DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5 March 2026 has been entered.
Claims 1-17 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The objection to claim 17 is withdrawn in light of Applicant’s amendment to the claim.
The rejection of claim 9 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendment to the claim.
The rejection of claim 9 under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Burkett (2016, US 9,648,816) is withdrawn in light of Applicant’s amendment to the claim.
Claim Rejections - 35 USC § 112
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 the second paragraph of 35 U.S.C. 112:
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 12-13 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claim 12 is indefinite in its recitation of “An onion plant of onion hybrid SVNS7044 … further comprising a single locus conversion”.
It is not clear if the plant of claim 12 has the single locus conversion and otherwise all the morphological and physiological characteristics of SVNS7044 or
Because the plant of claim 12 is of onion hybrid SVNS7044, they must have the single locus conversion and otherwise all the morphological and physiological characteristics of SVNS7044 or if variation in the morphological and physiological characteristics are permitted.
¶40 states
“The term single locus converted plant as used herein refers to those onion plants which are developed by a plant breeding technique called backcrossing or by genetic engineering, wherein essentially all of the desired physiological and morphological characteristics of a variety are recovered or conserved in addition to the single locus introduced into the variety via the backcrossing or genetic engineering technique, respectively. By essentially all of the morphological and physiological characteristics, it is meant that the characteristics of a plant are recovered or conserved that are otherwise present when compared in the same environment, other than an occasional variant trait that might arise during backcrossing, introduction of a transgene, or application of a genetic engineering technique.
By this definition, it appears that the plant of claim 12 encompasses a genus of plants that differ from onion hybrid SVNS704 in more than just a single locus conversion.
It is not clear how much variation is encompassed by this claim. The boundary between a plant encompassed by the claim and a plant that is one morphological and physiological characteristic outside the claim is not defined. Thus, the metes and bounds of the claim are unclear.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 12-13 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The rejection is modified from the rejection set forth in the Office action mailed 6 November 2025. Applicant’s arguments filed 5 March 2026 have been fully considered but they are not persuasive.
Claim 12 is drawn to an onion plant of onion hybrid SVNS7044, further comprising a single locus conversion. As discussed in the indefiniteness rejection above, and incorporated herein, it is not clear how many variations in morphological and physiological characteristics beyond that conferred by the single locus conversion are encompassed by the claim.
Dependent claim 13 recites traits conferred by the single locus conversions.
The specification teaches that among other methods, single locus converted plants are produced by backcrossing (¶40), where the original variety of interest is used as a recurrent parent (¶42).
Producing by backcrossing a plant that comprises single locus conversion and otherwise has “essentially all of the morphological and physiological characteristics” of the original plant (¶40) requires several generations of backcrossing the single locus converted plant to eliminate off-types and plants that do not otherwise have all the morphological and physiological characteristics of the original plant.
Thus, producing plants of onion hybrid SVNS7044 with a single locus conversion requires crossing SVNS7044 plants.
SVNS7044 is a hybrid produced by crossing onion line SRL-75-4854A and onion line SRL-75-1783C (¶30). When pollen and ovules are produced from SVNS7044, a mixture of gametes that will all differ from one another are produced. None will have all the genetics of SVNS7044. When a hybrid is crossed to itself or another plant, crossing over will occur, producing a mixture of gametes that will all differ from one another. The seeds produced when these gametes join with one another will not have all the genetics of SVNS7044.
Producing a plant with the single locus conversion and otherwise “essentially all” of the morphological and physiological characteristics of SVNS7044 thus requires that the single locus conversion be backcrossed into a parent of SVNS7044, presuming it is an inbred, until a plant is produced with the single locus conversion and otherwise all the morphological and physiological characteristics of the parent. Then the SVNS7044 plant with a single locus conversion is produced by crossing the parent plant with the single locus conversion and otherwise “essentially all” of the morphological and physiological characteristics of the parent with the other parent plant.
Thus, claims 12-13 require the parents of SVNS7044, SRL-75-4854A and SRL-75-1783C, to be enabled. However, neither SRL-75-4854A nor SRL-75-1783C are publically available.
Claims 12-13 can be enabled if seeds of the parents of SVNS7044 are deposited according to 37 CFR 1.801 - 1.809.
If the deposit of these seeds is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 2500 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Response to Arguments
Applicant urges that Cardi teaches that a single locus conversion can be precisely targeted by genome editing methods (response pg 10-11).
This is not found persuasive.
Although the specification states that single locus conversions can be produced by mutation, gene editing or transformation, it also states that they can be produced by backcrossing (¶14). See also ¶40, which states
“The term single locus converted plant as used herein refers to those onion plants which are developed by a plant breeding technique called backcrossing or by genetic engineering, wherein essentially all of the desired physiological and morphological characteristics of a variety are recovered or conserved in addition to the single locus introduced into the variety via the backcrossing or genetic engineering technique, respectively. By essentially all of the morphological and physiological characteristics, it is meant that the characteristics of a plant are recovered or conserved that are otherwise present when compared in the same environment, other than an occasional variant trait that might arise during backcrossing, introduction of a transgene, or application of a genetic engineering technique.
The plants of claims 12-13 encompass those produced by introducing the single locus conversion into one or both parents, by backcrossing, mutation, gene editing or transformation, and crossing those parents to produce the claimed plant. Plants produced by such methods are not excluded by the claim and are not enabled without deposit of the parents.
Cardi does not address the backcrossing method encompassed by the claims.
The previous rejection over claims 9-11 was overcome by Laforest et al, Veillet et al, Zheng et al and Cardi et al.
Claims 1-11 and 14-17 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
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/Anne Kubelik/Primary Examiner, Art Unit 1663