Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 26-48 are pending.
Claims 39-48 are withdrawn.
Claims 26-38 are examined.
Election/Restrictions
Applicant’s election of Group I, claims 26-38, in the reply filed on 10/27/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 28-31 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 lettuce plant with resistance to downy mildew, wherein the plant comprises a MACPF1 gene encoding a protein with at least 90% identity to SEQ ID NO: 4 with 16 specific amino acids at specified positions wherein the lettuce plant is not Lactuca serriola. Claim 29 specifies that downy mildew is caused by Bremia lactucae, claim 30 specifies the downy mildew is caused by one or more Bremia lactucae races Bl1 to Bl33. Claim 31 specifies that the protein comprises aspartic acid at position 590.
Applicant describes transformation of lettuce (L. sativa) with each of three constructs (page 11 lines 25-28). Applicant describes one construct resulting in increased resistance to downy mildew, the construct which encoded MACPF1R i.e. SEQ ID NO: 4 (page 13 lines 10-15).
Applicant does not describe a lettuce plant encoding only 90% identity to SEQ ID NO: 4 with the exception of the 16 specified amino acids or 17 specified amino acids (claim 31). Applicant has not described a representative number of species across the claimed genus. Applicant has not described the protein which was observed to confer downy mildew resistance in any species other than Lactuca sativa. Applicant appears to have only tested for resistance to Bl 24 and Bl 32 (page 13, lines 8-9).
Therefore, one of ordinary skill in the art would not have recognized the applicant to be in possession of the claimed genus.
Scope of Enablement- How to use
Claims 26-27 and 32-38 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 using a lettuce plant for improved downy mildew resistance comprising a gene encoding SEQ ID NO: 4, does not provide enablement for a lettuce plant comprising a gene encoding SEQ ID NO: 4 that is not able to confer the associated phenotype. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with the claim.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the 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 claim.
The claims are broadly drawn to the products comprising a gene encoding a polypeptide of SEQ ID NO: 4 regardless of whether the gene is able to confer any useful phenotype to a lettuce plant comprising the polypeptide encoded by the gene or has any function whatsoever.
Applicant teaches that expression of the polypeptide of SEQ ID NO: 4 leads to increased downy mildew resistance in lettuce plants (page 14, lines 10-13).
Applicants do not teach how one of skill in the art could use a lettuce plant comprising a nucleotide sequence encoding SEQ ID NO: 4 wherein the polypeptide is non-functional.
The state-of-the-art is such that one of skill in the art cannot predict how one of skill in the art could use any of the products that comprise a nucleotide sequence encoding a polypeptide of SEQ ID NO: 4 wherein the polypeptide encoded by the DNA is non-functional.
Given the lack of guidance in the instant specification, undue trial and error experimentation would have been required for one of ordinary skill in the art to use the claimed invention throughout the broad scope of the claim.
Therefore, given the breadth of the claim; the lack of guidance and working examples; the unpredictability in the art; and the state-of-the-art as discussed above, undue experimentation would have been required to practice the claimed invention, and therefore the invention is not enabled throughout the broad scope of the claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 26-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. US11920144 (‘144). Although the claims at issue are not identical, they are not patentably distinct from each other.
Applicant instantly claims a lettuce plant with resistance to downy mildew, wherein the plant comprises a MACPF1 gene encoding a protein with at least 90% identity to SEQ ID NO: 4 with 16 specific amino acids at specified positions wherein the lettuce plant is not Lactuca serriola (claims 26 and 34). Applicant claims the lettuce is one from a Markush group of lettuce species (claims 27 and 35). Claim 28 specifies that the plant is resistant to downy mildew, claim 29 specifies that downy mildew is caused by Bremia lactucae, claim 30 specifies the downy mildew is caused by one or more Bremia lactucae races Bl1 to Bl33. Applicant specifies that the protein comprises aspartic acid at position 590 (claims 31 ad 36). Claims 32 and 37 require the encoded protein to have at least 95% identity to SEQ ID NO: 4; claims 33 and 38 requires at least 98% identity to SEQ ID NO: 4.
Patent ‘144 discloses a lettuce plant comprising a nucleotide sequence encoding SEQ ID NO: 4, including the same Markush group of lettuce species and downy mildew races and methods of obtaining the lettuce plant. Patent ‘144 is a species of the instantly claimed genus and therefore anticipates the instantly claimed invention.
Closest Prior Art
The instantly claimed invention is free of the prior art. The closest prior art is sequence XP_023731234 (NCBI Reference Sequence: XP_023731234.1), from Lactuca sativa, which shares 97.16% identity to SEQ ID NO: 4 but does not comprise any of the specified amino acid residues other than serine at position 450. All of the specified residues are required by the instantly claimed invention, therefore XP_023731234 does not anticipate the instantly claimed invention and no other teachings or suggestions in the prior art in combination with XP_023731234 make obvious the instantly claimed invention.
Conclusion
Claims 26-38 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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/DAVID R BYRNES/Examiner, Art Unit 1662