant or the corresponding area of the plant, optionally wherein it occurs for up to 4 weeks, occurs for up to 2 weeks and up to 5 weeks. It may be noted the claim 30 reads on Schultheib et al. teachings because seedling explants are derived from seed. See for example, paragraphs [0451], [0552], [0074], [0457], [0543], [0447], [0449], [0543], [0445], [0549], [0535], [0551], [0449], [0538], [0550] and [0543]. Also see in particular, abstract, paragraphs [0074], [0457], [0543], [0445], [0447], [0450], [0451], [0505], [0542], [0543], [0549], [0535], [0549], [0551], [0531], [0545], [0535]; and examples 1-8, paragraphs [0522- 0570].
Accordingly, Schultheiss et al. anticipated the claimed invention.
7. Claim(s) 1, 2, 8-12, 15-18, 21, 22, 23, 24, 25, 26 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schultheib et al. (WIPO, WO 2013/093738 A1, Published June 27, 2013).
Schultheib et al. disclose a method of Agrobacterium mediated transformation of a plant (e.g. soybean, Arabidopsis, dicots) with a recombinant vector comprising a recombinant DNA construct which comprises a heterologous promoter operably linked to a heterologous polynucleotide comprising a coding sequence and wherein said coding sequence is encoding a protein of interest (e.g. CL protein) imparting rust resistance to Arabidopsis and soybean, and wherein the vector further carries a polynucleotide sequence encoding selection marker (such as bar gene), the method comprising steps of: a) providing a plant comprising an axillary meristem and a shoot apical meristem, b) removing or wounding (encompasses cutting) at least part of the axillary meristem to produce a wounded axillary meristem region, c) contacting the wounded axillary meristem region with recombinant DNA construct comprising said polynucleotide and/or with Agrobacterium solution carrying said recombinant plasmid having said heterologous polynucleotide under conditions where the heterologous polynucleotide enters wounded axillary meristem region, d) removing the shoot apical meristem or suppressing the growth of the shoot apical meristem to produce a wounded explant, e) culturing the wounded explant in a medium in vitro to promote cell proliferation and regeneration, and f) growing the wounded explant in a proper medium and applying selection agent to the resulting plant in planta to select for a transgenic shoot, and wherein the method comprises removing or suppressing the shoot apical meristem at the same time as step b). The reference also discloses that said method produces a chimeric plant with at least one transgenic shoot. The reference further discloses selecting transformed tissues by exposing them to selection marker which are encoded by plant expressible genes co-transferred with the gene of interest, following which the transformed material is regenerated into a whole plant. The reference also discloses that infected explants are placed on shoot induction medium with selection agents such as glufosinate (a herbicide). The infected epicotyl explants were then placed on a shoot induction medium with selection agents such as imazapyr (for AHAS gene), glufosinate (for bar gene, herbicide resistance), or D-serine (for dsdA gene). The regenerated shoots were subcultured on elongation medium with the selective agent. The reference clearly discloses contacting plant with said selection agent to eliminate or reduce untransformed tissue and wherein the selection agent occurs during or after instant step e) which involves growing the transformed plant to regenerate at least part of the wounded axillary meristem region to produce a regenerated transformed axillary meristem or shoot. The reference further discloses contacting with selection agent comprises adding the selection agent to a medium in which the transformed plant is growing and untransformed plant is unable to grow. Alternatively, the selection agent is applied to wounded axillary meristem regions and/or regenerated axillary meristem. The transformed tissue explants were placed on said selection agent to at least 2-3 weeks. The reference further discloses performing an assay on the transformed tissues, regenerated axillary meristems or a sample of the regenerated axillary meristem to assess for the presence or absence of the transformed cells and the number thereof. The reference further discloses assaying the transformed plants for disease resistance, wherein presence and expression of the transgene was confirmed due to resistance to rust disease. The reference also discloses that following DNA transfer and regeneration, putatively transformed plants may also be evaluated, for instance using Southern analysis, for the presence of the gene of interest, and copy number The reference further discloses that expression levels of the newly introduced DNA may be monitored using Northern and/or Western analysis. The reference further discloses obtaining transgenic seeds and raising transgenic progenies from regenerated transformed plants, and wherein the transgenic seeds and raising transgenic progenies comprise the transgene of the transformation event. The reference also discloses that infection with said Agrobacterium solution comprises an infection step and an incubation step. The reference further discloses that said infection step is performed for at least 30 to 60 minutes, and the incubation step is for at least 3 to 5 days in dark. The reference further discloses that said transformed plant is derived from 4 to 8 day seedling explants. The reference further discloses that said axillary meristem is a cotyledonary axillary bud and wherein the method also comprises removing cotyledon of the plant prior to removing the shoot apical meristem. The reference also discloses that seedling explants were prepared from plantlets by cutting 0.5 to 1.0 cm below the axillary node on the internode and removing the petiole and leaf from the explant. The reference also discloses that infected epicotyl explants were placed on a shoot induction medium with selection agents such as imazapyr for AHAS gene glufosinate for bar gene or D-serine for dsdA gene, after 2 to 4 weeks the explants were transferred to shoot elongation medium containing a selection compound, spraying the plant with the selection agent, or applying the selection agent to the wounded area of the explant or the corresponding area of the plant, or a combination thereof. The reference further discloses that the infected epicotyl explants were placed on a shoot induction medium with selection agents such as imazapyr for AHAS gene glufosinate for bar gene or D-serine for dsdA gene, after 2 to 4 weeks the explants were transferred to shoot elongation medium containing a selection compound, spraying the plant with the selection agent, or applying the selection agent to the wounded area of the explant or the corresponding area of the plant, optionally wherein it occurs for up to 4 weeks, occurs for up to 2 weeks and up to 5 weeks. It may be noted the claim 30 reads on Schultheib et al. teachings because seedling explants are derived from seed. See in particular, abstract, pages 1-22, Figures 1-11; Tables 1-3; examples 1-11, pages 23-37; also see page 16, lines 39, 40; page 35, lines 35-36; page 32, lines 31-35.
Accordingly, Schultheib et al. anticipated the claimed invention.
8. Claim 30 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al. (US Patent Publication NO. 2008/0229447 A1; Published September 18, 2008).
Hwang et al. disclose an organogenic method for transforming soybean cells or tissues, comprising: preparing an explant from an immature soybean seed, the method further comprising wounding a plumule, cotyledonary node region, hypocotyl, or combination thereof in the explant, the method further comprising contacting the explant with a genetic construct, the method further comprises that Agrobacterium-mediated gene transfer, wounding of the explant
tissue can be used to facilitate gene transfer, the method further comprises that the nucleic acid to be transferred can be contained within an expression cassette, the method further discloses that the expression cassette comprising the nucleotide sequence of interest can be chimeric, meaning that at least one of its components is heterologous with respect to at least one of its other components, the method further comprising regenerating a shoot into a genetically transformed soybean plant, the method further comprising the transformation step wherein the transformed tissue can be exposed to selective pressure to select for those cells that have received and are expressing the polypeptide from the heterologous nucleic acid introduced by the expression cassette, and agent used to select for transformants can select for preferential growth of cells containing at least one selectable marker insert positioned within the expression cassette and delivered by ballistic bombardment or by Agrobacterium, The method further comprises obtaining seeds and progeny plants of regenerated plants that can be continuously screened and selected for the continued presence of the transgenic and integrated nucleic acid sequence in order to develop improved plant and seed lines. See in particular, Paragraphs [0006], [0008], [0042] [0090] [0126] 0022], [0064].
Accordingly, Huang et al. anticipated the claimed invention.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
9. Claim(s) 1, 11, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Schultheiss et al. (US Patent Publication NO. 2015/0074842 A1; Published March 12, 2015), and further in view of Zhong et al. (US Patent Publication No. 2002/0073445 A1, Published June 13, 2002).
Schultheib et al. teach a method of Agrobacterium mediated transformation of a plant (e.g. soybean, Arabidopsis, dicots) with a recombinant vector comprising a recombinant DNA construct which comprises a heterologous promoter operably linked to a heterologous polynucleotide comprising a coding sequence and wherein said coding sequence is encoding a protein of interest (e.g. CL protein) imparting rust resistance to Arabidopsis and soybean, and wherein the vector further carries a polynucleotide sequence encoding selection marker (such as bar gene), the method comprising steps of: a) providing a plant comprising an axillary meristem and a shoot apical meristem, b) removing or wounding (encompasses cutting) at least part of the axillary meristem to produce a wounded axillary meristem region, c) contacting the wounded axillary meristem region with recombinant DNA construct comprising said polynucleotide and/or with Agrobacterium solution carrying said recombinant plasmid having said heterologous polynucleotide under conditions where the heterologous polynucleotide enters wounded axillary meristem region, d) removing the shoot apical meristem or suppressing the growth of the shoot apical meristem to produce a wounded explant, e) culturing the wounded explant in a medium in vitro to promote cell proliferation and regeneration, and f) growing the wounded explant in a proper medium and applying selection agent to the resulting plant in planta to select for a transgenic shoot, and wherein the method comprises removing or suppressing the shoot apical meristem at the same time as step b). The reference also teaches that said method produces a chimeric plant with at least one transgenic shoot. The reference further teaches selecting transformed tissues by exposing them to selection marker which are encoded by plant expressible genes co-transferred with the gene of interest, following which the transformed material is regenerated into a whole plant. The reference also teaches that infected explants are placed on shoot induction medium with selection agents such as glufosinate (a herbicide). The infected epicotyl explants were then placed on a shoot induction medium with selection agents such as imazapyr (for AHAS gene), glufosinate (for bar gene, herbicide resistance), or D-serine (for dsdA gene). The regenerated shoots were subcultured on elongation medium with the selective agent. The reference clearly teaches contacting plant with said selection agent to eliminate or reduce untransformed tissue and wherein the selection agent occurs during or after instant step e) which involves growing the transformed plant to regenerate at least part of the wounded axillary meristem region to produce a regenerated transformed axillary meristem or shoot. The reference further teaches contacting with selection agent comprises adding the selection agent to a medium in which the transformed plant is growing and untransformed plant is unable to grow. Alternatively, the selection agent is applied to wounded axillary meristem regions and/or regenerated axillary meristem. The transformed tissue explants were placed on said selection agent to at least 2-3 weeks. The reference further teaches performing an assay on the transformed tissues, regenerated axillary meristems or a sample of the regenerated axillary meristem to assess for the presence or absence of the transformed cells and the number thereof. The reference further teaches assaying the transformed plants for disease resistance, wherein presence and expression of the transgene was confirmed due to resistance to rust disease. The reference also teaches that following DNA transfer and regeneration, putatively transformed plants may also be evaluated, for instance using Southern analysis, for the presence of the gene of interest, and copy number The reference further teaches that expression levels of the newly introduced DNA may be monitored using Northern and/or Western analysis. The reference further teaches obtaining transgenic seeds and raising transgenic progenies from regenerated transformed plants, and wherein the transgenic seeds and raising transgenic progenies comprise the transgene of the transformation event. The reference also teaches that infection with said Agrobacterium solution comprises an infection step and an incubation step. The reference further teaches that said infection step is performed for at least 30 to 60 minutes, and the incubation step is for at least 3 to 5 days in dark. The reference further teaches that said transformed plant is derived from 4 to 8 day seedling explants. The reference further teaches that said axillary meristem is a cotyledonary axillary bud and wherein the method also comprises removing cotyledon of the plant prior to removing the shoot apical meristem. The reference also teaches that seedling explants were prepared from plantlets by cutting 0.5 to 1.0 cm below the axillary node on the internode and removing the petiole and leaf from the explant. The reference also teaches that infected epicotyl explants were placed on a shoot induction medium with selection agents such as imazapyr for AHAS gene glufosinate for bar gene or D-serine for dsdA gene, after 2 to 4 weeks the explants were transferred to shoot elongation medium containing a selection compound, spraying the plant with the selection agent, or applying the selection agent to the wounded area of the explant or the corresponding area of the plant, or a combination thereof. The reference further teaches that the infected epicotyl explants were placed on a shoot induction medium with selection agents such as imazapyr for AHAS gene glufosinate for bar gene or D-serine for dsdA gene, after 2 to 4 weeks the explants were transferred to shoot elongation medium containing a selection compound, spraying the plant with the selection agent, or applying the selection agent to the wounded area of the explant or the corresponding area of the plant, optionally wherein it occurs for up to 4 weeks, occurs for up to 2 weeks and up to 5 weeks. See in particular, abstract, pages 1-22, Figures 1-11; Tables 1-3; examples 1-11, pages 23-37; also see page 16, lines 39, 40; page 35, lines 35-36; page 32, lines 31-35.
Schultheiss et al. do not explicitly teach wherein step (i) is performed prior to step (iii).
Zhong et al. teachings are related to the methods for stable transformation of plants. In light of this, Zhong et al. teach adding a selection agent to a medium in which a plant is maintained prior to applying a selection agent to a wounded area of an explant or a corresponding area of a plant after co-cultivation at ACC medium for two to four days, the infected explants are transferred to a shoot multiplication/selection medium (MSS) and grown for two weeks. Zhong et al. further teach that subsequent subcultures and selection are carried out at two-week intervals and with each subculture, mannose-resistant green shoot clumps are selected, cut into smaller pieces and transferred to fresh MSS medium.
Applicant’s attention is drawn to paragraph [0094], which says:
“[0095] After co-cultivation at ACC medium for two to four days, the infected explants are transferred to a shoot multiplication/selection medium (MSS) and grown at 25.degree. C. under light for two weeks. Subsequent subcultures and selection are carried out at two-week intervals. With each subculture, mannose-resistant green shoot clumps are selected, cut into smaller pieces and transferred to fresh MSS medium. The MSS medium consists of SM medium and antibiotics, either with or without mannose. The concentration of mannose in MSS medium is gradually increased from 0 g/L to 2 g/L, 3 g/l and 4 g/L through the subsequent selection while the concentration of sucrose is decreased from 30 g/L to 25 g/L and then to 20 g/L.”
Applicant’s attention is drawn to paragraph [0117], which says:
“[0117] To begin inoculation, single colonies of A. tumefaciens are collected together on the original YP culture plate using a sterile loop. For the actual inoculation of each target explant, a sterile scalpel blade is dipped into the collected A. tumefaciens colonies and used to make cuts in the apical and axillary meristem regions of each target. Immediately following this inoculation step, about 4 to 6 .mu.l of MSMG Induction Medium (MS salts, 2 g/L Glucose, MES, and 200 .mu.M acetosyringone) is applied to the wounded surface of each target in some experiments. An effort is made to cut through the center of as many meristematic zones as possible in order to direct gene delivery to shoot meristem producing cells. Ten to twenty target cultures are typically treated in sequence and then allowed to air dry under sterile conditions in a laminar flow hood for 10 minutes. Following the air drying treatment, treated target explants are moved to MSCC co-cultivation medium (MS salts, B5 vitamins, 2 mg/L BA, 30 g/L sucrose, 200 .mu.M acetosyringone). The treated explants are then incubated on MSCC medium for 2-3 days at 22.degree. C. with continuous dark culture.”
It would have been obvious and within the scope of an ordinary skill in the art prior to earliest filing date of the instantly claimed invention to modify the method of Schultheiss et al. to include selective agent addition as taught by Zhong et al. to arrive at the instantly claimed method with a reasonable expectation of success and without any surprising results. Obviously, one of ordinary skill in the art would have been motivated to do so for the purpose of successfully selecting transformed explants for further cultivation as asserted by Zhong et al. too at paragraph [0062].
10. Claim(s) 1, 11, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Schultheiss et al. (US Patent Publication NO. 2015/0074842 A1; Published March 12, 2015), and further in view of Zhong et al. (US Patent Publication No. 2002/0073445 A1, Published June 13, 2002).
Schultheiss et al. teachings are discussed as supra.
Schultheiss et al. do not explicitly teach wherein at least part of step (i) is performed at the same time as at least part of step (iii).
Zhong et al. teachings are related to the methods for stable transformation of plants. In light of this, Zhong et al. teach adding a selection agent to a medium in which a plant is maintained is performed at the same time as applying a selection agent to a wounded area of an explant or a corresponding area of a plant, the seed coat from melon seeds is removed and sowed on a half-strength hormone-free MS medium the cotyledon and petioles are separated from the seedlings and transferred them to MS30 medium MS salts, 30 g/L sucrose before transformation.
Applicant’s attention is drawn to paragraph [0107], which says:
“[0107] The seed coat from melon (Cucumis melo L) seeds is removed using a pair of forceps and the seeds are sterilized for 1 min. in 70% ethanol followed by 10 min. in 1% hydrochloride. The seeds are rinsed three to four times with sterile water and sowed on a half-strength hormone-free MS medium, at 10 seeds per plate. The seeds are germinated at 22-24.degree. C. for 16 hrs at 3000-4000 lux and for eight hours in darkness. After seven days, the cotyledon and petioles are separated from the seedlings and transferred them to MS30 medium (MS salts, 30 g/L sucrose). One day before transformation, an A. tumefaciens culture is started in a universal tube by transferring 50.mu.l of a stock solution into 5 ml LB medium containing antibiotics. The culture is incubated at 28.degree. C. at 150 rpm for a minimum of 17 hours.”
Applicant’s attention is drawn to paragraph [0108], which says:
“[0108] On the day of transformation, 1.2 to 1.5 ml of the overnight-grown Agrobacterium culture is added to the plates containing the cotyledons (final Agrobacterium concentration: 2.times.10.sup.8 cfu/ml). Small incisions (wounding) are made in the cotyledon petioles at the site of the meristem. The plates with Agrobacterium +explants are transferred in a vacuum dessicator. Vacuum is applied by a vacuum pump for 1 minute. The vacuum is held for 15 minutes. After 15 minutes the vacuum is released slowly. The Agrobacterium suspension is soaked off the plate. The explants are washed with liquid MS30 by adding MS30 to the plates. The MS30 is soaked from the plates and the explants are dried on sterile filter paper. The explants are placed on BM4.5+0.5 mg/l BAP (BM4.5B), at 20-30 explants per plate. The plates are incubated at 21-23.degree. C. for 16 hours at 1500-2000 lux and then for eight hours of darkness for five days. After five days of co-cultivation, the explants are transferred to a selection medium containing mannose, 0.5 mg/L BA, 0.125 mg/L ancymidol and 1.5 mg/L AgNO.sub.3, at ten explants per plate. The plates are placed at 24.degree. C. for 16 hrs at 2000-2500 lux and then placed in darkness for eight hrs, and transferred every two to 2.5 weeks to fresh medium. Shoots of 0.5 mm and larger are transferred to BMM-c medium that contains MS salts, 0.1 mg/l NM, 3 mg/l AgNO3 and 200 mg/I cefotaxime and 100 mg/l vancomycine. The shoots are transferred every two to three weeks to fresh BMM-c medium.”
It would have been obvious and within the scope of an ordinary skill in the art prior to earliest filing date of the instantly claimed invention to modify the method of Schultheiss et al. to include agent addition as taught by Zhong et al. to arrive at the instantly claimed method with a reasonable expectation of success and without any surprising results. Obviously, one of ordinary skill in the art would have been motivated to do so for the purpose of successfully selecting transformed explants for further cultivation as asserted by Zhong et al. too at paragraph [0062].
11. Claim(s) 1, 2, 7, 8-12, 15-18, 21, 22, 23, 24, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Schultheiss et al. (US Patent Publication NO. 2015/0074842 A1; Published March 12, 2015), and further in view of Jiang et al. (US Patent Publication No. 2007/0033671 A1, Published February 8, 2007).
Schultheiss et al. teachings are discussed as supra.
Schultheiss et al. do not specifically teach removing or suppressing the shoot apical meristem after instant step c).
Jiang et al. teach a method of plant transformation using polynucleotides and/or polynucleotides encoding polypeptides to transform plants to produce transgenic plants with desired properties. For example, Jiang et al. teach modifying expression of G47 transcription factor to reduce apical dominance. The overexpression of G47 polypeptide produced substantial delay in flowering time and caused a marked change in shoot architecture. The flowering in transgenic plant overexpressing G47 polypeptide was delayed by more than a week than wild type control. The inflorescence of the transgenic plants appeared thick with reduced apical dominance. Likewise transgenic plants
homozygous for a T-DNA insertion in the G438 sequence were obtained and these plants exhibited failure in the development of all types of apical meristem. The reference clearly teach suppressing or reducing removing the shoot apical meristem after plant transformation which is after instant step c). Jiang et al. further teach removing or suppressing the shoot apical meristem 5 days after co-cultivation of Agrobacterium suspension carrying recombinant vector for transformation which reads on instant limitation “shoot meristem is removed or suppressed 2-7 days, optionally 3-4 days after contacting” (see claim 4). Jiang et al. also teach suppressing shoot apical meristem is beneficial to produce new and interesting plant varieties in horticulture industry. See in particular, abstract, paragraphs [0363], [0526], [0600], [0081] [0552].
It would have been obvious and within the scope of an ordinary skill in the art prior to earliest filing date of the claimed invention to modify the method of Schultheiss et al. to include suppression of shoot apical meristem as taught by Jiang et al. for the purpose of creating new plant varieties of potential interest to the ornamental horticulture industry as asserted by Jiang et al. and further discussed above. Obviously, one of ordinary skill in the art would have also been motivated to remove at least one the primary leaf of the explant for the purpose of stimulating the growth of the axillary meristems while suppressing the growth of the shoot meristem, and thus arrive at the Applicant’s claimed method with a reasonable expectation of success and without any surprising results.
12. Claim(s) 1, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schultheiss et al. (US Patent Publication NO. 2015/0074842 A1; Published March 12, 2015), and further in view of Chen et al. (Horticulture Research, 5(13): 1-12, published 2018).
Schultheiss et al. teachings are discussed as supra.
Schultheiss et al. do not teach that heterologous polynucleotide comprises one or polynucleotides encoding a genome editing Cas protein and/or a guide RNA.
Chen et al. teach using RNA-guided genome editing using CRISPR/Cas9 based system in targeting an endogenous plant gene to suppress or eliminate its expression in plant cells using Agrobacterium mediated plant transformation but without use of selective marker selection of transformed plants. The reference clearly suggests the advantages and precision of using CRISPR/Cas9 based system of targeting endogenous plant genes from diverse plant species to eliminate or suppress expression or generate desired mutants of said targeted endogenous gene. Chen et al. further teach that CRISPR-Cas9 system can be used as an efficient and powerful tool for gene editing and precise genome editing in plants by using multiple guided RNAs (gRNAs) with a 20-22 nt region designed to pair with distinct genomic sites which are followed by the protospacer-adjacent motif (PAM). Chen et al. clearly suggest that using multiple guided RNAs (gRNAs) to achieve multiple edits within the targeted endogenous gene of the plant cell. See in particular, abstract; Figures 1-4; Tables 1-4; results and discussion, methods, pages 1-12.
Given Chen et al. teach that CRISPR/Cas based system of targeting endogenous plant genes can be efficiently and precisely used in regulating plant gene expression by modifying sequence of an endogenous plant gene and eliminates the use of selection marker to obtain transgenic plants, it would have been obvious and within the scope of an ordinary skill in the art prior to earliest filing date instantly claimed invention to have modified expression vector and its recombinant expression cassette of Schultheiss et al. by either substituting its heterologous polynucleotide with an another polynucleotide sequence encoding Cas9 and guide RNA based gene products of CRISPR/Cas9 system to specifically target endogenous gene of Schultheiss et al. plant(s) to regulate its expression to obtain a desirable phenotype of the transgenic plant with a reasonable expectation of success and without any surprising results.
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.
13. Claims 1, 2, 7, 8-26 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-15, 17-19, 21-26 of copending Application No. 17/775,955 (‘955 thereafter). Although the claims at issue are not identical, they are not patentably distinct from each other because method steps of instant claim 1 are encompassed by the method steps of copending ‘955 Obviously, one of ordinary skill in the art will add selection of agent to copending claim 1 to select transgenic regenerated plant which is routinely done in any plant transformation experimentation as discussed thoroughly in the instant and copending ‘955 application. It would be obvious to use any number of axillary meristems, including two axillary meristems of copending claim 2 to the claimed method of instant claim 1, for the purpose of obtaining multiple transgenic plants derived from multiple axillary meristems as also discussed both in instant and copending ‘955 specification. Additionally, it would be obvious and within the scope of ordinary skill in the art to use axillary meristem tissue derived from any tissue, including leaf, seed epicotyl etc., as a matter of design choice for wounding purposes to incorporate foreign DNA via transformation. This has been thoroughly discussed in the instant and copending ’955 specification. Obviously, one of skilled in the art would try to practice the instantly claimed method in any commercially important dicot and/or monocot plant species derived axillary meristem tissues as a matter of design choice to be starting material for transforming with a polynucleotide of interest at the wounding site. Other than that, dependent instant claims are encompassed and/or recite same limitations as copending ‘955 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
14. Claims 1, 2, 7, 8-26 and 30 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA).
/VINOD KUMAR/Primary Examiner, Art Unit 1663
Prosecution Insights