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
Applicant’s election without traverse of Group I in the reply filed on 5 March 2026 is acknowledged.
Claims 12-13 and 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5 March 2026.
Claim Status
Claims 1-16 are pending.
Claims 12-13 and 15-16 are withdrawn from consideration.
Claims 1-11 and 14 are examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers filed 22 July 2024 required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities: Line 32 page 1 recites, “fast majority” when it clearly was intended to recite, “vast majority.”
Appropriate correction is required.
The disclosure is objected to because of the following informalities: Lines 3-4 page 5 and line 25 page 6 recite, “agro-cultural” when it clearly was intended to recite, “agricultural.”
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.
Claims 1-11 and 14 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 pre-AIA the applicant regards as the invention.
Claims 1 and 14 recite, “seed plant.” The specification provides the following definition:
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It is unclear if a sterile interspecific hybrid that does not bear seeds under standard growth conditions, but whose parents typically do bear seeds is considered a “seed plant.” This also raises the question of, “If the treatment of an interspecific hybrid results in it setting seed, is that typically sterile plant, now considered a “seed plant?” Given that the answers to these scenarios are unclear, the metes and bounds of the claims cannot be determined. Claims 2-11 are rejected for depending from an indefinite claim and failing to recite additional limitations that would render the claim definite.
All claims directly or indirectly recite, “plant” or “plant part.” Claim 4 recites, “interspecific hybrid.” Claims 6 and 7 recite “inflorescence.” The definitions for these words provided in the specification (screen captures below) all recite the word “preferably” in the explicit definitions of these words. It is not clear how the content of the phrase “preferably” should be weighted in interpreting the term in the claims. On one hand, a person of ordinary skill could interpret the term “preferably” to mean “optionally.” However, most people of ordinary skill in the art would conclude that “preferably” means more desirable that something that is optional. It is unclear how something that is more desirable than optional but not strictly required limits the scope of the claims. As such, the metes and bounds of the claims cannot be determined.
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Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 recites, “wherein the improved viability (antecedent basis to claim 1) of a plant pollen increases plant fertility.” The improved pollen viability itself can be considered a form of plant fertility, so the additional recitation in claim 3 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Lack of Written Description
The following is a quotation 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.
Claims 1, 3-11, and 14 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to methods of improving viability of plant pollen by treating at least part of the plant with an inhibitor of the MRN-ATM pathway. There are no structural limitations on the means of inhibiting the MRN-ATM pathway nor are there any limitations as to which component(s) of the MRN-ATM pathway are targeted.
The instant disclosure describes improving pollen viability of the F1 interspecific hybrid produced from a cross of Brassica rapa and Brassica oleracea. This improvement is achieved by treating immature flowers with Mirin (an inhibitor of the MRN-ATM pathway) which results in the anthers opening. Typically, this cross is infertile as its anthers do not open without the Mirin treatment (Figure legends and Examples). Dupre et al 2008 (Nature Chemical Biology 4:2, p. 119-125) prevents MRN-dependent activation of ATM, inhibits Mre11 activity, and abolishes the g2/M checkpoint and HDR. While this mechanism of action for Mirin was conducted in animal cells, a person of skill in the art would expect the mechanism of action to be similar in plants as cellular machinery of DNA repair and cell cycle regulation tends to be highly conserved across eukaryotes.
These descriptions are insufficient, because only a single inhibitor that has been identified as having multiple cellular targets was described as improving pollen viability. It was not described in the instant disclosure nor in the prior art what specific inhibition in a complex pathway leads to the improved fertility. The understanding of this discovery is further complicated by the teachings of Puizina et al 2004 (The Plant Cell 16: p. 1968-1978) who found that Arabidopsis mutants lacking Mre11 are infertile due to what is speculated to be genome fragmentation.
Given the broad scope of the claimed genus, the lack of working examples and the failure to describe the structures required to confer the claimed function, one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Scope of Enablement
Claims 1-11 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for using the method to improve viability of pollen in infertile interspecific hybrids, does not reasonably provide enablement for any plant of normal fertility or infertile plants that are not interspecific hybrids. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
The claims are broadly drawn to methods of improving pollen viability of any plant including plants of normal fertility or infertile plants that are not interspecific hybrids.
Applicants teach improving pollen viability of the F1 interspecific hybrid produced from a cross of Brassica rapa and Brassica oleracea. This improvement is achieved by treating immature flowers with Mirin (an inhibitor of the MRN-ATM pathway) which results in the anthers opening. Typically, this cross is infertile as its anthers do not open without the Mirin treatment (Figure legends and Examples).
Applicants do not teach how to use the claimed methods to increase pollen viability of any plant of normal fertility or infertile plants that are not interspecific hybrids.
The state-of-the-art is such that one of skill in the art cannot predict whether any improvement in fertility can be achieved in plants that are not interspecific hybrid with reduced fertility. The art regarding the effect of Mirin or any other inhibitor of the MRN-ATM pathway on flowering is sparse. The original discovery of the effects of Mirin on the MRN-ATM pathway was conducted in animal cells. Dupre et al 2008 (Nature Chemical Biology 4:2, p. 119-125) prevents MRN-dependent activation of ATM, inhibits Mre11 activity, and abolishes the g2/M checkpoint and HDR. Puizina et al 2004 (The Plant Cell 16: p. 1968-1978) teach that Arabidopsis mutants lacking Mre11 are infertile due to what is speculated to be genome fragmentation. Given that lack of Mre11 activity leads to infertility, yet treatment of typically infertile with an inhibitor of Mre11 leads to improved fertility, a person of skill in the art would find recognize attempts to improve pollen viability by inhibiting the MRN-ATM pathway as highly unpredictable.
Given the lack of guidance in the instant specification, undue trial and error experimentation would have been required for one of ordinary skill in the art to use the claimed methods within the broad scope of the claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663