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 .
Status of the Claims
Claim 3 is canceled.
Claims 1-2 and 4-22 are pending.
Claims 1-2 and 4-22 are examined herein.
Claims 1-2 and 4-22 are rejected.
Priority
Application No. 18/743,454 filed on 06/14/2024 is a continuation of PCT
Application No. PCT/EP2022/086257 and also claims foreign priority to Application No.
EP21215549.3 filed on 12/17/2021.
Claim Rejections - 35 USC § 112
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This is a new rejection from the previous Office Action dated 03/10/2026, necessitated by Applicant’s submission of new Claim 22.
Claim 22 recites “The method according to claim 1, wherein, there are 1 - 21 days in between step ii) and step iii).” In claim 1, step ii) is “removing the shoot apical meristem of the plant at a first location” and step iii) is “regenerating a shoot at a second location in the plant by wounding the plant at the second location one or more days after removing the shoot apical meristem of the plant at the first location, wherein the shoot comprises one or more cells having a genetic modification.”
Step iii) encompasses both wounding a plant at the second location, and regenerating a plant from the second location by wounding the plant.
It is unclear if the 1-21 days between step ii) and step iii) is referring to 1-21 days between removing the shoot apical meristem of the plant at a first location and regenerating a shoot at a second location, or if it is referring to 1-21 days between removing the shoot apical meristem of the plant at a first location and wounding the plant at a second location.
For purposes of examination, the claims are interpreted to mean wherein there is 1-21 days between removing the shoot apical meristem of the plant at a first location and wounding the plant at the second location.
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 1-2, 4-15, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ron (WO-2020051283-A1) and Larriba (Larriba, E., Sánchez-García, A. B., Justamante, M. S., Martínez-Andújar, C., Albacete, A., & Pérez-Pérez, J. M. (2021). Dynamic hormone gradients regulate wound-induced de novo organ formation in tomato hypocotyl explants. International Journal of Molecular Sciences, 22(21), 11843).
This is a maintained rejection from the previous Office Action dated 03/10/2026.
Claim 1 is drawn to a method for producing a shoot of a plant, wherein the shoot comprises one or more cells having a genetic modification, and wherein the method comprises:
introducing in a cell of a plant a vector expressing at least one of a guide element and nuclease element of a site-directed nuclease;
removing the shoot apical meristem of the plant at a first location; and
regenerating a shoot at a second location in the plant by wounding the plant at the second location one or more days after removing the shoot apical meristem of the plant at the first location, wherein the shoot comprises one or more cells having a genetic modification.
Claim 2 is drawn to the method according to claim 1, wherein removal of the shoot apical meristem is by decapitation.
Claim 4 is drawn to the method according to claim 1, wherein regeneration of the shoot is by decapitation.
Claim 5 is drawn to the method according to claim 1, wherein the first location is above the cotyledons.
Claim 6 is drawn to the method according to claim 5, wherein the first location is in the epicotyl above the cotyledons and below the first true leaves.
Claim 7 is drawn to the method according to claim 1, wherein the second location is below the cotyledons.
Claim 8 is drawn to the method according to claim 7, wherein the second location is in the hypocotyl below the cotyledons.
Claim 9 is drawn to the method according to claim 1, wherein the site-directed nuclease is selected from the group consisting of a CRISPR-nuclease complex, an Argonaute, a Zinc finger nuclease, a TALEN and a meganuclease.
Claim 10 is drawn to the method according to claim 1, wherein the site-specific nuclease is a CRISPR-nuclease complex, wherein the plant expresses the nuclease element of the complex, and the vector expresses a gRNA.
Claim 11 is drawn to the method according to claim 1, wherein the period between the introducing (i) and the removing (ii) is 1 - 21 days.
Claim 12 is drawn to method according to claim 11, wherein the period is 1 - 7 days.
Claim 13 is drawn to the method according to claim 1, wherein the plant is a seedling.
Claim 14 is drawn to the method according to claim 1, wherein the introduced vector is a virus.
Claim 15 is drawn to the method according to claim 14, wherein the virus is selected from the group consisting of a Tobacco Rattle Virus (TRV), a Tobacco Mosaic Virus (TMV), a Potato virus X (PVX), a geminivirus, a Sonchus yellow net virus (SYNV).
Claim 18 is drawn to the method according to claim 1, further comprising (iv) selecting the shoot comprising one or more cells having a genetic modification and regenerating a plant thereof.
Claim 19 is drawn to the method according to claim 1, further comprising (iv) growing the plant to produce a gamete comprising the genetic modification.
Claim 20 is drawn to the method according to claim 19, further comprising (v) growing a seed from the gamete and optionally a progeny plant from the seed, wherein the seed and optional progeny plant comprises one or more cells having the genetic modification.
Claim 21 is drawn to a plant having a shoot comprising one or more cells having a genetic modification, wherein the plant is obtainable by the method according to claim 1.
Regarding claim 1, Ron teaches generating transgenic tomato plants expressing Cas9 and the negative selection marker Herpes Simplex Virus-I Thymidine Kinase (HSVtk) (¶0078-0079), then transiently expressing sgRNAs in the plant using a viral expression system (¶0080) (i.e. part (i) introducing in a cell of a plant a vector expressing at least one of a guide element and nuclease element of a site-directed nuclease). Ron teaches the Cas9 expressing mother plants were injected with the viral replicon vector for sgRNA expression, then the plants were decapitated at the epicotyl a week later, then regenerated shoots that developed were detached from the decapitation site and propagated (i.e. removing the shoot apical meristem of the plant at a first location and regenerating a shoot) (¶0093). Ron further discloses mutation level and type were analyzed by PCR and sequencing of amplicons flanking the target genomic sites, and regenerated stems were evaluated for mutation in the marker and POTATO LEAF (C) sequences and the expected change in leaf shape typical of a C knockout (i.e. wherein the shoot comprises one or more cells having a genetic modification) (¶0093). Ron teaches approximately 11-25% of regenerated shoots (up to 25% if additional Cas9 nuclease is injected into the Cas9-expressing mother plant at the time of injecting the viral replicon vector for sgRNA expression) had mutations in both targeted C and HSVtk genes (¶0121, Table 2).
Regarding claim 2, Ron teaches the seedlings were decapitated at the epicotyl (¶0093).
Regarding claim 4, Ron teaches shoots are regenerated from the wound site that is decapitation (¶0093).
Regarding claims 5-6, Ron teaches the seedlings were decapitated at the epicotyl (¶0093) (i.e. above the cotyledons and below first true leaves).
Regarding claim 9, Ron teaches the site-directed nuclease is Cas9 (i.e. a CRISPR-nuclease complex) (¶0080, 0082-0083, 0093).
Regarding claim 10, Ron teaches the plant expresses Cas9 and the sgRNAs are transiently expressed using a viral replicon vector (i.e. wherein the site-specific nuclease is a CRISPR-nuclease complex, wherein the plant expresses the nuclease element of the complex, and the vector expresses a gRNA) (¶0078-0080, 0087, 0093).
Regarding claims 11-12, Ron teaches the Cas9 expressing mother plants were injected with the viral replicon vector for sgRNA expression, then the plants were decapitated at the epicotyl a week later (i.e. the period between introducing and removing is a week or 7 days) (¶0093).
Regarding claim 13, Ron teaches the plant is a seedling (¶0093).
Regarding claim 14, Ron teaches the introduced vector is a viral replicon vector (i.e. wherein the introduced vector is a virus) (¶0093).
Regarding claim 15, Ron teaches the virus is Tobacco Rattle Virus (TRV) (¶0080, 0087).
Regarding claim 18, Ron teaches regenerated shoots that developed were detached from the decapitation site and propagated, mutation level and type were analyzed by PCR and sequencing of amplicons flanking the target genomic sites, and regenerated stems were evaluated for mutation in the marker and POTATO LEAF (C) sequences and the expected change in leaf shape typical of a C knockout (i.e. selecting the shoot comprising one or more cells having a genetic modification and regenerating a plant thereof) (¶0093).
Regarding claims 19-20, Ron teaches all shoots that were detached from the decapitation site were propagated to fruiting then analyzed for mutation (¶0093) and also teaches selected double mutants at HSVtk and C have been taken to the next generation to test for heritability (¶0126).
Regarding claim 21, Ron teaches the decapitated plant produced shoots that comprised the genetic mutations (¶0093).
However, Ron does not explicitly teach in a single embodiment:
regenerating a shoot at a second location in the plant by wounding the plant at the second location one or more days after removing the shoot apical meristem of the plant at the first location (remaining limitation of claim 1)
the method according to claim 1, wherein the second location is below the cotyledons (claim 7)
the method according to claim 7, wherein the second location is in the hypocotyl below the cotyledons (claim 8)
the method according to claim 1, further comprising (iv) growing the plant to produce a gamete comprising the genetic modification (claim 19)
the method according to claim 19, further comprising (v) growing a seed from the gamete and optionally a progeny plant from the seed, wherein the seed and optional progeny plant comprises one or more cells having the genetic modification (claim 20)
Regarding the remaining limitation of claim 1 and claims 7-8, in an alternative embodiment, Ron teaches wound generation/ shoot decapitation in the stem or hypocotyl or epicotyl, or runners, or internodes, seedlings or woody buds will generate a wound and reprogramming to produce axillary buds or callus and new shoots (¶0070). Ron teaches thus in some embodiments, the wound is formed at the location at which the nuclease and/or guide molecule(s) have been introduced to the plant (¶0070). In other analogous art, Larriba further teaches de novo shoot formation is observed in tomato from explants decapitated at the hypocotyl (below the cotyledons) (p. 2, ¶1, Fig. 1).
Regarding claims 19-20, in an alternative embodiment, Ron teaches generating transgenic tomato plants expressing Cas9 and the negative selection marker D-amino acid oxidase (DAAO) (¶0078-0079), then transiently expressing sgRNAs in the plant using a viral expression system to knockout the DAAO gene and also the ENTIRE gene for visual confirmation of gene-editing (¶0080). In this alternative embodiment, Ron also teaches a regenerated stems from the decapitation site were evaluated for mutation in the marker and ENTIRE sequences and the expected change in leaf shape typical of an ENTIRE knockout (¶0092). Ron teaches the plants were propagated to fruiting and heritability of the phenotype and genotype was determined, and further teaches plants without Cas9 segregated from these T1 and showed heritable E mutant phenotypes (¶0091 and 0117) (i.e. because the mutations were heritable into the progeny plants, the plant must have been grown to produce a gamete comprising the genetic modification, and the seed grown from the gamete and optionally a progeny plant from the seed, wherein the seed and optional progeny plant comprises one or more cells having the genetic modification).
It would be prima facie obvious to combine the teachings of Ron and Larriba for the purpose of regenerating more gene-edited shoots from the plant because Ron teaches i. decapitation at either location where the nuclease and/or guide molecule(s) have been introduced will result in shoot regeneration (¶0070), and ii. a low number of shoots regenerated from a single decapitation event comprise mutations at all targeted sites (Table 2). Therefore, the steps of decapitation at both locations were known in the prior art, their combination does not change the function of performing each step separately, and it would be prima facie obvious to combine the steps to produce more regenerated shoots with the targeted edits. One having ordinary skill in the art would have a reasonable expectation of regenerating the instantly claimed shoots by decapitating first at the epicotyl then at the hypocotyl success because Ron and Larriba teach shoots, including gene-edited shoots, can be regenerated from decapitation at both locations, and the combination of the steps does not present any special technical difficulties. Furthermore, one having ordinary skill in the art would have been motivated to combine the alternative embodiments of Ron for the purpose of generating progeny plants having the inherited mutation and the Cas9 T-DNA segregated out (¶0091 and 0117). One would have a reasonably expectation of success in generating gametes, seeds, and progeny plants having the mutation because in an alternative embodiment Ron shows the mutations are heritable.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ron and Larriba as applied to claims 1, 14, and 15 above, and further in view of Lindbo (Lindbo, J.A. (2007). TRBO: a high-efficiency tobacco mosaic virus RNA-based overexpression vector. Plant physiology, 145(4), 1232-1240).
This is a maintained rejection from the previous Office Action dated 03/10/2026.
Claim 16 is drawn to the method according to claim 15, wherein the virus is a tobacco mosaic virus RNA-based overexpression vector (TRBO).
Regarding claim 16, Ron and Larriba teach the limitations of claims 1, 14, and 15 as set forth in the previous obviousness rejection. The teachings of Ron and Larriba as they are applied to claims 1, 14, and 15 are set forth previously herein and are incorporated by reference.
However, Ron and Larriba do not explicitly teach wherein the virus is a tobacco mosaic virus RNA-based overexpression vector (TRBO).
In analogous art, Lindbo teaches about the construction of an improved
agroinfection-compatible TMV vector that lacks the TMV CP gene coding sequence,
called the TMV RNA-based overexpression (TRBO) vector (p. 1233, 4-5). Lindbo teaches that the TRBO vector will be a useful transient expression vector for production of recombinant proteins in plants (p. 1233, 4-5).
It would therefore have been obvious to a person of ordinary skill in the art to
modify the invention of as taught by Ron and Larriba to include the limitations of Lindbo to arrive at the instantly claimed method with a reasonable expectation of success because both methods are directed to Agroinfection of plants with a viral vector, and successful incorporation of the TRBO vector taught by Lindbo into the method taught by Ron could be achieved by one of ordinary skill in the art without encountering any special technical obstacles. One having ordinary skill in the art would have been motivated to do so because Lindbo teaches the TRBO vector has several significant improvements, such as (1) much higher agroinfection efficiency; (2) higher recombinant protein expression levels; and (3) inability to form virus particles during its infection/ replication cycle (p. 1233, 14-5).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ron and Larriba as applied to claim 1 above, and further in view of Mahas (Mahas, A., Ali, Z., Tashkandi, M., & Mahfouz, M.M. (2019). Virus-mediated genome editing in plants using the CRISPR/Cas9 system. In Plant Genome Editing with CRISPR Systems: Methods and Protocols (pp. 311-326). New York, NY: Springer New York).
This is a maintained rejection from the previous Office Action dated 03/10/2026.
Claim 17 is drawn to the method according to claim 1, wherein the introducing is
by contacting the cotyledon with an agrobacterium or virus particle carrying the vector.
Regarding claim 17, Ron and Larriba teach the limitations of claim 1 set forth in the previous obviousness rejection. The teachings of Ron and Larriba as they are applied to claim 1 set forth previously herein and are incorporated by reference.
However, Ron does not explicitly teach wherein the introducing is by contacting
the cotyledon with an agrobacterium or virus particle carrying the vector.
In analogous art, Mahas teaches about virus-mediated genome editing in plants
using CRISPR/Cas9 system (title). Specifically, Mahas teaches using the Tobacco
Rattle Virus to employ CRISPR/Cas9 genome editing, and teaches the initially infected
cells, such as leaves, presumably serve as a source for further replication of viral RNAs
and their systemic infection and spread into a variety of tissues and cells, such as
developing and meristematic tissues, including germline cells (p. 313, ¶2, Fig. 1).
It would therefore have been obvious to a person of ordinary skill in the art to
modify the invention of as taught by Ron and Larriba to include the limitations of Mahas to arrive at the instantly claimed method with a reasonable expectation of success because Mahas also teaches a method of Tobacco Rattle Virus (TRV)-mediated genome editing via agroinfection of plants, and Mahas teaches the utilization of TRV leads to further replication of viral RNAs and their systemic infection throughout the plant (p. 313, ¶2, Fig. 1). It would therefore be obvious to introduce the Agrobacterium comprising the recombinant TRV vectors into any tissue of the plant, including the cotyledons as instantly claimed, because Mahas teaches TRV is an effective vehicle for systemic delivery of CRISPR/Cas9 elements, and their systemic infection will spread into a variety of tissues and cells, such as developing and meristematic tissues, including germline cells plant (p. 313, ¶2-3, Fig. 1).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ron and Larriba as applied to claim 1 above, and further in view of Tezuka (Tezuka, T., Harada, M., Johkan, M., Yamasaki, S., Tanaka, H., & Oda, M. (2011). Effects of auxin and cytokinin on in vivo adventitious shoot regeneration from decapitated tomato plants. HortScience, 46(12), 1661-1665.).
This is a new rejection from the previous Office Action dated 03/10/2026, necessitated by Applicant’s submission of new Claim 22.
Claim 22 is drawn to the method according to claim 1, wherein, there are 1 - 21 days in between step ii) and step iii).
Regarding claim 22, Ron and Larriba teach the limitations of claim 1 set forth in the previous obviousness rejection. The teachings of Ron and Larriba as they are applied to claim 1 set forth previously herein and are incorporated by reference.
However, Ron does not explicitly teach wherein, there are 1 - 21 days in between step ii) and step iii).
In analogous art, Tezuka teaches decapitating tomato plants, then excising lateral branches 14 days later (p. 1662, section titled Effect of the presence of lateral branches). Tezuka teaches removing all lateral branches 14 days after decapitation increased adventitious shoot formation from the primary shoot, and adventitious shoots were also developed from the cut surface of the lateral branches (p. 1663, section titled Presence of lateral branches decreased the number of adventitious shoots).
It would therefore have been obvious to one of ordinary skill in the art to combine the teachings of Ron and Larriba with Tezuka to arrive at the instantly claimed method with a reasonable expectation of success because further injecting the lateral branches with the sgRNA vector of Ron then removing the lateral branches 14 days after decapitation of the tomato plant could be achieved by the ordinary artisan without encountering any special technical difficulties. One of ordinary skill in the art would have been motivated to do so for the purpose of obtaining more adventitious shoots because Tezuka teaches adventitious shoots were also developed from the cut surface of the lateral branches, and removing all of the lateral branches 14 days after tomato plant decapitation increases the overall number of adventitious shoots recovered from the tomato plant (i.e. adventitious shoots produced from both the primary and lateral cuts) (p. 1663, section titled Presence of lateral branches decreased the number of adventitious shoots, and Table 1).
Response to Arguments
Applicant argues beginning on p. 5 of remarks dated 06/10/2026 the
following arguments:
Claims 1-2, 4-15, and 18-21 stand rejected under 35 U.S.C. 103(a) as allegedly
unpatentable over WO-2020051283 ("Ron") in view of Larriba et al., International Journal of Molecular Sciences. (2021) 22(21):11843 ("Larriba"). Claim 16 stands rejected under 35 U.S.C. 103(a) as allegedly unpatentable over Ron and Larriba as applied to claims 1, 14, and 15 above, and further in view of Lindbo et al., Plant physiology. (2007) 145(4):1232-1240 ("Lindbo"). Claim 17 stands rejected under 35 U.S.C. 103(a) as allegedly unpatentable over Ron and Larriba as applied to claim 1 above, and further in view of Mahas et al., In Plant Genome Editing with CRISPR Systems: Methods and Protocols. (2019) 311-326 ("Mahas"). Applicant respectfully traverses this rejection on the following grounds.
At the outset, Applicant maintains that Ron does not teach or suggest "decapitated at the first internode" and "regenerating a shoot at a second location" as recited by the present claims because the decapitation according to Ron at paragraph [0093] is performed at a single location in a single step. In particular, paragraph [0093] of Ron teaches that "we decapitated the seedlings at the first internode so that cells that were genome edited could form a callus, regenerate new meristems and stems. The Cas9 expressing mother plants were injected with the viral replicon vector and decapitated at the epicotyl a week later." (Emphasis added). In other words, Ron teaches decapitation in the first sentence of paragraph [0093], and the second sentence only further explains that the genome editing was performed by first injecting the Cas9 expressing mother plants with the viral replicon vector to obtain the genome edited cells referenced in the first sentence. Accordingly, the first two sentences of Ron refer to the same step of decapitation, and Ron only teaches or discloses a single step of decapitation at a single location. Thus, Ron does not teach, suggest, or disclose "removing the shoot apical meristem of the plant at a first location; and ... regenerating a shoot at a second location in the plant by wounding the plant at the second location one or more days after removing the shoot apical meristem of the plant at the first location," as recited by the present claims.
The Office Action alleges at pages 9-10 (bridging par.) that the prior art, including Ron at par. [0070], teach that "the steps of decapitation at both locations were known in the prior art, their combination does not change the function of performing each step separately, and it would be prima facie obvious to combine the steps to produce more regenerated shoots with the targeted edits." Applicant respectfully disagrees with this conclusion in the Office Action because Ron in par. [0070] does not teach combining any steps and refers only to several alternatives for generating a wound, i.e. "Shoot decapitation in the stem or hypocotyl or epicotyl, or runners, or internodes, seedlings or woody buds will generate a wound and reprogramming to produce axillary buds or callus and new shoots." (Emphasis added). A person of ordinary skill in the art would understand that one of the listed options can be selected to generate a wound and would consider these options as mutually exclusive. There is no motivation in Ron to generate a wound twice or to combine two alternatives.
In addition, Larriba teaches away from the presently claimed method. Larriba concerns hypocotyl explants to study the development of adventitious roots (AR) and de novo formed shoots (Fig. 1). Hypocotyl explants can be produced by decapitation of a plant and maintaining the decapitated part (i.e. the hypocotyl explant) for the subsequent development of roots and shoots. In contrast, in the present claim 1, the decapitated part of the plant is removed. Larriba therefore teaches away from the presently claimed invention.
Contrary to what is alleged at page 10 in the Office Action, it would not "be prima facie obvious to combine the steps to produce more regenerated shoots with the targeted edits." There is no teaching or suggestion in Ron that removing the shoot apical meristem of a plant at a first location and then wounding the plant at a second location increases the number of de novo formed shoots, as compared to either removing the shoot apical meristem of a plant at a first location or wounding the plant at a second location. Indeed, Ron teaches a single wounding step and there is no motivation provided to perform the step twice. Accordingly, the present claims are nonobvious over Ron and Larriba.
Newly added claim 22 provides an additional reason for non-obviousness because Ron does not teach or suggest a step of wounding a plant at a first and a second location and that there are 1 - 21 days in between removing the shoot apical meristem at the first location and wounding the plant at the second location.
For at least these reasons, withdrawal of the outstanding rejection is respectfully solicited.
Examiner’s Response:
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
Specifically regarding Applicant’s argument that Ron and/ or Larriba does/do not teach, suggest, or disclose "removing the shoot apical meristem of the plant at a first location; and ... regenerating a shoot at a second location in the plant by wounding the plant at the second location one or more days after removing the shoot apical meristem of the plant at the first location," is not persuasive. Applicant points out that Ron discloses in a single decapitation step at a single location. However, it is important to also consider that Ron discloses various known locations where the nuclease and/or guide molecule(s) are been introduced will result in shoot regeneration (¶0070) and that a low number of shoots regenerated from a single decapitation event comprise mutations at all targeted sites (p. 38, Table 2), as stated in the 103 rejection. The MPEP states rationale to modify or combine the prior art does not have to be expressly stated in the prior art and the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art (MPEP 2144.I). In the instant case, Ron teaches a low number of shoots (11-24%) were regenerated that had mutations at both target sites from the single decapitation (see p. 38, Table 2), and one of ordinary skill in the art would have reasoned from general knowledge that the plant can be decapitated a second time at a second location (after collecting regenerated shoots from the first decapitation event) that is known in the art and taught by Ron and Larriba to be able to regenerate shoots for the purpose of obtaining more edited shoots. The MPEP further recognizes that combining equivalents known for the same purpose is obvious (2144.06.I). In the instant case, decapitation at both locations were known in the prior art, their combination does not change the function of performing each step separately, and it would be prima facie obvious to combine the step of decapitation at one known location then another known location for the same purpose that is to produce regenerated shoots with the targeted edits. For these reasons, Applicant’s argument is not found persuasive.
Regarding Applicant’s argument that Larriba teaches away from the presently claimed method because “Larriba concerns hypocotyl explants to study the development of adventitious roots (AR) and de novo formed shoots (Fig. 1). Hypocotyl explants can be produced by decapitation of a plant and maintaining the decapitated part (i.e. the hypocotyl explant) for the subsequent development of roots and shoots. In contrast, in the present claim 1, the decapitated part of the plant is removed. Larriba therefore teaches away from the presently claimed invention”, this is not persuasive. Larriba is used as motivation and evidence that adventitious shoots are known in the art to successfully regenerate from a cut at the hypocotyl. Larriba provides further support that decapitation at another location taught by Ron (the hypocotyl) can produce adventitious shoots, and the disclosure of Larriba does not criticize, discredit, or otherwise discourage the method claimed (i.e. teach away). For this reason, this argument is not persuasive.
Regarding Applicant’s argument that newly added claim 22 provides an additional reason for non-obviousness because Ron does not teach or suggest a step of wounding a plant at a first and a second location and that there are 1 - 21 days in between removing the shoot apical meristem at the first location and wounding the plant at the second location, this is also not found persuasive. New claim 22 is rejected under 35 USC 103 in view of Ron, Larriba, and Tezuka. As stated in the 103 rejection previously herein, Tezuka teaches decapitating tomato plants, then excising lateral branches 14 days later (p. 1662, section titled Effect of the presence of lateral branches). Tezuka teaches this increased adventitious shoot formation from the primary shoot, and adventitious shoots were also developed from the cut surface of the lateral branches (p. 1663, section titled Presence of lateral branches decreased the number of adventitious shoots). Thus, Tezuka teaches decapitating a tomato plant then wounding at a second location that is the base of the lateral branches, wherein there is 14 (i.e. 1-21) days between decapitation and wounding at the second location, and wherein the second location develops adventitious shoots. As stated in the 103 rejection, it would be obvious to combine the teachings of Ron and Tezuka for the purpose of obtaining more edited shoots because Tezuka teaches removing all of the lateral branches 14 days after decapitation increases the overall number of adventitious shoots recovered from the tomato plant (i.e. from cuts at both lateral branch and primary shoot). For this reason, Applicant’s argument is not found persuasive.
Conclusion and Inquiries
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA N STOCKDALE whose telephone number is (703)756-5395. The examiner can normally be reached M-F 8:30-5:00 CT.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662
Prosecution Insights