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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/03/2026 has been entered.
Claim Status
Claims 1-17 and 20-22 are pending. Claims 1, 4 and 6 are amended. Claims 21 and 22 are newly added. Claims 18 and 19 are canceled. Claims 1-17 and 20-22 are examined on the merits.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-11, 14-15, and 20 are rejected under 35 U.S.C. §103 as being unpatentable over Feeney (Mistianne Feeney et. al., Plant Cell Tiss Organ Cult (2007) 90:201–214) in view of Matand (Kanyand Matand et. al., BMC Plant Biology (2020) 20:31, pp1-10) and Chung (Hsiao-Hang Chung et. al., Plants 2021, 10, 67, pp1-14).
Claim 1 is drawn to a method of producing an organogenic callus, the method comprising: wounding a plant or plant part comprising stem tissue including a node to provide a wounded tissue; and culturing the wounded tissue in dark on media comprising thidiazuron (TDZ) at a concentration of at least about 5 mg/L of the media, thereby producing the organogenic callus.
Feeney teaches using Prunus avium explants derived from shoot/stem tissues: “Leaves and petioles were removed from shoots with a scalpel. Shoots were then divided into three explant types: apical tips, stems, and shoot bases. Explants of each type were collected and pooled”(page 203, In-vitro explants). Feeney’s shoot/stem/shoot-base explants are plant parts comprising stem tissue, and preparation of these explants by cutting with a scalpel provides wounded tissue. Under the broadest reasonable interpretation, use of stem/shoot-base explants including node-associated tissue would have been an obvious selection of explant material for woody plant tissue culture and regeneration. Feeney further teaches “explants forming organogenic callus was recorded after 3 months” (page 203, “In-vitro explants”).
Feeney does not teach culturing the wounded tissue on media comprising thidiazuron (TDZ) at a concentration of at least about 5 mg/L of the media. Feeney further does not teach conducting the callus-induction culture in darkness.
Matand teaches sectioning stem tissue into explants and culturing the wounded stem explants on media containing TDZ at 1, 5, or 10 mg/L (p4, left column, pa2). Matand teaches that the wounded stem surfaces undergo callus/organogenic development and that 5 and 10 mg/L TCZ provides strong organogenic response (p5, right column, pa1). Matand further teaches that callus develops meristematic regions associated with subsequent organogenesis (Fig. 2f).
Chung teaches TDZ-mediated callus induction under dark conditions and expressly teaches that, in general, dark conditions were more suitable than light for callus induction. Chung obtained up to 100% callus induction after two weeks of culture in darkness (p4, pa2). Chung further demonstrates that the induced callus contains meristematic cells that subsequently undergo adventitious shoot organogenesis (p7, pa1).
It would have been obvious to one of ordinary skill in the art to modify the organogenic callus method of Feeney by employing the TDZ concentrations taught by Matand, including 5 or 10 mg/L, because Matand teaches that such concentrations promote organogenic responses from wounded stem tissue. It would further have been obvious to conduct the callus-induction stage in darkness as taught by Chung because Chung expressly teaches that dark conditions are suitable, and generally more favorable than light, for TDZ-mediated callus induction.
Accordingly, one of ordinary skill in the art would have had a reasonable expectation of successfully producing organogenic callus from wounded stem tissue using the claimed culture conditions.
Accordingly, claim 1 would have been obvious over Feeney, Matand, and Chung.
Claim 2 is drawn to the method of claim 1, wherein the stem tissue comprises meristem tissue.
Feeney teaches use of shoot tips/shoot base (apical/lateral shoot tissues) as explants (page 203, In-vitro explants), these explants are understood to include meristematic regions or meristem-adjacent tissue (i.e., meristem tissue present within the stem/shoot explant context).
Therefore, claim 2 would have been obvious for the same reasons set forth above.
Claim 3 is drawn to the method of claim 1, wherein the stem tissue is present in a mixture with other plant tissue.
Feeney teaches preparing and culturing apical tips, stems, and shoot bases as explants for in vitro culture and regeneration/callus formation (page 203, In-vitro explants). Use of stem tissue in combination with other plant tissues during explant preparation and culture would have been a routine variation of explant handling and tissue culture practice. Therefore, claim 3 would have been obvious for the same reasons set forth above.
Claim 5 is drawn to the method of claim 1, wherein the media further comprises a sugar.
Feeney teaches plant tissue culture on basal media (MS) formulations that include a carbohydrate source (commonly sucrose/glucose) as a routine component for explant survival and morphogenesis (page 203, in-vitro explants).
Therefore, claim 5 would have been obvious for the same reasons set forth above.
Claim 6 is drawn to the method of claim 1, wherein culturing the wounded tissue comprises culturing the wounded tissue at a temperature of about 20°C to about 30°C.
Chung teaches “All explants were cultured at a temperature of 25 ± 2 ◦C” (p11, pa4). Therefore, claim 6 would have been obvious for the same reasons set forth above.
Claim 7 is drawn to the method of claim 1, wherein culturing the wounded tissue comprises culturing the wounded tissue on the media for about 4 weeks to about 15 weeks.
Feeney teaches “Explants were subcultured at 4-week intervals. The number of explants forming organogenic callus was recorded after 3 months.”(page 205, last paragraph).
Therefore, claim 7 would have been obvious for the same reasons set forth above.
Claim 8 is drawn to the method of claim 1, wherein the plant or plant part is or is from a plant that is an out-crossing species.
Feeney teaches shoot regeneration from organogenic callus of sweet cherry (Prunus avium). Therefore, claim 8 would have been obvious for the same reasons set forth above.
Claim 9 is drawn to the method of claim 1,wherein the organogenic callus is not a cotyledon-derived organogenic callus and/or the wounded tissue is devoid of a cotyledon.
Feeney teaches using vegetative stem/shoot-derived explants (including node-associated tissues) as starting material for in vitro culture and regeneration/callus formation (page 203, In-vitro explants). Such stem/shoot explants are not cotyledons. Therefore, claim 9 would have been obvious for the same reasons set forth above.
Claim 10 is drawn to the method of claim 1, wherein the organogenic callus is true-to-type relative to the plant or plant part from which the wounded stem tissue was obtained.
As used in claim 10 and in view of instant Application (pa0003-0004) of the specification, “true-to-type” is interpreted as retaining the genetic identity of the donor plant, as distinguished from material derived from a seed of an out-crossing plant that may differ genetically from the parent cultivar.
Feeney teaches producing organogenic callus from vegetatively derived shoot/stem explants of Prunus avium, rather than from seed-derived cotyledons (p203, “In-vitro explants”). Because the callus is derived from somatic stem tissue of the donor plant, one of ordinary skill in the art would have reasonably expected the resulting callus to retain the genetic identity of the donor plant and thus be true-to-type.
Therefore, claim 10 would have been obvious for the same reasons set forth above.
Claim 11 is drawn to the method of claim 1, further comprising forming a plurality of organogenic calluses from a plurality of wounded tissues.
Feeney teaches processing multiple wounded explants on regeneration medium and obtaining callus and shoot regeneration responses from the explants (page 201, abstract). Therefore, claim 11 would have been obvious for the same reasons set forth above.
Claim 14 is drawn to a method of propagating a plant from an organogenic callus, the method comprising: culturing the organogenic callus of claim 1 on media in the presence of light.
For the same reason set forth above with respect to claim 1, Feeney teaches regenerating shoots from organogenic callus of Prunus avium (p203-205). Chung further teaches transferring induced callus to regeneration conditions for adventitious shoot organogenesis under light conditions (p7, pa1).
It would have been obvious to culture the organogenic callus under light on regeneration media because Chung teaches such conditions for regenerating shoots from induced callus.
Therefore, claim 14 would have been obvious for the same reasons set forth above.
Claim 15 is drawn to the method of claim 14, wherein culturing the organogenic callus comprises culturing the organogenic callus on shoot regeneration media to form tissue comprising a shoot and then culturing the tissue comprising a shoot on root regeneration media.
For the same reason set forth above with respect to claim 14, Chung teaches regenerating shoots from induced callus on shoot-regeneration media and subsequently transferring the regenerated shoots to root-regeneration media to induce root formation (p8, “2.4.Root Induction from Shoot Explants Using Different Auxins”). It would have been obvious to apply Chung’s sequential shoot-and root-regeneration procedure to the organogenic callus of Feeney to produce a regenerated plant.
Therefore, claim 15 would have been obvious for the same reasons set forth above.
Claim 20 is drawn to the method of claim 1, wherein the plant or the plant part is from Prunus avium.
Feeney expressly teaches organogenic callus formation and regeneration from Prunus avium explants. Therefore, claim 20 would have been obvious for the same reasons set forth above.
Claims 4, 12, and 21-22 are rejected under 35 U.S.C. §103 as being unpatentable over Feeney (2007) in view of Matand (2020) and Chung (2021) as apply to claim 1 and 11, and further in view of Otani (Yuko Otani et. al., Plant Biotechnology (2013) 30, 141–146).
Claim 1 as the teachings of Feeney, Matand and Chung are discussed above.
Claims 4 and 22 are interpreted as dependent of claim 1.
Claim 12 is interpreted as dependent of claim 11.
Claim 4 is drawn to the method of claim 1, wherein the media comprises TDZ in an amount of about 10 mg/L to about 15 mg/L of the media. Claim 12 is drawn to the method of claim 11, wherein an organogenic callus is formed on at least about 80% of the plurality of wounded tissues. Claim 21 depends from claim 12 and further requires TDZ at about 10 mg/L to about 15 mg/L of the media.
For the same reasons set forth above with respect to claim 1, Otani teaches TDZ concentrations including 5, 10, and 15 mg/L (p142, left column, pa3) and demonstrates efficient nodular callus induction using relative high TDZ concentrations (p143-144, Table 1 and 3).
It would have been obvious to select or optimize TDZ within the known effective range, including about 10-15 mg/L, to promote callus formation. Therefore, claim 4 would have been obvious over Feeney, Matand, Chung and Otani.
For the same reason set forth above with respect to claim 1 and 11, Otani teaches that stem explants cultured with 10 mg/L TDZ produced nodular callus at 100% frequency (p143, Table 2). Accordingly, one of ordinary skill in the art would have reasonably expected TDZ-mediated culture to provide organogenic callus formation on at least about 80% of the TDA-treated stem explants. Accordingly, claims 4, 12 and 21 would have been obvious over Feeney, Matand, Chung and Otani.
Claim 22 depends from claim 1, and further requires forming a plurality of tissues that comprise an organogenic callus, wherein the plurality of tissues is associated with an increase in mass compared to the wounded tissue.
For the same reason set forth above respect to claim 1, Otani further teaches that stem explants cultured with TDZ swell and form nodular calli (p142, right column, pa3). Therefore, the claimed increase in mass would have been an expected results of TDZ-induced callus growth. Accordingly, claim 22 would have been obvious over Feeney, Matand, Chung and Otani
Claims 13, 16-17 are rejected under 35 U.S.C. §103 as being unpatentable over Feeney (2007) in view of Matand (2020) and Chung (2021) as apply to claim 1, and further in view of Clement (Erik William Clement et. al., US11168319B1, Application 2018-02-28, Publication: 2021-11-09).
Claim 1 as the teachings of Feeney, Matand and Chung are discussed above.
Claims 13, 16 and 17 are interpreted as dependent of claim 1.
Claim 13 is drawn to the method of claim 1, further comprising exposing the wounded tissue to an antibiotic.
For the same reasons set forth above with respect to claim 1, Clement teaches plant-dell culture compositions comprising cultured plant cells and optionally an antibiotic as an agent contacting the plant cells (column 48, line 19-20). It would have been obvious to include the antibiotic taught by Clement in the plant-cell culture for its known culture or selection function.
Accordingly, claim 13 would have been obvious over Feeney, Matand, Chung and Clement.
Claim 16 is drawn to a method of transforming an organogenic callus, the method comprising: contacting the organogenic callus of claim 1 and a bacterial cell, thereby transforming the organogenic callus with the bacterial cell to provide a transformed organogenic callus. Claim 17 is drawn to a method of modifying a target nucleic acid, the method comprising contacting the organogenic callus of claim 1, and a bacterial cell, wherein the organogenic callus comprises the target nucleic acid and wherein the bacterial cell comprises and/or encodes an editing system, and the editing system modifies the target nucleic acid, thereby providing a modified organogenic callus.
For the same reason set forth above with respect to claim 1, Clement teaches bacterially mediated delivery of genome-editing components into plant cells, including delivery by Agrobacterium of polynucleotides encoding an RNA-guided nuclease and a guide RNA (Column 37, line 15-53). Thus, Clement teaches contacting plant cells with a bacterial cell to introduce genetic material, as required by claim 16. Clement further teaches genome-editing systems comprising an RNA-guided nuclease, such as Cas9, and a guide RNA for modifying a target nucleotide sequence (Column 39, line 40-45), as required by claim 17.
It would have been obvious to contact the organogenic callus produced by the method of Feeney, as modified by Matand and Chung, with the bacterial cells of Clement to introduce Clement’s genome-editing system into the callus cells. One of ordinary skill in the art would have reasonably expected Clement’s bacterial delivery system to transform the callus cells and modify the target nucleic acid, thereby producing transformed and modified organogenic callus.
Therefore, claims 16 and 17 would have been obvious over Feeney, Matand, Chung and Clement.
Response to Applicant’s Remarks:
Applicants’ arguments have been fully considered but are not persuasive. The present rejection no longer relies on Matt or Shestibratov for the limitations. Matand teaches wounded stem explants cultured with 5 or 10 mg/L TDZ, and Chung teaches that darkness favors TDZ-mediated callus induction. Thus, the combination teaches the amended limitations of claim 1 and provides a reason to combine them with a reasonable expectation of success.
Regarding claim 12, Otani teaches 100% nodular-callus formation from stem explants using 10 mg/L TDZ. Thus, the claimed frequency of at least about 80% would have been reasonably expected.
Regarding claim 17, the deficiencies alleged for claim 1 are addressed by Matand and Chung, while Clement teaches Agrobacterium-mediated delivery of an RNA-guided nuclease and guide RNA into plant cells. Accordingly, the arguments do not overcome the present rejections.
Conclusion
No claims are allowed.
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/YANXIN SHEN/Examiner, Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
