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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 April 2026 has been entered.
Claims 17-19, 23-24, and 31-32 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 .
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 17-19, 23-24, and 31-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 16 January 2026. Applicant’s arguments filed 16 April 2026 have been fully considered but they are not persuasive.
Claim 17 recites a method of identifying a maize plant by isolating a nucleic acid from a maize plant and detecting at least one molecular marker linked to an allele on chromosome 5 corresponding to G at position 159121201. This judicial exception is not integrated into a practical application. This is a judicial exception because, while an allele on chromosome 5 corresponding to G at position 159121201 in maize genomic DNA was not known in the prior art, its discovery and the discovery of the region’s relationship to increased yield under drought conditions is merely the discovery of a natural phenomenon.
The correlation between the presence or absence of a marker linked to an allele on chromosome 5 corresponding to G at position 159121201 in maize genomic DNA exists in nature apart from human detection or the methods used to detect them, as this relationship would exist in wild maize, teosinte.
The claim recites the additional element that a maize plant is selected with marker SM2973. However, selection of a plant is a mental process.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. This a judicial exception is not integrated into a practical application because the claim does not recite any further steps that make use of the discovery in a specific, nonnaturally-occurring manner. The claims do not, for example, recite an nonmental action performed after selection of a plant with the marker that is not performed after selection of a plant that lacks the marker, or vice versa.
Thus, claim 17 is not drawn to significantly more than identifying a natural phenomenon.
Claims 18-19, dependent upon claim 17, recite the additional element of the localization of the marker to a chromosomal interval. However, these recitations are merely directed to where the marker is positioned on the chromosome and do not integrate the judicial exception into a practical application. Thus, these claims are not drawn to significantly more than identifying a natural phenomenon.
Claim 31, dependent upon claim 17, recites the additional element of the primer pair or probe used in the detection. However, this recitation is merely directed to the identity of the primer or probe used in the method of identifying a natural phenomenon and does not integrate the judicial exception into a practical application. Thus, this claim is not drawn to significantly more than identifying a natural phenomenon.
Claim 32, dependent upon claim 17, recites the additional element that the molecular marker is a SNP, QTL, AFLP, RAPD, RFLP, or microsatellite. However, this recitation is merely directed to nature of the molecular marker used in the method of identifying a natural phenomenon and does not integrate the judicial exception into a practical application. Thus, this claim is not drawn to significantly more than identifying a natural phenomenon.
Claim 23, recites the additional elements of how the detecting is carried out and the positions of informative fragments generated by the detecting method; dependent claim 24 recites a specific informative fragment. This recitation of the how the detecting is carried out and the positions of informative fragments generated by the detecting method is not a recitation any further steps that make use of the discovery in a specific, nonnaturally-occurring manner.
Thus, these claims are not drawn to significantly more than identifying a natural phenomenon.
Response to Arguments
Applicant urges that isolating a nucleic acid from a plant and detecting a molecular marker occurs in the physical world and is significantly more than a natural phenomenon (response pg 1).
This is not found persuasive. This is a judicial exception because, while an allele on chromosome 5 corresponding to G at position 159121201 in maize genomic DNA was not known in the prior art, its discovery and the discovery of the relationship of an allele on chromosome 5 corresponding to G at position 159121201 to increased yield under drought conditions is merely the discovery of a natural phenomenon. Detecting that allele in another plant is merely repeating that discovery. Selecting a plant with the marker is merely a mental process. There are no elements of the claims that integrate the judicial exception into a practical application. Or example, the claims do nothing with plants that have that allele that is not done with plants that do not. This is similar to the situations in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013), Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1375, 118 USPQ2d 1541, 1545 (Fed. Cir. 2016), and Ariosa Diagnostics, Inc. v. Sequenom, 788 F.3d 1371, 1373, 115 USPQ2d 1152, 1153 (Fed. Cir. 2015). See MPEP 2106.04(b)I.
Claim Rejections - 35 USC § 112
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 17-19, 23-24, and 31-32 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 repeated for the reasons of record as set forth in the Office action mailed 16 January 2026. Applicant’s arguments filed 16 April 2026 have been fully considered but they are not persuasive.
The claims are broadly drawn to methods comprising isolating a nucleic acid from a maize plant, detecting in a maize plant a marker allele associated with a chromosome 5 QTL, and selecting a plant with the marker.
Practicing the steps of detecting a marker allele associated this QTL and selecting a plant with the marker requires a plant with this claimed allele, which is located on maize chromosome 5 corresponding to a G allele at position 15912120.
Table 11 of the instant specification indicates that inbreds 44-202 have the claimed QTL allele in this region, and Table 12 indicates that Hybrid 1 has the claimed QTL (Hybrids 3 and 4 are indicated both has having favorable alleles and increased yield and as not having them, so it is not clear if they actually have the allele or increased yield). However, inbreds 44-202 and Hybrid 1 are merely names that do not tell one of skill in the art anything about a cultivar or hybrid with the claimed region. One of skill in the art would not even know if any of these inbreds or the hybrid are publically available.
Thus, the instant specification fails to teach any plant with the claimed chromosome 5 QTL.
It is noted that Applicant makes no assertion that any of the QTL itself is responsible for increased yield. Thus, one of skill in the art could not make a plant that can used in the method by transformation.
Because of that, one of skill in the art must use undue trial and error experimentation in an attempt to find an increased yield corn plant on which the detecting step of the claimed method can be practiced, if it even possible to do so.
Example 3 identified a gene located in this chromosomal region of the maize genome thought to be responsible for increased yield under drought conditions. This gene, SEQ ID NO:5, encodes SEQ ID NO:13. However, the claims are not interpreted as reading on a plant transformed with a nucleic acid encoding SEQ ID NO:13 because claim 17 requires the assay be one where the molecular marker is within 20cM or is linked to a G allele at position 159121201 on chromosome 5. As transformation inserts transgenes at random locations in the genome, a transgene would not be linked to position 159121201 on chromosome 5 in this manner. Thus, even though a method of transforming a plant with a nucleic acid encoding SEQ ID NO:13 would be enabled, such a method is excluded by the language of the claims.
Given the claim breath and lack of guidance in the specification as discussed above, the instant invention is not enabled.
Response to Arguments
Applicant urges that one of skill in the art would know how to extract DNA and screen with the claimed marker (response pg 5).
This is not found persuasive. The rejection is not that one of skill in the art would not know how to extract DNA and screen with the claimed marker. The rejection is that the specification does not teach the starting material for the method, that is, a plant with the claimed chromosome 5 QTL, much less the full scope of them.
Applicant is reminded yet again that this rejection can be overcome by amending the specification to replace the inbreds 44-202 and Hybrid 1 terms with the actual names of inbreds and hybrids used to produce the data, and, if those plants are not publically available, depositing a representative sample of their seeds under the practice of 37 CRF 1.801 - 1.809.
Claims 17-19, 23-24, and 31-32 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 rejection is repeated for the reasons of record as set forth in the Office action mailed 16 January 2026. Applicant’s arguments filed 16 April 2026 have been fully considered but they are not persuasive.
The claims require a maize plant with a QTL linked to a G allele at position 159121201 on chromosome 5 to perform all the claimed method steps.
Table 11 of the instant specification indicates that inbreds 44-202 have the claimed QTL allele in this region, and Table 12 indicates that Hybrid 1 has the claimed QTL (Hybrids 3 and 4 are indicated both as having favorable alleles and increased yield and as not having them, so it is not clear if they actually have the allele or increased yield). However, inbreds 44-202 and Hybrid 1 are merely nonce names that do not tell one of skill in the art anything about a cultivar or hybrid with the claimed region. One of skill in the art would not even know if any of these inbreds or hybrid(s) are publically available.
The specification fails to describe any publically available plants that can be used in the claimed methods, much less the full scope of them.
It is noted that Applicant makes no assertion that any of the Table 5 alleles linked to and associated with the QTL is responsible for increased yield. Example 3 identified a gene located in this chromosomal region of the maize genome the inventors think is responsible for increased yield under drought conditions. This gene, SEQ ID NO:5, encodes SEQ ID NO:13. However, the claims are not interpreted as reading on a plant transformed with a nucleic acid encoding SEQ ID NO:13 because claim 17 requires the assay be one where the molecular marker is linked to a G allele at position 159121201 on chromosome 5. As transformation inserts transgenes at random locations in the genome, transgenes would not be linked to position 159121201 on chromosome 5 in this manner. Thus, even though a method of assaying and breeding with a plant transformed with a nucleic acid encoding SEQ ID NO:13 could be described, such a method is excluded by the language of the claims.
Because inbreds 44-202 and Hybrid 1 are not publically available, the specification does not describe any plants that can used in the method. Such a description is required. See University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004) at page 1894:
Rochester also attempts to distinguish Fiers, Lilly, and Enzo by suggesting that the holdings in those cases were limited to composition of matter claims, whereas the '850 patent is directed to a method. We agree with the district court that that is “a semantic distinction without a difference.” Univ. of Rochester, 249 F. Supp. 2d at 228. Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. As the district court observed, “[t]he claimed method depends upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment.”
Because the plants with the claimed QTL are not described, the method of using the plants is likewise not described, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the compositions used in the claimed methods, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Arguments
Applicant urges that one of skill in the art would know how to extract DNA and screen with the claimed marker (response pg 5).
This is not found persuasive because is a written description rejection, not an enablement rejection.
The specification does not describe any plants with the claimed chromosome 5 QTL associated with increased yield, and thus does not describe the starting material for the claimed method.
Applicant is reminded yet again that this rejection can be overcome by amending the specification to replace the inbreds 44-202 and Hybrid 1 terms with the actual names of inbreds and hybrids used to produce the data, and, if those plants are not publically available, depositing a representative sample of their seeds under the practice of 37 CRF 1.801 - 1.809.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 extension fee 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 date of this final action.
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
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