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 1-2, 4-11, 13-14, and 17-24 are pending and examined on the merits.
Claims 21-24 are newly presented.
Claims 1, 2, 4, 6, 13, 14, and 18-20 are currently amended.
Response to Arguments - Claim Objections
Applicant’s amendments filed 15 December 2025 have overcome the objection of record.
Response to Arguments - Indefiniteness
Applicant’s amendments filed 15 December 2025 have overcome the rejection of record.
Response to Arguments - Scope of Enablement – How to Use
Applicant’s amendments filed 15 December 2025 have overcome the rejection of record.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-11, and 14, 17-20 remain rejected and claims 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bentolila et al 1991 (Theoretical and Applied Genetics 82: p.393-398), and further in view of Liu et al 1999 (PNAS 96: p. 6535-6540) and Hoffbeck (US 6720487 B1).
Bentolila et al teach that there is tight linkage between the UMC150B marker and the Ht1 gene which is known to provide resistance to Northern Leaf Blight (Abstract and entire document). They further state that this known linkage could be used a starting point to clone the Ht1 gene (Conclusion).
Bentolila et al do not teach the sequence of the HT1 gene.
Liu et al teach the use of transformation-competent artificial chromosome (TAC) vectors to accelerate positional cloning of a gene whose physical location is imprecisely known. The TAC vectors are used to clone large segments of chromosomal DNA near locus of interest in order to use the vectors to transform plants for complementation studies (See entire document). These vectors also comprise heterologous sequences including sequences encoding a selectable marker which easily could be substituted for one of the known herbicide resistance genes (Figure 1).
Hoffbeck teaches that maize variety PH4GP has above average resistance to Northern Leaf Blight, both as an inbred and in hybrid combination (Column 14, lines 27-36).
At the time of filing, it would have been prima obvious for a person of ordinary skill in the art to clone the genomic region UMC150B marker in the vectors of Liu et al and use them to transform corn plant in an effort to clone to the Ht1 gene as suggested by Bentolila et al. Moreover, a person of ordinary skill in the art, would have been motivated to use genomic DNA from maize variety PH4GP as starting material for the Ht1 cloning process as Hoffman teaches that PH4GP has above average resistance to Northern Leaf Blight, both as an inbred and in hybrid combination (which suggests that the Ht1 resistance allele is dominant). In generating, the vectors to practice the of Liu et al to clone a gene whose physical location is imprecisely known, a person of ordinary skill in the art would have generated the claimed nucleic acid sequences and would have necessarily practiced the claimed methods, as the PH4GP is the source of the claimed Ht1 resistance gene. As such, claim(s) 1-2, 4-11, and 14, 17-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bentolila and further in view of Liu et al and Hoffbeck.
Response to Arguments - Claim Rejections - 35 USC § 103
Applicant's arguments filed 15 December 2025 have been fully considered but they are not persuasive.
Applicant urges the fact pattern is analogous to the PTAB decision Appeal No. 2021-003802 in which The Office was reverse on its obviousness rejection.
This argument is not persuasive, because while to cases share some similarities, the differences between the cases are critical. The appealed obviousness rejection contended that the it would have been obvious to specifically identify the gene via map-based cloning methods. The instant rejection contends that it would have been obvious to generate a genome library in the TAC vectors of Liu from maize variety PH4GP. Once the library is generated, vectors within the scope of the claims would have existed. Most of the claims do not actually require that the gene set forth in SEQ ID NOs:1 or 2 ever be identified specifically. It is suggested that the claims all be amended to a heterologous control element be operably linked to SEQ ID NOs:1 or 2 or a sequence encoding SEQ ID NO:3. This limitation would have required that specific identification of the gene conferring NLB resistance had occurred; thus, making the instant fact analogous to PTAB decision Appeal No. 2021-003802. If Applicant makes such an amendment, note that many dependent claims will need amendments to make them comply with 35 USC 112(b) and 112(d).
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 1-2, 4-11, 13 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20, 27, and 32 of copending Application No. 17404109 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims contemplate methods and products using or comprising the same genome locus encoding SEQ ID NO:8 which is identical to instant SEQ ID NO:3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5, 6 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32 of copending Application No. 18041714 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claim is drawn to the corn plant comprising a modified genome locus encoding SEQ ID NO:8 which is identical to instant SEQ ID NO:3. The constructs used to make the corn plant and the corn plants of the instant claims are obvious over the pending claim 32.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments - Double Patenting
Applicant's arguments filed 15 December 2025 have been fully considered but they are not persuasive.
Applicant urges the copending applications have a later filing date than the instant application and thus the rejection should not be maintained as no other rejections are pending.
This argument is not persuasive, because several claims are still rejected as being obvious over the prior art of record.
Claim Objections
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed. 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 extension fee 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 MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663