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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/23/2026 has been entered.
Claim Status
Claims 1, 4-7 and 9-28 are pending.
Claims 2 and 8 are newly canceled.
Claims 1 and 7 are newly amended.
Claims 9-21, 26 and 28 are withdrawn as drawn to an unelected invention.
Claims 1, 4-7, 22-25 and 27 are examined on the merits.
Specification
The disclosure is objected to because of the following informalities: in paragraph 0008 on page 4 of the instant specification there is a typographical error, “antoher” should be changed to “another” and any other similar typographical errors should be corrected.
Appropriate correction is required.
Response to Applicant Arguments – Indefiniteness
With respect to the indefiniteness rejections of record against claims 1 and 4-7, 22-25 and 27 applicant’s arguments and amendments dated 02/23/2026 have been fully considered but are not found to be persuasive. Applicant’s arguments are summarized and addressed below. With respect to claims 2 and 8, applicant’s cancellation of the claims renders the rejections of record against those claims moot and they are withdrawn.
Applicant’s arguments are summarized as follows:
Claims 1 and 7 are amended to further clarify each claim by incorporating the limitations of previous claim 2 into claim 1 and the limitations of previous claim 8 into claim 7, claims 2-6, 22-25, and 27 depend directly or indirectly from claims 1 and 7 and, as such, are rejected under the same basis.
These arguments are not found to be persuasive because while claims 1 and 7 have been amended to incorporate elements from claims 2 and 8 respectively, the addition of these elements is insufficient to limit the scope of the claims to definite subject matter. Evidence of this is that previous claims 2 and 8 were included in the indefiniteness rejections of record.
Specifically, applicant has added the following limitations to the claims:
-The recombinant chromosomal segment comprises allele 2.2 which is characterized by the presence of marker locus M3 (SEQ ID NO: 11)
-The recombinant chromosomal segment also comprises either allele 2.1 characterized by the presence of marker locus M2 (SEQ ID NO: 6), or Dm3, characterized by the presence of any one of marker loci M5-M7 (SEQ ID NOs: 21, 26 and 31, respectively)
-The plant is homozygous for the chromosomal segment
-A representative sample of seed comprising said recombinant chromosomal segment has been deposited under NCMA Accession Nos. 202110051 or NCMA Accession No. 202110049.
These amendments are insufficient to limit the scope of the claim to definite subject matter because the metes and bounds of the structure of the claimed recombinant chromosomal segment remains unclear. Specifically, while these markers are described as being found on the same recombinant chromosomal segment as alleles 2.2 and 2.1 the relationship between these markers and the alleles is unclear. Specifically, it is not clear if any sequence which has the marker has the allele, where the marker is position within the allele, if any sequence which has both of required markers is the claimed recombinant chromosomal segment and if not what other structures are required for a sequence to be the claimed recombinant chromosomal segment.
Further, while the claim recites the deposit information for two deposits of seed which comprise representative samples of the recombinant chromosomal segment it is not clear if the claimed recombinant segments are only those found in the deposited seed, if the segments in the deposited seed are simply non-limiting examples of recombinant segments or if there is some other relationship between the deposit and the claimed segments. Even if the claimed segments are limited to those found in the deposited seeds, the bounds of the segment are not clear and as noted above, if the segments require any other features beyond the two markers those features are unclear and as such even if the segments were limited to those found in the deposited seed, the structure of the claimed segments is unclear.
As such applicant’s arguments that the amended claims are definite are not found to be persuasive and the rejections of record are maintained.
Claim Rejections - 35 USC § 112 (Indefiniteness)
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 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
This rejection is maintained for the reasons of record, because the amendments and remarks by Applicants in response to Office Action mailed on February 23, 2026, have been fully considered but not deemed persuasive. See above for the response to Applicant's remarks.
Claims 1 and 4-7, 22-25 and 27 remain 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 which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 1 and 7, the recitation of “allele 2.2” and “allele. 2.1” render the claim indefinite. This is because it is not clear what scope is imparted onto the claims by these terms and as such the recombinant chromosomal segment is not clear. The specification on page 28 in paragraph 0090 describes markers that are associated with these alleles. Further, Figure 3 in the drawings dated November 21, 2022 provide a rough map of the alleles and the markers. However, this description is not sufficient to allow the ordinary artisan to understand the scope conferred by the reference of these two names. This is for at least three reasons.
First the reference to chromosome 2 is not clear, without this, even aligning the marker sequences to the reference would not allow for the sequence which makes up each allele to be determined.
Second, because as demonstrated by figure 3, the markers are not found at the far boundaries of each allele even aligning the markers to the correct reference sequence would not allow for the entire sequence of each allele to be identified. This is important because it is not clear what features are found in the regions outside of the markers and further if they are important for the function of pathogen resistance.
Finally, it is not clear if allele 2.1 and allele 2.2 refer only to the structures described in figure 3 or if they are drawn to a genus of which the allele 2.1 and allele 2.2 of figure 3 and paragraph 0090 and 0091 of the specification are single species.
Even applicant’s amendments to claims 1 and 7 which further limit the claims to alleles which are characterized by the presence of specific marker sequences and a reference to deposits of representative samples of seed comprising said recombinant chromosomal segments are insufficient to limit the scope to definite subject matter. This is because the metes and bounds of the structure of the claimed recombinant chromosomal segment remains unclear. Specifically, while these markers are described as being found on the same recombinant chromosomal segment as alleles 2.2 and 2.1 the relationship between these markers and the alleles is unclear. Specifically, it is not clear if any sequence which has the marker has the allele, where the marker is position within the allele, if any sequence which has both of required markers is the claimed recombinant chromosomal segment and if not what other structures are required for a sequence to be the claimed recombinant chromosomal segment.
Further, while the claim recites the deposit information for two deposits of seed which comprise representative samples of the recombinant chromosomal segment it is not clear if the claimed recombinant segments are only those found in the deposited seed, if the segments in the deposited seed are simply non-limiting examples of recombinant segments or if there is some other relationship between the deposit and the claimed segments. Even if the claimed segments are limited to those found in the deposited seeds, the bounds of the segment are not clear and as noted above, if the segments require any other features beyond the two markers those features are unclear and as such even if the segments were limited to those found in the deposited seed, the structure of the claimed segments is unclear.
Dm3 is not included in this rejection because this allele is known in the art, see US 10 , 273 , 499 B2. However, allele 2.1 and allele 2.2 are generic names which do not appear to have a specific meaning in the art. Therefore claims 1 and 7 are rejected as indefinite and claims 2, 4-6, 8, 22-25 and 27 are rejected as depending on an indefinite claim and failing to limit the claim scope to definite subject matter.
Response to Applicant Arguments – Enablement
With respect to the enablement rejections of record against claims 1 and 4-7, 22-25 and 27 applicant’s arguments and amendments dated 02/23/2026 have been fully considered but are not found to be persuasive. Applicant’s arguments are summarized and addressed below. With respect to claims 2 and 8, applicant’s cancellation of the claims renders the rejections of record against those claims moot and they are withdrawn.
Applicant’s arguments are summarized as follows:
Claims 1 and 7 are amended to further clarify each claim by incorporating the limitations of previous claim 2 into claim 1 and the limitations of previous claim 8 into claim 7, claims 2-6, 22-25, and 27 depend directly or indirectly from claims 1 and 7 and, as such, are rejected under the same basis.
These arguments are not found to be persuasive because while claims 1 and 7 have been amended to incorporate elements from claims 2 and 8 respectively, the addition of these elements is insufficient to limit the scope of the claims to enabled subject matter. Evidence of this is that previous claims 2 and 8 were included in the enablement rejections of record.
Specifically, applicant has added the following limitations to the claims:
-The recombinant chromosomal segment comprises allele 2.2 which is characterized by the presence of marker locus M3 (SEQ ID NO: 11)
-The recombinant chromosomal segment also comprises either allele 2.1 characterized by the presence of marker locus M2 (SEQ ID NO: 6), or Dm3, characterized by the presence of any one of marker loci M5-M7 (SEQ ID NOs: 21, 26 and 31, respectively)
-The plant is homozygous for the chromosomal segment
-A representative sample of seed comprising said recombinant chromosomal segment has been deposited under NCMA Accession Nos. 202110051 or NCMA Accession No. 202110049.
These amendments are insufficient to limit the scope of the claim to enabled subject matter because the metes and bounds of the structure of the claimed recombinant chromosomal segment remains unclear and as such the claim remains broad and its use would require undue experimentation. Specifically, while these markers are described as being found on the same recombinant chromosomal segment as alleles 2.2 and 2.1 the relationship between these markers and the alleles is unclear. Specifically, it is not clear if any sequence which has the marker has the allele, where the marker is position within the allele, if any sequence which has both of required markers is the claimed recombinant chromosomal segment and if not what other structures are required for a sequence to be the claimed recombinant chromosomal segment.
Further, while the claim recites the deposit information for two deposits of seed which comprise representative samples of the recombinant chromosomal segment it is not clear if the claimed recombinant segments are only those found in the deposited seed, if the segments in the deposited seed are simply non-limiting examples of recombinant segments or if there is some other relationship between the deposit and the claimed segments. Even if the claimed segments are limited to those found in the deposited seeds, the bounds of the segment are not clear and as noted above, if the segments require any other features beyond the two markers those features are unclear and as such even if the segments were limited to those found in the deposited seed, the structure of the claimed segments is unclear. Therefore, while the inclusion of these new limitations in the claim slightly narrows the overall scope of the claims it does not appear to limit the scope of the claim to subject matter which has sufficient enabled guidance such that a skilled artisan could make and use the invention without undue experimentation. As such the rejections of record against these claims are maintained.
Claim Rejections - 35 USC § 112 - Enablement
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.
This rejection is maintained for the reasons of record, because the amendments and remarks by Applicants in response to Office Action mailed on February 23, 2026, have been fully considered but not deemed persuasive. See above for the response to Applicant's remarks.
Claims 1, 4-7, 22-25 and 27 remain 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.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
The claimed products and methods require a broad genus of an elite lettuce plant having a recombinant chromosomal segment comprising a first allele, allele 2.2, characterized by the presence of marker locus M3 and a second allele, allele 2.1, characterized by the presence of marker locus M2 or Dm3, characterized by the presence of a marker from the group of M5-M7, where the two alleles are in cis configuration on chromosome 2 and confer resistance to Bremia lactucae polypeptide and where the plant is homozygous for the recombinant chromosomal segment and wherein representative sample of seed comprising said recombinant chromosomal segment has been deposited under NCMA Accession No. 202110051 or NCMA Accession No. 202110049.
The genus of these plants is broad in scope because as discussed in the indefiniteness rejection above, the scope of allele 2.1 and allele 2.2 are not clear. Further breadth is added by the nearly infinite arrangements of the two alleles on chromosome 2. The activity and expression of these alleles would be dramatically affected by the chromosomal context in which they are located and further modified by the regulatory elements to which they are linked or not linked.
The independent claim has been amended to limit the scope to chromosomal segments comprising a at least two marker loci selected from a group which include sequences as short as 21 nucleotides (SEQ ID NO: 17; Marker Locus M4). Even limiting the recombinant chromosomal segments to those that comprise that marker loci retains breadth as this sequence could be found in/added to any number of sequences and further the presence of this marker does not imply any structure or sequence of the two alleles or their arrangement which would be critical in conferring the pathogen resistance required by the claim (Emphasis added by examiner).
To summarize, the independent claim appears to be drawn to nearly any sequence (allele 2.1 and/or allele 2.2) in any arrangement on chromosome 2 as long as the sequence comprises at least the marker locus of SEQ ID NO: 11 and any of the other marker sequences in the claim as long as the two sequences are on the same homologous chromosome, in any context, linked to any regulatory elements.
This leads to an incredible number of combinations that represent the breadth of the claimed genus.
Other claims limit the scope of the independent claim to plant parts, recombinant DNA segments having the features described in claim 1, methods of selecting lettuce plants exhibiting pathogen resistance, and tissue cultures comprising cells from the plant of claim 1.
In contrast, the Specification has described general and non-limiting arrangement of resistance alleles within a chromosome and potential markers within those alleles. Further, applicant has provided deposits of two elite lettuce varieties having the requisite claimed structure and which exhibit the required pathogen resistance (Specification, Page 28, Paragraph 0089 – Page 29, Paragraph 0091; Specification, Page 26, Paragraph 0083). However, even though the deposit information has been added to the claim, given the specific language used it does not appear that the claims are limited to plants from the deposited lines and therefore the description of those lines does not provide adequate guidance to produce the broadly claimed products or use the broadly claimed methods.
However, the Specification has not described any of the above listed broad genera of alleles 2.1 or 2.2 or the even more broad genus of recombinant chromosomal segments.
The specification fails to sufficiently describe the necessary structural features that must be retained by the members of the above listed broad genera as to establish a structure-function relationship with respect to the specific function of enhanced resistance to B. lactucae.
Firstly, it is unclear which sequences are 2.1 or 2.2 alleles and what structures must be retained by members of these species in order to have the functional activity of increasing resistance to pathogen, beyond the presence of the marker loci as described in the claims.
Moreover, it should be noted that the specific amount of expression and control of expression of these alleles in order to confer increased resistance to pathogens is not clear and does not appear to be predictable given applicants disclosure.
Furthermore, the markers described in the claims do not appear to be known in the art. Therefore, developing or identifying these markers in any sequence that could be introduced into a recombinant chromosomal segment would require extensive trial and error experimentation.
Therefore, the state of the art speaks a general lack of functional characterization of the vast number of members of the genus of potential allele 2.1 and allele 2.2 and lack of knowledge about potential markers associated with these alleles. Thus, the state of the art at the time of the instant invention was that although the skilled artisan would recognize the Dm3 and other pathogen resistance alleles, one would not be able to readily predict if a sequence was an allele 2.1 or 2.2.
Therefore, Applicants have not adequately described the structural features that are required to be retained by members of the claimed genus as to establish a structure-function relationship, or the structural features required to distinguish members of the claimed genus from other chemical structures.
The analysis will now turn to the second element of the court’s decision in Eli Lilly; namely, the description of a representative number of species. As discussed above, the broad genera of recombinant chromosomal fragments, encompass a large number of polynucleotides.
Given the virtually infinite structural variable associated with these embodiments, the claims read on an extremely broad and highly diverse structures. Thus, in view of the analysis presented above, a skilled artisan would appreciate that the claims are directed to extremely broad and highly diverge genera of recombinant chromosomal segments.
In contrast, Applicant has only appeared to describe and reduce to practice two specific lettuce lines having the claimed arrangement of alleles and having increased pathogen resistance to B. lactucae.
Given the large size and structural diversity associated with the claimed genus, Applicant’s disclosure is not representative of the claimed genus as a whole. This point is particularly relevant because, as discussed above, the prior art speaks to the disconnection between the structure of the broadly claimed variants and the recited specific function.
Thus, based on the analysis above, Applicant has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly. As a result, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
Close Prior Art
The claims appear to be free of the prior art. The closest prior art appears to be US 10,273,499 B2, referred hereafter as ‘499, which is drawn to lettuce plants which are resistant to Bremia lactucae and which comprise an introgression at chromosome 2 that includes DM3 (‘499, Abstract; ‘499, Page 3, Paragraph 0031; ‘499, Page 5, Paragraph 0052). However, ‘499 is silent on any allele 2.1 or allele 2.2 alleles.
Conclusion
Claims 1, 4-7, 22-25 and 27 remain rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached on 7:30 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663