Status of the Application
This Office Action is in response to the Amendment and Remarks filed 6 July 2026.
The objections to the Specification are withdrawn in view of Applicant’s amendments.
The rejection under 35 U.S.C. 112(b) is withdrawn because the metes and bounds of SEQ ID NO: 6 and SEQ ID NO: 7 are defined.
Election/Restrictions
Claims 1-3 and 11-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6 February 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 112
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 4-10 remain 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.
Applicant claims a method of obtaining a spontaneously double haploid plant using a maize plant comprising SCD-QTL1 comprising SEQ ID Nos: 6 and 7 that is [are] associated with spontaneous chromosome doubling. Instant SEQ ID NO: 6 comprises 44 x 2 variants and instant SEQ ID NO: 7 comprises 244 variants.
Applicant describes maize lines SYN004 and SYN007 that produce a high percentage of fertile haploids that can undergo spontaneous chromosome doubling to produce double haploid progeny in Table 1, paragraph [0083].
Applicant does not describe any structure that produces spontaneous chromosome doubling, only the SCD-QTL1 that is “associated with spontaneous chromosome doubling”. It is unclear which variant of instant SEQ ID NO: 6 and SEQ ID NO: 7 would actually describe an association with said SCD-QTL1. Further, it is unclear if maize lines SYN004 and SYN007 would be readily available.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed.
See also, MPEP § 2163 which states that the claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
Applicant argues that the specification describes, "SCD-QTL1" refers to the presently identified QTL on chromosome 7, which "is defined by the region of chromosome 7 flanked by two markers, SM0077AQ and SM11142" and "[t]hese markers correspond to their physical locations in the B73_v4 reference genome." See paragraph [0034]. Applicant argues that two markers "flank a 2.54 Mb region (B73_v4 coordinates), containing 46 annotated gene models (pages 1-2 of the Remarks).
Applicant’s arguments are not found persuasive. Table 4 of the Specification describe marker names and B73_v4 positions on chromosome 7, Table 6 describes primers used for markers SM0077AQ and SM11142. As addressed above, the degenerate markers SM0077AQ and SM11142 do not define a structure/function relationship for the “spontaneously doubled haploid plant” phenotype.
Concerning the amendment to claim 4, the limitation “the B73_v4 reference genome” represents an improper incorporation by reference and thus the claim(s) lack proper written description. See 37 CFR 1.57(d).
Claims 4-10 remain 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 a method of obtaining a spontaneously doubled haploid plant using maize lines SYN004 and SYN007, does not reasonably provide enablement for a method of obtaining a spontaneously double haploid plant using a maize plant comprising SCD-QTL1 comprising SEQ ID Nos: 6 and 7 that is [are] associated with spontaneous chromosome doubling. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Applicant claims a method of obtaining a spontaneously double haploid plant using a maize plant comprising SCD-QTL1 comprising SEQ ID Nos: 6 and 7 that is [are] associated with spontaneous chromosome doubling. Instant SEQ ID NO: 6 comprises 44 x 2 variants and instant SEQ ID NO: 7 comprises 244 variants.
Applicant teaches maize lines SYN004 and SYN007 that produce a high percentage of fertile haploids that can undergo spontaneous chromosome doubling to produce double haploid progeny in Table 1, paragraph [0083].
Applicant does not teach any structure that produces spontaneous chromosome doubling, only the SCD-QTL1 that is “associated with spontaneous chromosome doubling”. It is unclear which variant of instant SEQ ID NO: 6 and SEQ ID NO: 7 would actually teach an association with said SCD-QTL1. Further, it is unclear if maize lines SYN004 and SYN007 would be readily available.
In re Wands, 858F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) lists eight considerations for determining whether or not undue experimentation would be necessary to practice an 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 claims.
Instant SEQ ID NO: 6 comprises 44 x 2 variants and instant SEQ ID NO: 7 comprises 244 variants. The recited sequences include a vast genus of primers and combinations thereof. It is unclear from the instant Specification what primers were used to identify the SCD-QTL1 associated with spontaneous chromosome doubling were used. In addition, it is unclear where the germplasm SYN004 and SYN007 were derived from. Hence, given the limited guidance, nature of the invention, unpredictability of the art and the breadth of the claims it would have required undue trial and error experimentation to make and use the invention as broadly claimed.
In Wyeth v. Abbott Laboratories, 107 USPQ2d 1273, at 1276-1277 (Fed. Cir. 2013), the court teaches that, the specification…discloses only a starting point for further iterative research in an unpredictable and poorly understood field, the resulting need to engage in a systematic screening process for each of the many rapamycin candidate compounds is excessive experimentation. The court thus held that there is no genuine dispute that practicing the full scope of the claims measured at the filing date, required undue experimentation.
Applicant argues that they screened 20 lines for SCD and identified lines SYN004 and SYN007 as exhibiting SCD at rates of 100% and 96%, respectively. Example 3 provides detailed fine-mapping of the QTL boundaries using SNP-based TaqMan assay markers, with Table 4 listing the specific marker locations and Table 6 providing the DNA sequences for markers SM0077AQ and SM11142 that define SCD-QTL1, including the forward primers (SEQ ID NOs: 1, 3, and 4), reverse primers (SEQ ID NOs: 2 and 5), and target sequences (SEQ ID NOs: 6 and 7). Applicant argues that Examples 6 and 7 demonstrate QTL penetrance across diverse germplasm, with Table 7 showing phenotypic data from 17 elite inbred lines representing several heterotic groups. Applicant argues that the specification, and claims as amended herein, provides the specific chromosomal location, marker boundaries, physical positions, and primer sequences necessary to identify and select for SCD-QTL1 in any maize germplasm, thereby enabling one skilled in the art to practice the claimed methods without requiring access to these specific lines (pages 2-3 of the Remarks).
Applicant’s arguments are not found persuasive. Example 1 screened lines known to have SCD (spontaneous chromosome doubling). Example 6 teaches screening backcross progeny of SYN004 (the QTL donor); hence this example uses a known line comprising the SCD-QTL1. Example 7 appears to use the same QTL donor. Applicant does not appear to teach which sequence of SEQ ID NO: 6 and SEQ ID NO: 7 are correlated with the SCD phenotype, or if identified lines SYN004 and SYN007 have different marker sequences. Further, Applicant does not teach what structure in the QTL actually produces the SCD phenotype. Hence, the rejection is maintained for the reasons of record.
Conclusion
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.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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/David H Kruse/
Primary Examiner, Art Unit 1663
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