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 .
Claim Status
Claims 1, 4-7 and 9-28 are pending.
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Claims 9-21, 26 and 28 are withdrawn as drawn to an unelected invention.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 remain rejected.
Response to Applicant Arguments - Specification
In response to Applicant’s arguments and amendments to the specification dated 06/22/2026, the objection to the specification of record is withdrawn.
Response to Applicant Arguments - Indefiniteness
In response to Applicant’s arguments and amendments to the claims dated 06/22/2026, the indefiniteness rejections of record are withdrawn.
Response to Applicant Arguments – Enablement
Applicant’s remarks and amendments to the claims have been fully considered but are not found to be persuasive and the rejections of record are maintained. Given, Applicant’s amendments to the claims, the rejections of record have been modified to more directly address issues related to the amended scope of the “recombinant chromosomal segment”.
Applicant’s arguments are summarized and addressed as follows:
By defining the recombinant chromosomal segment as flanked by marker locus M1 (SEQ ID NO: 1) and marker locus M4 (SEQ ID NO: 16), the claims are now limited to a specific bounded region of chromosome 2.
The removal of the undefined terms “allele 2.2” and “allele 2.1” eliminates the concern regarding a “broad genus” of unknown alleles”.
The specification discloses the deposited elite lettuce varieties having the requisite claimed structure and which exhibit the required pathogen resistance.
The arguments summarized in 1. above have been fully considered but are not found to be persuasive because while the claims have been amended to include the following limitation “wherein said recombinant chromosomal segment is flanked in the genome of said plant by marker locus M1 (SEQ ID NO: 1) and marker locus M4 (SEQ ID NO: 16), this does not limit the scope of the claims to subject matter which as been adequately described.
This is due to the breadth of the claimed recombinant chromosomal segment. In the claims Applicant has provided the following limitations on the structures of the recombinant chromosomal segment.
The segment must comprise a first allele that confers resistance to Bremia lactucae and a second allele that confers resistance to Bremia lactucae where the two alleles are on the same chromosome (in cis configuration).
The segment is flanked in the genome by marker locus M1 (SEQ ID NO: 1) and marker locus M4 (SEQ ID NO: 16).
The first allele comprises marker locus M3 (SEQ ID NO: 11).
The second allele comprises marker locus M2 (SEQ ID NO: 6) or Dm3.
To summarize, the broadest reasonable interpretation of the claimed recombinant segment includes those sequences having one or more genetic loci in a configuration in which they are not found in nature, having the following structures a first allele which comprises the 111 base pair sequence of SEQ ID NO: 11 a second allele which either comprises the 87 base pair sequence of SEQ ID NO:6. Where the segment is flanked in the plant genome by the sequences of SEQ ID NO: 1 and SEQ ID NO: 16.
Given the language of the claim the new limitation limits the claimed segments to those found between two sequences, but given that these sequences are not linked to a specific fixed reference sequence the “recombinant segment” between the two flanking sequences can be variable and the broadest reasonable interpretation of the claim is that any sequence found anywhere on chromosome 2 which is flanked by the sequences of SEQ ID NOs: 1 and 16 and has the other required features is the recombinant chromosomal segment.
Further, given the claim language, specifically the lack of a link between the marker loci of SEQ ID NO: 11 and SEQ ID NO: 6 and any specific alleles the recombinant segment can be any sequence which has both SEQ ID NO: 11 and SEQ ID NO: 6, is flanked by the sequences of SEQ ID NOs: 1 and 16, is found on a chromosome 2 and confers resistance to Bremia lactucae, even if the chromosomal segment otherwise has no similarity whatsoever to the sequences found in the deposited seed.
Therefore, Applicant’s arguments summarized in 1. Above are not found to be persuasive because through biotechnological means any sequence could be inserted between the two claimed flanking sequences and this segment could then be inserted anywhere on chromosome two.
Further, as noted in the analysis above, given Applicant’s other amendments to the claims, the recombinant segment reads on an extremely large and diverse genus of sequences which are required to have the function of conferring resistance to Bremia lactucae and Applicant has not provided sufficient guidance for the ordinary artisan to make and use the claimed invention.
With respect to Applicant’s arguments summarized in 2. above, these arguments are fully considered but not found to be persuasive because while removing the terms removes issues related to indefiniteness it does not add any specifics on the structures of the alleles found in the recombinant segment, see response to Applicant’s remarks summarized in 1. above.
With respect to Applicant’s arguments summarized in 3. above, these arguments are fully considered but are not found to be persuasive. While the claims include reference to the deposit and the specification discloses the deposited elite lettuce varieties having the requisite claimed structure and which exhibit the required pathogen resistance, the claims are not limited to the deposited seeds or sequences. Instead, the deposited seeds are a “representative sample of seed comprising said recombinant chromosomal segment”. Given the breadth of the “recombinant chromosomal segment” these two reductions to practice of the claimed invention are insufficient guidance for the ordinary artisan to make and use the full scope of the claimed invention without undue experimentation.
Therefore, Applicant’s arguments are not found to be persuasive and the rejections of record while modified to address the new limitations 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.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 03/23/2026 as applied to claims 1, 4-7, 22-25 and 27. Applicant’s arguments filed on 06/22/2026 have been fully considered but they are not persuasive, see above.
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, characterized by the presence of marker locus M3 (SEQ ID NO: 11) and a second allele, which is either an allele characterized by the presence of marker locus M2 (SEQ ID NO: 6) or a Dm3 allele, , where the two alleles are in cis configuration on chromosome 2, flanked by the sequences of marker locus M1 (SEQ ID NO: 1) and marker locus M4 (SEQ ID NO: 16) 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 structures required by the claimed recombinant chromosomal segment are broad.
In the claims Applicant has provided the following limitations on the structures of the recombinant chromosomal segment.
The segment must comprise a first allele that confers resistance to Bremia lactucae and a second allele that confers resistance to Bremia lactucae where the two alleles are on the same chromosome (in cis configuration).
The segment is flanked in the genome by marker locus M1 (SEQ ID NO: 1) and marker locus M4 (SEQ ID NO: 16).
The first allele comprises marker locus M3 (SEQ ID NO: 11).
The second allele comprises marker locus M2 (SEQ ID NO: 6) or Dm3.
To summarize, the broadest reasonable interpretation of the claimed recombinant segment includes those sequences having one or more genetic loci in a configuration in which they are not found in nature, having the following structures a first allele which comprises the 111 base pair sequence of SEQ ID NO: 11 a second allele which either comprises the 87 base pair sequence of SEQ ID NO:6. Where the segment is flanked in the plant genome by the sequences of SEQ ID NO: 1 and SEQ ID NO: 16.
Given the language of the claim the new limitation limits the claimed segments to those found between two sequences, but given that these sequences are not linked to a specific fixed reference sequence the “recombinant segment” between the two flanking sequences can be variable and the broadest reasonable interpretation of the claim is that any sequence found anywhere on chromosome 2 which is flanked by the sequences of SEQ ID NOs: 1 and 16 and has the other required features is the recombinant chromosomal segment.
Further, given the claim language, specifically the lack of a link between the marker loci of SEQ ID NO: 11 and SEQ ID NO: 6 and any specific alleles the recombinant segment can be any sequence which has both SEQ ID NO: 11 and SEQ ID NO: 6, is flanked by the sequences of SEQ ID NOs: 1 and 16, is found on a chromosome 2 and confers resistance to Bremia lactucae, even if the chromosomal segment otherwise has no similarity whatsoever to the sequences found in the deposited seed.
The independent claim limits the scope to chromosomal segments comprising 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).
Similarly, as noted above, limiting the segments to those flanked by the sequences of SEQ ID NOs: 1 and 16 does not imply any structure between the two flanking markers.
To summarize, the independent claim appears to be drawn to nearly any sequence (a first allele comprising and a second allele) 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 and flanked by the sequence of SEQ ID NOs: 16 and 1.
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 any allele comprising SEQ ID NO:11 and any allele comprising SEQ ID NO: 6 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 what structures must be retained by the claimed alleles 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 Applicant’s 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 alleles 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 one of the two claimed alleles or if it would have the requisite function.
Therefore, Applicants have not provided sufficient guidance for the ordinary artisan to determine if an allele was one of the claimed alleles and correspondingly the ordinary artisan would be required to use undue experimentation to make and use the full scope of the claimed invention.
Given the virtually infinite structural variable associated with these embodiments and the lack of enabled guidance; in order to make and use the full scope of the claimed invention the ordinary artisan would be required to use trial and error experimentation which would be extensive.
Specifically, the ordinary artisan would be required to assay any combination of two alleles which comprised the requisite marker loci. This would include introducing the marker sequences into any allele. Then these two alleles would have to be arranged in different organizations, flanked by the two flanking sequences, transformed into chromosome two in a variety of places and then plants comprising this chromosome would have to be evaluated for resistance to Bremia lactucae.
This is a large amount of work and given the lack of guidance on the structures and features of the two alleles which must be maintained it is clear that this amounts to undue experimentation.
Thus, in view the lack of enabling guidance from either the instant disclosure or the art, and the breath and diversity of the embodiments encompassed by the claimed genus, the limited working examples, and the level of the art at the time of the invention, one of ordinary skill in the art must rely on undue trial and error experimentation to make and test the numerous recombinant chromosomal segments, in order to make and/or use the invention within the full scope of these Claims.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
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 the presence of both marker sequences flanking the recombinant chromosomal segment.
Conclusion
Claims 1, 4-7, 22-25 and 27 remain rejected.
Finality
THIS ACTION IS MADE FINAL. 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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