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 .
Election/Restrictions
In the response received on Sept. 30, 2025, Applicant elected Group I, claims 1, 2, 11, and 13, with traverse. Claims 3-8, 10, 14-22, 24, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on Sept. 30, 2025.
Applicant traverses based on the following arguments:
Applicant argues that the cited references do not disclose that cell-to-cell movement of mitochondrial DNA from tobacco to Petunia is possible nor that mitochondrial transfer between different genera is possible, nor do the references experimentally confirm that a CMS plant of the genus Petunia is produced (Resp 2).
This is not persuasive, however, because Maliga showed that cytoplasmic male sterile (CMS) plants were obtained from their graft between CMS N. sylvestris root stock and N. tabacum graft partner (Maliga 9 ¶¶ 75-75). The resulting CMS plants contained the N. tabacum nuclear genome with the N. sylvestris plastid genome and recombined mitochondria with mitochondrial DNA from both parent plants (Id. ¶¶ 77-78). This is evidence of cell-to-cell movement of mitochondrial DNA through the graft junction.
With regard to mitochondrial transfer between different genera, Sigeno clearly teaches the transfer of chloroplasts from tobacco into petunia which are two different genera. In the information disclosure statement (IDS) received on Jan. 3, 2025, Applicant provided a reference by Dragoeva et al ((1999) Plant Cell, Tissue, and Organ Culture; Vol. 55; pp. 67-70) that teaches hybrid mitochondria achieved by protoplast fusions between tobacco and petunia (Dragoeva 68). This demonstrates that it is possible to transfer mitochondrial DNA between different genera via recombination between the two types of mitochondria.
With regard to confirming a CMS plant of the genus petunia being produced, this was not reduced to practice by Maliga; it was suggested and claimed. Without reducing to practice, there is no way to experimentally confirm the result.
Applicant points out that Maliga’s experiments between N. sylvestris and N. tabacum were to restore fertility rather than to cause CMS (Resp 3-4). The Examiner agrees, however, this experiment showed success in transferring mitochondria from the root stock into the cells of the grafted scion, and this experiment also showed the resulting recombination between the two types of mitochondria.
Applicant points out that Maliga’s example 2 about grafting petunia and tomato was written in present tense and was not reduced to practice (Resp 4). The Examiner agrees, however, this is not persuasive, because there is no legal requirement that the prior art have an actual reduction to practice for everything they contemplate, envision, or claim.
Applicant argues that in Maliga’s Example 4 they teach that none of the three plants generated from that experiment had any mitochondrial DNA transferred (Resp 4-5). This is not persuasive, however, because Maliga follows this information with the following: “Although we did not find evidence for the co-transfer of mtDNA transfer with ptDNA in the lines tested, it is possible that mtDNA transfer could be detected in a larger PGT plant population”.
Applicant argues that the end of the Examples in Maliga do not state any procedure for intercellular transfer of the mitochondrial genome (Resp 5). The Examiner agrees that the last paragraphs of Maliga are directed more to plastid transfer rather than mitochondrial transfer. Maliga did posit that the lack of a selectable marker for the mitochondrial trait likely led to the loss of mitochondria that were co-transferred with the plastids, and Maliga suggests testing a larger population of plants could possible yield plants expressing the CMS flower morphology. Maliga suggests using a dominant mitochondrial trait to increase the likelihood of detecting the co-transfer of mitochondria (Maliga 13 ¶ 100).
Applicant argues that Maliga is not enabling for producing cytoplasmic male sterile plants (Resp 5). This is not persuasive, however, because Maliga clearly teaches recombination between mitochondrial genomes, and if the root stock had been CMS and the scion had been fertile, then the opposite result would have been achieved. It is clear that Maliga claims transfer of the CMS mitochondrial trait via cell fusion or grafting (Maliga, claim 1). Both protoplast fusion and grafting were well-known and routine in the art at the time of filing and at the time of Maliga’s filing. There is no requirement for a patent application to include details of well-known techniques to be enabling.
Applicant argues that Sigeno transferred tobacco chloroplasts into petunia but did not transfer tobacco mitochondria into petunia, and Sigeno does not suggest or motivate one to transfer CMS-producing mitochondria from tobacco into Petunia (Resp 6). The Examiner agrees, however, the combination of Maliga and Sigeno taken together teach all of the limitations for the instant claim 1. Sigeno is relied upon to specifically teach transferring organelles from tobacco into petunia and for teaching protoplast fusion with more specificity to complement Maliga’s focus on grafting. It is the Examiner’s understanding of the art that both protoplast fusion AND grafting can be used to transfer mitochondrial genomic DNA from one plant species to another.
For these reasons, the instant claims lack unity of invention and the lack of unity is further reinforced by the art rejections in the current Office Action, see below.
The restriction requirement is maintained with the understanding that should any claim be found allowable, then all claims that require all limitations of the allowable claim will be rejoined. Claims 1-8, 10, 11, 13-22, 24, and 25 are pending. Claims 1, 2, 11, and 13 are examined in this Office Action.
Claim Interpretation
The claims encompass “progeny thereof”, and this is not limited to immediate next generation plants (F1s). Instead, it is inclusive of many generations removed. The current claim language does not require the “progeny thereof” to retain cytoplasmic male sterility (CMS), nor does it require the “progeny thereof” to retain the DNA molecule. Therefore, the claim is broad enough to include progeny that have lost the CMS trait and the tobacco mitochondrial DNA.
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.
Claims 1, 2, 11, and 13 are 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Claim 1 is the following:
A cytoplasmic male sterile plant of the genus Petunia comprising, in a mitochondrial genome thereof, a DNA molecule originated from a mitochondrial genome of a tobacco plant, or a hybrid plant with the cytoplasmic male sterile plant of the genus Petunia, or a progeny thereof.
It is unclear what scope is covered by “plant of the genus Petunia”. A reading of the specification shows that Applicant made protoplast fusions between petunia protoplasts and tobacco protoplasts (Spec 19-21), resulting in both diploid and tetraploid cytoplasm hybrid plants (Id. 21 ¶ 97). The tetraploid plants likely contained both the tobacco and the petunia nuclear genomes, as evidenced by Pental et al ((1986) Mol Gen Genet; Vol 202; pp. 342-347). Pental made protoplast fusions between petunia and tobacco and showed that initially the fused cells contained both tobacco and petunia nuclear genomes, but with culturing over time most of the fusions lost the tobacco genome (Pental 343-344, Figure 1). It is unclear if the claimed “plant of the genus Petunia” is required to contain only the petunia nuclear genome, or if a plant that comprises both nuclear genomes would be covered by the current claims. Does a plant have to look like a petunia by having petunia morphology (Pental 345 Figure 4)? Would a plant having an intermediate morphology qualify as a petunia? The metes and bounds of the claim are not clear.
It is unclear how one of skill in the art can determine if any particular DNA molecule “originated from a mitochondrial genome of a tobacco plant”. This recitation is inclusive of very small pieces of DNA, such as “ATG” (most common start codon). If any given CMS plant of the genus Petunia has an “ATG” in its mitochondrial genome, is it infringing? There is no minimum size for the required DNA molecule.
It is unclear what is meant by “a hybrid plant with the cytoplasmic male sterile plant of the genus Petunia”. Does this mean a hybrid plant standing side-by-side with the CMS plant of the genus Petunia? Does this mean an F1 progeny of a cross between the CMS plant and a different plant? Does this encompass tetraploid plants containing both tobacco and petunia DNA (intergeneric hybrids)? Or is the recitation “or a hybrid plant with the cytoplasmic male sterile plant of the genus Petunia” mean that the DNA molecule can originate from this hybrid plant?
It is unclear what the “progeny thereof” is referring to. Is the “progeny thereof” a source for the recited DNA molecule? Or is the claim including a progeny of the plant recited in line 1?
For claim 13, it is unclear if the claim is directed to a mitochondrial genome or if the claim is directed to a plant of the genus Petunia that contains a mitochondrial genome. The claim could be limited to a mitochondrial genome with the idea of being contained in the petunia plant as an intended use, or the claim could be encompassing a petunia plant containing the mitochondrial genome inside it.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 11, and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature without significantly more. The claim(s) recite(s) “A cytoplasmic male sterile plant of the genus Petunia comprising, in a mitochondrial genome thereof, a DNA molecule originated from a mitochondrial genome of a tobacco plant, or a hybrid plant with the cytoplasmic male sterile plant of the genus Petunia, or a progeny thereof.” The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for multiple reasons:
including “or progeny thereof” does not require the petunia progeny to retain the mitochondrial DNA from tobacco, therefore this includes wild-type CMS petunia plants which are products of nature.
As discussed, above, in the indefiniteness rejection, a small DNA molecule from a tobacco mitochondria is no different than a small DNA molecule from a petunia mitochondria, therefore, the source of the recited DNA molecule does not provide a structural limitation that amounts to significantly more than a wild-type CMS petunia plant with its own mitochondrial genome.
With regard to claim 13, specifically, a mitochondrial genome comprising a DNA molecule from a tobacco mitochondria could be a wild-type tobacco mitochondria which is a product of nature.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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.
Claim(s) 1, 2, 11, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Izhar, S. ((1972) HortScience; Vol. 7; p. 555).
As discussed, above, in the rejection under 35 USC 101, the claims read on a wild-type CMS petunia plant. Izhar teaches wild CMS petunia plants (right column).
Claim(s) 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nikova et al. ((1997) Euphytica; Vol. 94; pp. 375-378).
As discussed, above, in the rejections under 35 USC 101 and 35 USC 112, this claim reads on a CMS tobacco mitochondria. Nikova teaches three different Nicotiana species with CMS genes (Nikova 375, materials and methods). These tobacco plants inherently comprise mitochondrial genomes conferring the CMS trait.
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.
Claim(s) 1, 2, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sigeno et al. ((2009) Vol. 28; pp. 1633-1640) in view of Maliga et al (US Pre-Grant Publication US 2016/0272981 A1, published on Sept. 22, 2016), and further in view of Matibiri et al. ((1994) Theor Appl Genet; Vol. 88; pp. 1017-1022).
The claims are directed to a cytoplasmic male sterile plant of the genus Petunia comprising, in a mitochondrial genome thereof, a DNA molecule originated from a mitochondrial genome of a tobacco plant, or a hybrid plant with the cytoplasmic male sterile plant of the genus Petunia, or a progeny thereof (claim 1), including wherein the tobacco plant source for the mitochondrial DNA is Nicotiana suaveolens (claim 2), and to plant parts or seeds of said plant (claim 11), and to a mitochondrial genome contained in said plant (claim 13).
This rejection is based on the interpretation of the claims that requires the CMS plant to have petunia morphology and a CMS gene in its mitochondria wherein at least a part of the CMS gene came from tobacco. As discussed, above, in the indefiniteness rejections, the current claim language does not require these narrow embodiments, however, the Examiner was looking for art as close to the Applicant’s working example as possible.
Sigeno teaches somatic “cybrids” made from fusing tobacco and petunia protoplasts (Sigeno 1634). Sigeno teaches selecting the cybrids with petunia characteristics for regeneration (Id.). Sigeno teaches obtaining 5 regenerated plants with petunia morphology, RAPD marker patterns of petunia nuclear DNA and markers for tobacco chloroplast DNA (Id. 1636-1637).
Sigeno does not teach tobacco mitochondria between transferred into the cybrids with petunia morphology and petunia nuclear genomes.
For claim 2, specifically, Sigeno does not teach Nicotiana suaveolens.
Maliga teaches that a source of mitochondrial DNA that confers male sterility is male sterile tobacco (Maliga 4 ¶ 28). Maliga claims transferring the mitochondria from a male sterile tobacco plant to a fertile plant via grafting and selecting for shoots comprising the transferred mitochondrial gene transfer (Id. 90, claim 1). Maliga specifies that the plant receiving the male sterility mitochondrial DNA is a tomato, brassica, carrot, soybean, common bean, maize, pepper, petunia, radish, rice, sorghum, sugar beet, sunflower, tobacco, or wheat (Id. claim 2). Maliga claims joining cells of two plants to effect intercellular transfer of organelles (Id. claim 11). Maliga teaches the desirability of the CMS trait in crops that utilize hybrid seed to avoid the labor-intensive removal of anthers from the flowers that will be receiving pollen (maternal flowers) (Id. 4 ¶ 28).
Matibiri teaches protoplast fusions between Nicotiana suaveolens and Nicotiana tabacum to arrive at cybrids, including cybrids with the CMS trait from N. suaveolens (Matibiri 1017). Matibiri teach that out of a total of 44 regenerated plants, 4 CMS plants were obtained (Id.). These male sterile plants were pollinated with N. tabacum pollen for seed collection (1020).
At the time the instant application was filed, it would have been obvious and within the scope of one of ordinary skill in the art to modify the teachings of Sigeno to utilize a CMS tobacco plant, such as the N. suaveolens plant taught by Matibiri. One would have been motivated to do so because Maliga teaches that have the CMS trait is desirable for producing hybrid seeds. Maliga specifically claims transferring the CMS trait from tobacco into petunia. One would have expected to succeed in transferring a tobacco-sourced CMS trait from N. suaveolens into petunia because Matibiri teaches success in using N. suaveolens as a donor of mitochondria comprising the CMS trait.
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663