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 .
Status of the Claims
Claims 1-10 and 13-15 are pending.
Claims 2-4, 6-7, 9-10, and 13-15 are withdrawn from consideration as being drawn to a non-elected invention.
Elected claims 1, 5, and 8 are examined herein.
Claims 1, 5, and 8 are rejected.
Priority
Application No. 18/696,399 filed on 03/28/2024 is a 371 of PCT/EP2021/076790 filed on 09/29/2021.
Election/Restrictions
Applicant’s election without traverse of Group I, encompassing claims 1, 5, and 8 drawn to a lettuce plant resistant to Bremia, the lettuce plant comprising a first and a second Bremia-resistance providing genomic fragment from Lactuca serriola and Applicant’s election of species SEQ ID NOs: 3 and 13 in the reply filed on 06/05/2026 is acknowledged.
Claim Interpretation
The term “lettuce” in the claims and disclosure is interpreted to refer to plants of the species Lactuca sativa. See specification, p. 1, lines 10-11.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See hyperlink in specification at least on p. 12, lines 2 and 25, p. 14, last line, p. 15, line 17, p. 16, line 21, p. 19, line 2.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claim recites “An edible part, pollen, egg cell, callus, suspension culture, somatic embryo, clone, embryo or plant part of a lettuce plant resistant to Bremia according to claim 1.”
The claim(s) encompass at least pollen, egg cell, embryo, and seeds that are identical to those that would be found in nature because, for example, if the plant is not homozygous for the genomic fragment or sequence(s), a subset of the pollen, egg cells, embryos, and seeds produced by the lettuce plant would be expected to be not comprise the claimed sequence(s) from Lactuca serriola and therefore identical to those found in a naturally occurring lettuce plant as a result of segregation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are recited in the claims that would make the pollen, egg cell, embryo, or seed structurally different from a naturally occurring pollen, egg cell, embryo, or seed of lettuce plant.
Claim Rejections - 35 USC § 112
Written Description
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 1, 5, and 8 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.
Claims 1, 5, and 8 are broadly drawn to a lettuce plant resistant to Bremia, the lettuce plant comprising a first and a second Bremia-resistance providing genomic fragment from Lactuca serriola, wherein the first Bremia-resistance providing genomic fragment is located on chromosome 4 of the lettuce plant and comprises a nucleic acid sequence selected from the group consisting of SEQ ID No. 1, SEQ ID No, 3, SEQ ID No 5, SEQ ID No, 7 and SEQ ID No, 9; and the second Bremia-resistance providing genomic fragment is located on chromosome 8 of the lettuce plant, and comprises a nucleic acid sequence selected from the group consisting of SEQ ID No, 11, SEQ ID No 13, SEQ ID No 15, SEQ ID No, 17 and SEQ ID No. 19.
Applicant describes in working examples lettuce plants comprising “C4+C8” were resistance to Bremia (p. 11-12, Example 3, and Table 2) indicating that the lettuce plant comprised all of SEQ ID NOs: 1, 3, 5, 7, and 9 on chromosome 4 and all of SEQ ID NOs: 11, 13, 15, 17, and 19 on chromosome 8 of a lettuce plant. Applicant has described the resistance derived from the L. serriola is a polygenic resistance which localizes on chromosome 4 between 282.9 and 291.3.8 Mbp and chromosome 8
between 47.5 and 56.8 Mbp in L. sativa, and the SNPs/markers are based on the sequence of a lettuce line containing the resistance (thus this lettuce line had all of the SNP markers) (p. 12, liens 11-20). Further, Applicant suggests transforming Lactuca sativa plants with the chromosome 4 and 8 genomic fragments from L. serriola (i.e. all SNPs) may confer Bremia resistance (p. 19, Example 5).
Applicant has not described in a working example a lettuce plant with only a single nucleic acid sequence selected from any of SEQ ID NOs: 1, 3, 5, 7, and 9 on chromosome 4 and also only a single nucleic acid sequence selected from any of SEQ ID NOs: 11, 13, 15, 17, and 19 on chromosome 8 that is resistant to Bremia. For example, Applicant has not described only a single sequence on each of chromosome 4 and 8 as recited in the claims in any combination that has been either introduced via crossing or transformed into a lettuce plant and is resistant to Bremia, as is encompassed by the breadth of the claims.
The prior art fails to remedy this deficiency because none of the SNPs represented in the sequences of SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, and 19 appear in the prior art and are attributed to conferring Bremia resistance.
Thus, there is a dearth of description of a single claimed sequence at each of chromosome 4 and 8 that would be expected to confer the function of Bremia resistance. The instant specification fails to describe an adequate written description of the genus of any single SNP at each of chromosome 4 and 8 (the SNPs being represented in the SEQ ID NOs) in claim 1, or any combination of a single SNP at each of chromosome 4 and 8, that is able to effectively confer Bremia resistance to a lettuce plant. The limited example of lettuce comprising all of the sequences/ SNPs does not describe the claimed genus by virtue of example. Therefore, one of ordinary skill in the art would not have recognized the Applicant to be in possession of the claimed invention at the time the application was filed.
Closest Prior Art
Claims 1, 5, and 8 appear free of the prior art.
Regarding claims 1, 5, and 8, the closest prior art is Scheurwater (WO-2014131857-A1). Scheurwater teaches Lactuca sativa plant resistant to Bremia lactucae, comprising a Bremia resistance locus which is linked to a genetic determinant, said genetic determinant is obtainable from the genome of a wild Lactuca plant, preferably from the genome of Lactuca serriola, characterized in that said resistance locus is a broad spectrum locus, providing resistance to Bremia lactucae races Bl : 1 to Bl : 28 (Claim 1 of Scheurwater). However, Scheurwater does not disclose, teach, or otherwise render obvious the limitations recited in instant claim 1 that is a lettuce plant comprising a first and a second Bremia-resistance providing genomic fragment from Lactuca serriola, wherein the first Bremia-resistance providing genomic fragment is located on chromosome 4 of the lettuce plant and comprises a nucleic acid sequence selected from the group consisting of SEQ ID No. 1, SEQ ID No, 3, SEQ ID No 5, SEQ ID No, 7 and SEQ ID No, 9; and the second Bremia-resistance providing genomic fragment is located on chromosome 8 of the lettuce plant, and comprises a nucleic acid sequence selected from the group consisting of SEQ ID No, 11, SEQ ID No 13, SEQ ID No 15, SEQ ID No, 17 and SEQ ID No. 19.
This is because the sequences represented by SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, and 19 comprise SNPs obtained from a cross with what appears to be an individual L. serriola plant found to be resistant to all races of Bremia (Bl:16EU- Bl:37EU) according to the specification (p. 11, lines 11-14), and none of the sequences and SNPs within the sequences expressly appear in the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA N STOCKDALE whose telephone number is (703)756-5395. The examiner can normally be reached M-F 8:30-5:00 CT.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662
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