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 II, claims 4-10 as presently amended, in the reply filed on 6 February 2026 is acknowledged.
Claims 1-3 and 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at paragraph [0085] (20th page). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication in the Amendment to the Specification filed 20 August 2024 is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
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 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.
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.
Claims 4-10 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 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.
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 4-10 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.
Instant SEQ ID NO: 6 comprises 44 x 2 variants and instant SEQ ID NO: 7 comprises 244 variants. The number of combinations is a multiple of the two primer sequences. It is unclear what specific sequence(s) actually identify the SCD-QTL1 associated with spontaneous chromosome doubling. Hence, the metes and bounds of the claims are unclear.
Conclusion
No claims are allowed.
The claims appear to be free of the prior art. The closest prior art, acknowledged by Applicant, is Yang et al who teach maize line K22 which comprises SCD-QTLs on chromosome 7 (see Figure 1 on page 262). Applicant states that the K22 QTLs do not overlap with the SCD-QTL1 recited in the instant claims (paragraph [0095] of the instant Specification. Dawe et al teach mutating the ZmCENH3 gene to produce a haploid inducer maize plant at claim 15 (instant claim 8).
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