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 .
Claims 1-21 are pending. Claims 14-19 remain withdrawn by the Examiner as being drawn to nonelected subject matter.
Claims 1-13 and 20-21 are examined herein on the merits.
Claim Objections
Claims 2-15 are objected to because of the following informalities: The claims appear to have been amended deleted the claim dependency without annotation that the claims are amended. Appropriate correction is required.
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.
Claims 2-13 and 20-21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims all recite “Thereof of claim “ wherein the claim number for dependency is not listed. Accordingly, the metes and bounds of the claims are not defined. It is believed that Applicant intended the claims to depend from claim 1, but this must be corrected.
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.
Claims 1-13 remain and claims 20-21 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
The claims are all drawn to a potato, potato part or potato seed comprising an S-RNase allele encoding a transcript 95% or more identical to SEQ ID NO:1 and lacking an S-RNase allele encoding a transcript 95% or more identical to SEQ ID NO:2, wherein the S-RNase allele encoding a transcript 95% or mor identical to SEQ ID NO:1 is from potato variety PG6359.
In contrast, the specification only teaches potato variety PG6359 which according to the specification comprises both of the recited alleles and therefore does not meet the limitations of the claims (see Example 2 where transcript is measured for both alleles and is present). The specification does not teach any other potato let alone any other potato meeting the limitations of the instant claims. Additionally the specification does not describe how one would obtain such a potato, what starting materials would be required, and indeed the prior art is silent about what potato starting material would be lacking the ssub12 allele as described in the instant specification as SEQ ID NO:2.
This is problematic because the claims further require the potato to be a self-compatible diploid potato. In an article entitled “Overcoming Self-Incompatibility in Diploid Potato Using CRISPR-Cas9”, Enciso-Rodriguez et al (2019 Frontiers in Plant Science 10:1-12) state “A significant barrier to this approach is the occurrence of gametophytic self-incompatibility (SI) in a majority of the diploid potato germplasm, thereby preventing the ability to generate diploid homozygous lines.
In diploid potato, the gametophytic SI system is controlled by a single multiallelic locus called the S-locus (Porcher and Lande, 2005). This locus is composed of tightly linked genes, S-RNase (S-locus RNase) and SLFs (S-locus F-box) genes known also as S-haplotype-specific F-box brothers (SFBB), expressed in the style and pollen, respectively”. Accordingly, with tightly linked genes, unlinking the incompatible genes would be difficult.
The specification does not provide any description of how to arrive at the claimed potato, nor does it describe a potato with the claimed characteristics.
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive.
Applicants urge that the specification expressly discloses diploid potato plants containing homozygous alleles and they are self-compatible, and that the specification describes that PG6359 contains two full-length sequences and then describes selfing to obtain segregating progeny and performing genotyping, and that the inventors obtained potatoes that contain the s11 allele but lack the s12 allele (see page 1 of response).
This is not persuasive because Applicants have stated that they have obtained said potatoes, but they have not described said potatoes. There are no deposits of said potatoes, no pictures or evidence of any kind such that one of skill in the art would be able to determine whether or not the inventors are in possession of the claimed subject matter. Furthermore, the material used to cross with PG6359 is not presented such that one of skill in the art could even duplicate the Examples. For example, the specification does not even require a specific potato, but states “performing artificial self-pollination for more than 200 diploid potatoes at flowering stage, selecting a self-compatible potato variety material and referring to it as PG6359”. This would encompass literally just calling a potato PG6359 with any genetic background whatsoever with the only limitation being at the S allele. This is insufficient for describing the subject matter in a way that would allow one of skill in the art to determine possession of the claimed subject matter.
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.
Claims 1-13 remain and claims 20-21 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claims contain 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 claims are all drawn to a potato, potato part or potato seed comprising an S-RNase allele encoding a transcript 95% or more identical to SEQ ID NO:1 and lacking an S-RNase allele encoding a transcript 95% or more identical to SEQ ID NO:2, wherein the S-RNase allele encoding a transcript 95% or mor identical to SEQ ID NO:1 is from potato variety PG6359.
In contrast, the specification only gives guidance to potato variety PG6359 which according to the specification comprises both of the recited alleles and therefore does not meet the limitations of the claims (see Example 2 where transcript is measured for both alleles and is present). The specification does not teach any other potato let alone any other potato meeting the limitations of the instant claims. Additionally the specification does not give guidance how one would obtain such a potato, what starting materials would be required, and indeed the prior art is silent about what potato starting material would be lacking the ssub12 allele as described in the instant specification as SEQ ID NO:2.
This is problematic because the claims further require the potato to be a self-compatible diploid potato. In an article entitled “Overcoming Self-Incompatibility in Diploid Potato Using CRISPR-Cas9”, Enciso-Rodriguez et al (2019 Frontiers in Plant Science 10:1-12) state “A significant barrier to this approach is the occurrence of gametophytic self-incompatibility (SI) in a majority of the diploid potato germplasm, thereby preventing the ability to generate diploid homozygous lines.
In diploid potato, the gametophytic SI system is controlled by a single multiallelic locus called the S-locus (Porcher and Lande, 2005). This locus is composed of tightly linked genes, S-RNase (S-locus RNase) and SLFs (S-locus F-box) genes known also as S-haplotype-specific F-box brothers (SFBB), expressed in the style and pollen, respectively”. Accordingly, with tightly linked genes, unlinking the incompatible genes would be difficult.
Given the state of the art, the lack of working examples, the lack of starting material, and the unpredictability in the art as described by Enciso-Rodriguez et al as mentioned above, it would be undue experimentation for one of skill in the art to arrive at the instantly claimed potato without the starting material or guidance of how to break linkage of the two incompatible loci,
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive.
Applicants urge that all diploid plants can be used as starting material and that it is the low expression of the S11 allele and that the PG6359 did not contain the S12 genotype (see pages 2-4 of response).
This is not persuasive because the starting material for the claimed products, potatoes, are not provided by way of deposit, nor in any other way that would be accessible to the public. Although Applicant’s assert that any diploid potato may be used as starting material, it is unclear how such a prior art potato is then altered such that it would meet the limitation of the instant claims. Applicant’s appear to have developed markers from sequences that merely identify what would normally occur from any diploid potato crossing. Applicant should clarify this as the current claims are drawn to products, and as such the products must be enabled in such a way that they can be made and used within the scope of the claims as currently written.
No claims are allowed.
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 BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 EST.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663
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