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 .
Claims
The amendments received on April 21, 2026, have been entered. Claims 1-8, 10, 11, 13-22, 24, and 25 are pending. Claims 3-8, 10, 14-22, 24, and 25 are withdrawn for being directed to non-elected invention. 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.
The specification defines the term “hybrid plant with a plant of the genus Petunia” as follows: “a plant originated from an intergeneric hybrid plant produced by crossing between a plant of the genus Petunia and a plant of a closely relate genus”. In light of this definition, the recitation in claim 1 of “a hybrid plant with the cytoplasmic male sterile plant of the genus Petunia” is interpreted to encompass distally related progeny of an intergeneric cross between a plant of the genus Petunia and a closely related genus. “Originated from” is defining the way an ancestor was made, but it does not limit the hybrid plant to being an F1 progeny of such a cross.
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. Applicant’s arguments were fully considered but were not found to be persuasive.
Claim 1 is the following:
A cytoplasmic male sterile plant of the genus Petunia, a progeny of the cytoplasmic male sterile plant of the genus Petunia, or a hybrid plant with the cytoplasmic male sterile plant of the genus Petunia, the cytoplasmic male sterile plant of the genus Petunia comprising
petunia nuclear genomes; and
in a mitochondrial genome thereof, a DNA molecule originated from a mitochondrial genome of a tobacco plant
wherein the DNA molecule originated from the mitochondrial genome of the tobacco plant is configured to make the plant of the genus Petunia male sterile.
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.
In the amendments received on April 21, 2026, Applicant added the requirement that “the cytoplasmic male sterile plant of the genus Petunia comprising petunia nuclear genomes;”. It is unclear if the progeny or hybrid plant are required to comprise “petunia nuclear genomes”. It is also unclear why “genomes” is plural. Are there multiple petunia nuclear genomes? Are they referring to the ploidy of the male sterile plant?
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 also unclear if the progeny or hybrid plant are required to have this DNA in the mitochondrial genome or if only the male sterile plant of the genus Petunia is required to have the DNA in the mitochondrial genome.
In the amendments received on April 21, 2026, Applicant amended claim 1 to require “wherein the DNA molecule originated from the mitochondrial genome of the tobacco plant is configured to make the plant of the genus Petunia male sterile”. It is unclear what is meant by “configured to make the plant of the genus Petunia male sterile”. What does “configured to” mean? Does this mean using a particular promoter and/or coding sequence? Does this mean cloning DNA in a particular orientation? How is a DNA “configured”?
For claim 13, it is unclear if the claim is directed to a mitochondrial genome or if the claim is directed to a plant body or seed of 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 body or seed as an intended use, or the claim could be encompassing a petunia plant body or seed containing the mitochondrial genome inside it.
Applicant argues that there is a definition for a “hybrid plant with a plant of the genus Petunia” in the specification (Resp. 9-10). The Examiner agrees, and the portion of the indefiniteness rejection that was specifically directed to this issue has been withdrawn (see claim interpretation, above).
Applicant argues that the amendments to claim 1 and 13 address the Examiner’s concerns (Resp 9). This is not persuasive. The amendments did not remove the rejections that are set forth, above.
Written Description – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 11, and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. All dependent claims are included in this rejection.
Claim 1 has been amended to recite “wherein the DNA molecule originated from the mitochondrial genome of the tobacco plant is configured to make the plant of the genus Petunia male sterile”. There is no support in the originally filed specification, abstract, or claims to support the recitation of “configured to make”. The word “configured” does not appear anywhere in the originally filed application. Nor do the working examples support any DNA being “configured” in any particular way. For this reason there is neither ipsis verbis support nor conceptual support for a DNA molecule that has been configured to make a plant male sterile.
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, a progeny of the cytoplasmic male sterile plant of the genus Petunia, or a hybrid plant with the cytoplasmic male sterile plant of the genus Petunia, the cytoplasmic male sterile plant of the genus Petunia comprising
petunia nuclear genomes; and
in a mitochondrial genome thereof, a DNA molecule originated from a mitochondrial genome of a tobacco plant
wherein the DNA molecule originated from the mitochondrial genome of the tobacco plant is configured to make the plant of the genus Petunia male sterile.” 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 progeny of the cytoplasmic male sterile petunia plant 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.
Applicant’s arguments were fully considered but were not found to be persuasive. Applicant argues that the claimed progeny includes in it’s mitochondrial genome a DNA molecule originated from a mitochondrial genome of a tobacco plant wherein the DNA molecule is configured to make the plant of the genus Petunia male sterile (Resp 11). This is not persuasive however, for two reasons: 1) it is unclear if the limitation on the mitochondrial genome applies to the progeny and/or hybrid plant or if it is only required to apply to the cytoplasmic male sterile plant of the genus Petunia; and 2) it is unclear what is meant by “configured to make the plant of the genus Petunia male sterile”. Because it is unclear what structure is required to be “configured” as required by the claim, this does not provide a limitation that distinguishes over a wild type plant.
Applicant argues that claim 13 has been amended to recite “a mitochondrial genome found in a plant body or a seed of the cytoplasmic male sterile plant of the genus Petunia” and thus should exclude wild-type CMS petunia plants (Resp 11). This is not persuasive, however, because as discussed in the indefiniteness rejection, it is unclear if the “found in a plant body or a seed” limitation is merely an intended use. If Applicant’s intent is to claim a plant body or a plant seed comprising a specific mitochondrial genome in it, then Applicant should amend the claim accordingly such that the preamble is directed to a plant body or seed.
Applicant points to Tables 3-6 and Example 1; however, this is not germane to the claims because the claims do not require any of these specifics.
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). Applicant’s arguments in the response received on April 21, 2026, have been fully considered but were not found to be persuasive.
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).
Applicant argues that Izhar fails to disclose all elements recited in amended claim 1 and that the claims have been amended to exclude a wild-type plant or mitochondria (Resp 12). This is not persuasive, however, because it is unclear if the progeny and/or hybrid plants encompassed by the claims are required to have the recited petunia nuclear genomes and/or the recited DNA molecule in the mitochondrial genome.
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). Applicant’s arguments in the response received on April 21, 2026, have been fully considered but were not found to be persuasive.
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.
Applicant argues that Nikova fails to disclose all elements recited in amended claim 13 and that the claims have been amended to exclude a wild-type plant or mitochondria (Resp 12). This is not persuasive, however, because it is unclear if the claimed mitochondrial genome must be in a plant body or seed of the genus Petunia.
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). Applicant’s arguments in the response received on April 21, 2026, have been fully considered but were not found to be persuasive.
The claims are directed to a cytoplasmic male sterile plant of the genus Petunia, a progeny of the cytoplasmic male sterile plant of the genus Petunia, or a hybrid plant with the cytoplasmic male sterile plant of the genus Petunia, the cytoplasmic male sterile plant of the genus Petunia comprising
petunia nuclear genomes; and
in a mitochondrial genome thereof, a DNA molecule originated from a mitochondrial genome of a tobacco plant
wherein the DNA molecule originated from the mitochondrial genome of the tobacco plant is configured to make the plant of the genus Petunia male sterile (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 found in a body or seed of 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 having 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.
Applicant argues that the cited references do not disclose that cell-to-cell movement of mitochondrial DNA from tobacco to Petunia is possible or that mitochondrial transfer between different genera is possible (Resp 13). Maliga specifically claims this, therefore, they expect this to be possible. In addition, Applicant provided a reference by Dragoeva with the IDS submitted on Jan. 3, 2025. Dragoeva teaches hybrid mitochondria achieved by protoplast fusions between tobacco and petunia (Dragoeva 68) and this demonstrates that it is possible to transfer mitochondrial DNA between different genera via recombination between the two types of mitochondria.
Applicant argues that Sigeno did not succeed in transferring tobacco mitochondria into a petunia nor express CMS therein (Resp 13-14). The Examiner agrees. This is why the rejection is not under 35 USC 102.
Applicant argues that Maliga did not actually reduce to practice the transfer of CMS mitochondrial DNA from tobacco to tomato (Resp 15).
Applicant argues that the transfer of mitochondrial between N. sylvestris and N. tabacum that was reduced to practice by Maliga resulted in restoring fertility to male sterile plants rather than resulting in causing male sterility; and Applicant argues that this merely discloses mitochondrial transfer which is irrelevant to CMS (Resp 15-16). This is not persuasive, however, because mitochondrial transfer is definitely relevant to CMS if the particular CMS is a trait carried in the mitochondrial genome.
Applicant argues that Maliga provided other prophetic Examples that were not reduced to practice (Resp 16). This is not persuasive, however, because there is no requirement that the prior art actually reduce to practice things that they have clearly envisioned and contemplated at the conceptual level. It is the Examiner’s position that both protoplast fusion and grafting can be used to transfer mitochondrial genomic DNA from one plant species to another. Applicant has not taught any special method steps, no “special sauce” so-to-speak. If cells from two different plant species are fused by either method, then the mitochondria can be transferred and can even recombine with one another. Dragoeva demonstrated that as did Matibiri.
Applicant argues that Maliga did not successfully transfer the CMS trait via mitochondrial transfer and therefore their disclosure did not support their claims (Resp 17-18). This is not persuasive, however, because the rejection is based upon the combination of references and the knowledge of one of ordinary skill in the art. Matibiri teaches successful transfer of CMS between different tobacco species.
Applicant argues that Matibiri teaches transfer between plants of the same genus in contrast to the claimed invention which requires mitochondrial transfer between different genera, therefore, there would be no reasonable expectation of success (Resp 19). This is not persuasive, however, because it is clear that Maliga had an expectation that mitochondrial CMS transfer between different genera of plants would succeed. Furthermore, success was known in the prior art (Dragoeva). Lastly, the instant specification did not teach any specific techniques, method steps, or materials that were critical for achieving success.
Applicant argues that the Examiner used hindsight to use guidance in the instant specification to put together features from the different prior art references (Resp 19-20). This is not persuasive, however, because the Examiner pointed to where each of the prior art references provided motivation and particular details. The claimed plants were clearly contemplated by Maliga, and the methods to arrive at the plants were either grafting or protoplast fusion to achieve mitochondrial transfer and potential recombination between mitochondria. All of this was known in the prior art.
Applicant argues that it is difficult to conduct mitochondrial transfer between different genera (Resp 20). Applicant argues that the claimed invention cannot be derived through ordinary methods described in the cited prior art references (Id.). This is not persuasive, however, because the instant specification did not use anything other than ordinary methods known in the prior art. Applicant used protoplast fusion which is routinely performed in the prior art (Spec 15 paragraph 69). The references cited in the specification are from 1981, 1974, and 1975. There are no critical steps taught. In addition, the claims are directed to the product rather than the method of making the product. Therefore, even if the prior art teaches methods of making that are inefficient and may require selecting from a large pool of candidate fused protoplasts to arrive at one that was successful in transferring the CMS trait, as long as one could succeed in generating one of these successful CMS transfers, then that is all that is required for the claimed products.
Applicant argues that the Office did not adequately evaluate the inherent difficulties of intergeneric cytoplasmic introduction, the need for multiple asymmetric cell fusions, the long-term repetition of backcrossing and selection, and the advanced recombination and stabilization of the mitochondrial genome (Resp 20). This is not persuasive, because none of these are required by the instant claims. The claims under examination are the plants; they are not methods of making such plants.
Summary
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
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