DETAILED ACTION
Claims 1-12 and 14-20 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The objection to the specification is withdrawn in light of Applicant’s amendment.
The rejection of claims 1-20 under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Chandler et al (2019, US 10,327,402) is withdrawn in light of Applicant’s amendment to the claims and specification.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,327,402 is withdrawn in light of Applicant’s amendment to the claims and specification.
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 1-12 and 14-20 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.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 22 April 2025. Applicant’s arguments filed 22 July 2025 have been fully considered but they are not persuasive.
Claim 5 is indefinite in its recitation of “comprising the single locus conversion … having otherwise all the physiological and morphological characteristics of hybrid maize X76T002”. It is not clear what the physiological and morphological characteristics of hybrid maize X76T002 are. The specification only describes physiological and morphological characteristics of X76T002 with one or more locus conversions for insect control and/or herbicide tolerance (Table 1, “Wherein X76T002 has one or more locus conversion(s) for insect control and/or herbicide tolerance”).
The specification recites the following with respect to locus conversions:
[148] Traits may be used by those of ordinary skill in the art to characterize progeny. Traits are commonly evaluated at a significance level, such as a 1%, 5% or 10% significance level, when measured in plants grown in the same environmental conditions. For example, a locus conversion of X76T002 may be characterized as having essentially the same or essentially all of the phenotypic traits or physiological and morphological traits or characteristics as X76T002. By essentially all of the phenotypic characteristics or morphological and physiological characteristics, it is meant that all of the characteristics of a plant are recovered that are otherwise present when compared in the same environment, other than an occasional variant trait that might arise during backcrossing or direct introduction of a transgene or genetic modification. The traits used for comparison may be those traits shown in Table 1 as determined at the 5% significance level when grown under the same environmental conditions.
The definition of “essentially all of the phenotypic characteristics or morphological and physiological characteristics” above indicates that an “occasional variant” is encompassed. The specification does not indicate how an “occasional variant”, which by the use of the word “occasional” is something that happens at some times and not at other times, applies to a product, i.e., the claimed plant. The specification indicates in ¶258 that “an” reads on more or more. Given that, “an occasional variant” means one or more.
It is not clear if the locus converted X76T002 in Table 1 has the same phenotypic traits or physiological and morphological traits as X76T002 without those locus conversion(s) or if it only has “essentially all” of the phenotypic traits or physiological and morphological traits as X76T002 without those locus conversion(s); if the latter, it is not clear how many “occasional variants” are in the plant of Table 1.
Further, the discussion in ¶148 states “The traits used for comparison may be those traits shown in Table 1”. However, the traits in Table 1 are X76T002 with one or more locus conversions. As locus converted X76T002 may have only “essentially all” of the phenotypic traits or physiological and morphological traits as X76T002, the discussion of locus converted X76T002 in ¶148 indicating that comparison may be made to a locus converted X76T002 becomes circular discussion, making the claims further indefinite.
Locus conversions for insect control and herbicide resistance affect plant traits.
At least one glyphosate resistance event increases yield (See example 2 in US 6,825,400). Insect resistance genes can also affect plant traits. For example, plants infected with corn rootworms have reduced water and nutrient uptake, increased lodging, reduced yield, reduced pollination, and increased disease susceptibility (Purdue University College of Agriculture, 2025, https://ag.purdue.edu/department/entm/extension/field-crops-ipm/corn/corn-rootworms.html; see pg 4, ¶2-3); these damage effects affect numerous plant traits reported in Table 1, including yield, plant height, and ear weight. In plants comprising a locus conversion for rootworm resistance these effects would be reduced or eliminated. The locus conversion(s) used in the plant used to produce Table 1 are not specified and the plant without locus conversion(s) is not described. It is thus not clear what the physiological and morphological characteristics of X76T002 are.
It is thus not clear what the single locus conversion claimed in claim 5 is in relation to - X76T002 without locus conversions or the locus converted X76T002 as in Table 1.
It is thus also unclear what the physiological and morphological characteristics of hybrid maize X76T002 are.
Claims 1, 11, and 18 recite “representative seeds of the maize lines 1PGGG27 and PH4D62 have been deposited under NCMA Accession Numbers 202106051 and 202110057”. It is unclear how the seeds are “representative”. Even though the claims have been amended to recite that 1PGGG27 and PH4D62 are lines not varieties, it is not clear if these seeds are the ones that produced the locus converted X76T002 in Table 1 or that produce X76T002 without locus conversions. It is thus unclear in what way the deposited seeds are “representative”.
Response to Arguments
Applicant urges that “representative seed” means that the seeds deposited are representative of the claimed lines and are intended to encompass random and rare changes in the genome that occur, for example, during cellular replications, such as DNA polymerase errors (response pg 8).
This is not found persuasive. It is not clear what is in the deposits - 1PGGG27 and PH4D62 with the locus conversions used to produce the plant described in Table 1, 1PGGG27 and PH4D62 without any locus conversions, or something else. It is not clear what the physiological and morphological characteristics of X76T002 are because the specification only describes the physiological and morphological characteristics of X76T002 with an unknown number of locus conversions. Further, Applicant stated above that the deposit encompasses an unspecified number of random and rare variations; if a deposit had to be replaced, how many additional phenotypic and genetic variations would it have relative to initial deposit?
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 1-12 and 14-20 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.
Due to Applicant’s amendment of the claims, the rejection is different from the rejection set forth in the Office action mailed 22 April 2025, as applied to claims 1-20. Applicant’s arguments filed 22 July 2025 have been fully considered but they are not persuasive.
The claims all require seed of parents 1PGGG27 and PH4D62.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
Applicant has deposited seeds for parents 1PGGG27 and PH4D62 at the NCMA, but it is not clear if the deposits were made under the terms of the Budapest Treaty or not. Applicant has submitted Deposit Receipts for 1PGGG27 and PH4D62 that indicate that the deposits were accepted under the terms of the Budapest Treaty. However, amended ¶260 of the specification has no indication that the deposits were made under the terms of the Budapest Treaty. Instead, the paragraph and Applicant’s response filed 22 July 2025 both make the statements required set forth in 37 CFR 1.801-1.809 for when a deposit is not made under the Budapest Treaty.
It is thus unclear, if the deposits were made under the terms of the Budapest Treaty.
Response to Arguments
Applicant made the statements required set forth in 37 CFR 1.801-1.809 for when a deposit is not made under the Budapest Treaty (pg 10).
This is not found persuasive because the Deposit Receipts for 1PGGG27 and PH4D62 that indicate that the deposits were accepted under the terms of the Budapest Treaty. I t is thus unclear, if the deposits were made under the terms of the Budapest Treaty or not.
Claims 1-12 and 14-20 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 claims contain subject matter that 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.
Due to Applicant’s amendment of the claims, the rejection is different from the rejection set forth in the Office action mailed 22 April 2025, as applied to claims 1-20. Applicant’s arguments filed 22 July 2025 have been fully considered but they are not persuasive.
35 USC 112 requires that the specification have a written description of the invention:
35 U.S.C. 112 Specification.
(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. (emphasis added)
The instant specification fails to provide the traits of the claimed hybrid. A plant line is defined by both its genetics (i.e., its breeding history) and its traits. In the instant application, Applicant has provided the parents of X76T002, but has not provided the traits of the claimed plant. The specification only provides a description of traits of X76T002 with one or more locus conversions for insect control and/or herbicide tolerance (Table 1, “Wherein X76T002 has one or more locus conversion(s) for insect control and/or herbicide tolerance”), that is, a plant other than what is being claimed.
At least one glyphosate resistance event increases yield (See example 2 in US 6,825,400). Insect resistance genes can also affect plant traits. For example, plants infected with corn rootworms have reduced water and nutrient uptake, increased lodging, reduced yield, reduced pollination, and increased disease susceptibility (Purdue University College of Agriculture, 2025, https://ag.purdue.edu/department/entm/extension/field-crops-ipm/corn/corn-rootworms.html; see pg 4, ¶2-3); these damage effects affect numerous plant traits reported in Table 1, including yield, plant height, and ear weight. In plants comprising a locus conversion for rootworm resistance these effects would be reduced or eliminated. The locus conversion(s) used in the plant used to produce Table 1 are not specified and the plant without locus conversion(s) is not described. Thus, as description of X76T002 with one or more locus conversion(s) for insect control and/or herbicide tolerance is not a description of X76T002.
The specification also provides no indication of differences between the plant described in Table 1 from the claimed plant.
The description in the specification is not sufficient to permit comparison of the characteristics of the claimed plant with the prior art.
Further, the plant of claim 5 has a single locus conversion and “otherwise all the physiological and morphological characteristics of hybrid maize X76T002”. However, the specification provides no description of the physiological and morphological characteristics of hybrid maize X76T002.
An incomplete description of the traits of the claimed plant hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the description of the traits of the claimed plant, the public will not be able to fully resolve questions of infringement.
Hence, Applicant has not, in fact, described F1 hybrid maize X76T002 seeds and plants, 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 functional characteristics of the claimed compositions, 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 they have amended the claims (response pg 9).
This is not found persuasive because the amendments do not overcome the incomplete description of the claimed plant.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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.
Claims 4 and 14-20 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth 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.
Parent claim 1 is drawn to a seed of hybrid maize X76T002. Dependent claim 4 is drawn to the seed, further comprising a transgene.
If the seed of claim 1 is a fixed genotype defined by the deposits of parents PGGG27 and PH4D62, the seed further comprising a transgene has different morphological and physiological characteristics and genetics than does X76T002. Thus, the claim fails to include all the limitations of the claim upon which it depends.
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.
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.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo (Joe) Zhou, can be reached at (571) 272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anne Kubelik/Primary Examiner, Art Unit 1662