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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 7-13, 16-23, 25 and 67-79 in the reply filed on 13 March 2026 is acknowledged.
Claims 4-6, 14-15, 24, 26-33, 39-45 and 57-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 13 March 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 7-13, 16-23, 25 and 67-79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 18/055,019. Although the claims at issue are not identical, they are not patentably distinct from each other because the corn plant and plant part comprising corn event DP-910521-2 of the copending Application renders obvious the instantly claimed corn seed, corn plant and parts thereof comprising corn event DP-910521-2 of the instant Application. The claims of the instant Application and those of the co-pending Application substantially overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The Examiner notes that the instant Application and the co-pending Application claim benefit of the same two U.S. Provisional Application and thus have the same priority date.
Claim Rejections - 35 USC § 112
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 8-13, 16-23, 25 and 67-79 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 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.
The invention appears to employ novel plants. Since the plant is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the plant. A deposit of 650 seeds of each of the claimed embodiments is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the plant and it is not apparent if the plant is readily available to the public. It is noted that Applicants have deposited the plant but there is no indication in the specification as to under what conditions the deposit was made and accepted or an affirmative statement about public availability.
(a) If a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention has been deposited and accepted, and will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
Applicant’s statement on page 6, lines 4-28, do not state as to under what conditions the deposit was made and accepted. Applicant merely states that the deposit(s) will be maintained under the terms of the Budapest Treaty. As stated above if the deposit was not made and accepted under the terms of the Budapest Treaty then Applicant needs to make a viability statement of record.
Claims 7, 16-23, 72, 73 and 75-79 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 a plant and parts thereof comprising corn event DP-910521-2, does not reasonably provide enablement for a plant/corn plant comprising random DNA fragments of corn event DP-910521-2 such as instant SEQ ID NO: 21, 26 or 29, for example. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Applicant claims a plant comprising a DNA sequence at least 95% identical to SEQ ID NO: 21. Applicant claims a plant/seed/corn plant/biological sample/extract comprising a nucleotide sequence of SEQ ID NO: 26 or 29. Applicant claims a biological sample derived from a corn plant comprising corn event DP-910521-2, but claims 72, 73 and 75-79 do not recite that corn event DP-910521-2 is present in the sample.
Applicant teaches a corn plant comprising corn event DP-910521-2, the insert being instant SEQ ID NO: 2, instant SEQ ID NO: 3 comprising SEQ ID NO: 2 and the 3’ and 5’ genomic flanking sequences.
Applicant does not teach how to make and use plants/corn plants comprising fragments of corn event DP-910521-2 as broadly claimed.
In re Wands, 858F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) lists eight considerations for determining whether or not undue experimentation would be necessary to practice an 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 claims.
Instant SEQ ID Nos. 21 (108bp), 26 (10bp) and 29 (10bp) do not appear to have an innate function or use other than as primers for identifying a corn plant comprising corn event DP-910521-2. Further, Applicant has only taught a corn plant comprising instant SEQ ID NO: 21. At instant claims 69-79, there is not apparent requirement that the product comprise corn event DP-910521-2. If the plant of claim 67 is heterozygous for corn event DP-910521-2 than parts such as pollen would not necessarily comprise corn event DP-910521-2. Hence, it would have required undue trial and error experimentation to make and use the invention as broadly claimed.
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.
Claims 8, 12, 13, 25, 68, 69, 70 and 71 are 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.
At claim 8, “A corn event DP-910521-2” is indefinite because it is unclear if the claim is directed to a corn plant represented by the deposited seed or if the claim is directed to an isolated polynucleotide. Hence, the metes and bounds of the claim are unclear.
At claims 12, 13, 70 and 71 are indefinite because it is unclear if the limitation “transgenic” refers to the recited sequence recited in the claim they depend from or if the seed or corn plant can comprise any transgene. Hence, the metes and bounds of the claims are unclear.
Claim 25 is indefinite because claim 20, upon which it depends, is not directed to a method. Hence, the metes and bounds of the claim are unclear.
At claim 68, 99% identical to SEQ ID NO: 21 is indefinite because SEQ ID NO: 3 at claim 67 comprises SEQ ID NO: 21 and thus 99% identity to 99% identity fails to set forth the metes and bounds of the claimed invention.
At claim 69, “the seed of claim 67” lacks proper antecedent basis in claim 67. Hence, the metes and bounds of the claim are unclear.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 11-13, 16-23 and 69-79 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over GenBank Accession No. EU941770 (2008, www.ncbi.nlm.nih.gov/nuccore/ EU941770).
The claims are drawn to corn plants and parts thereof produced from plants with the DP-910521-2 event, wherein the claimed plants and seeds comprise a nucleotide sequence of SEQ ID NO:26. As the claimed plants and seeds are not required to have the event, these claims are treated as products by process.
Corn plants and/or seeds comprising at least mRNAs comprising the sequences It is not clear if the mRNA was taken from plants or seeds and if the corn genome comprises DNA comprising SEQ ID NO:26.
EU941770/c
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
LOCUS EU941770 108 bp mRNA linear PLN 29-OCT-2008
DEFINITION Zea mays clone 1470005 mRNA sequence.
ACCESSION EU941770
VERSION EU941770.1
KEYWORDS FLI_CDNA.
SOURCE Zea mays
ORGANISM Zea mays
Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
Spermatophyta; Magnoliopsida; Liliopsida; Poales; Poaceae; PACMAD
clade; Panicoideae; Andropogonodae; Andropogoneae; Tripsacinae;
Zea.
REFERENCE 1 (bases 1 to 108)
AUTHORS Alexandrov,N.N., Brover,V.V., Freidin,S., Troukhan,M.E.,
Tatarinova,T.V., Zhang,H., Swaller,T.J., Lu,Y.P., Bouck,J.,
Flavell,R.B. and Feldmann,K.A.
TITLE Insights into corn genes derived from large-scale cDNA sequencing
JOURNAL Plant Mol. Biol. 69 (1-2), 179-194 (2009)
PUBMED 18937034
REFERENCE 2 (bases 1 to 108)
AUTHORS Alexandrov,N.N., Brover,V.V., Freidin,S., Troukhan,M.E.,
Tatarinova,T.V., Zhang,H., Swaller,T.J., Lu,Y.-P., Bouck,J.,
Flavell,R.B. and Feldmann,K.A.
TITLE Direct Submission
JOURNAL Submitted (04-AUG-2008) Ceres, Inc., 1535 Rancho Conejo Blvd.,
Thousand Oaks, CA 91320, USA
FEATURES Location/Qualifiers
source 1..108
/organism="Zea mays"
/mol_type="mRNA"
/db_xref="taxon:4577"
/clone="1470005
Query Match 100.0%; Score 10; Length 108;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AAGAGGGTAC 10
||||||||||
Db 17 AAGAGGGTAC 8
Claims 11-13, 16-23 and 69-79 are rejec;ted under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over GenBank Accession No. EZ106328 (2010, www.ncbi.nlm.nih.gov/nuccore/EZ106328).
The claims are drawn to corn plants and parts thereof produced from plants with the DP-910521-2 event, wherein the claimed plants and seeds comprise a nucleotide sequence of SEQ ID NO:29. As the claimed plants and seeds are not required to have the event, these claims are treated as products by process.
Corn plants and/or seeds comprising at least mRNAs comprising the sequences. It is not clear if the mRNA was taken from plants or seeds and if the corn genome comprises DNA comprising SEQ ID NO:29.
EZ106328/c
LOCUS EZ106328 96 bp mRNA linear TSA 09-JUN-2010
DEFINITION TSA: Zea mays contig41986, mRNA sequence.
ACCESSION EZ106328
VERSION EZ106328.1
DBLINK BioProject: PRJNA36555
Sequence Read Archive: SRX003329
KEYWORDS TSA; Transcriptome Shotgun Assembly.
SOURCE Zea mays
ORGANISM Zea mays
Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
Spermatophyta; Magnoliopsida; Liliopsida; Poales; Poaceae; PACMAD
clade; Panicoideae; Andropogonodae; Andropogoneae; Tripsacinae;
Zea.
REFERENCE 1 (bases 1 to 96)
AUTHORS Vega-Arreguin,J.C., Ibarra-Laclette,E., Jimenez-Moraila,B.,
Martinez,O., Vielle-Calzada,J.P., Herrera-Estrella,L. and
Herrera-Estrella,A.
TITLE Deep sampling of the Palomero maize transcriptome by a high
throughput strategy of pyrosequencing
JOURNAL BMC Genomics 10, 299 (2009)
PUBMED 19580677
REMARK Publication Status: Online-Only
REFERENCE 2 (bases 1 to 96)
AUTHORS Vega-Arreguin,J.C., Ibarra-Laclette,E., Jimenez-Moraila,B.,
Martinez,O., Vielle-Calzada,J.P., Herrera-Estrella,L. and
Herrera-Estrella,A.
TITLE Direct Submission
JOURNAL Submitted (23-MAR-2009) Cinvestav Campus Guanajuato, Laboratorio
Nacional de Genomica para la Biodiversidad, Km 9.6 Libramiento
Norte, Carretera Irapuato-Leon, Irapuato, Guanajuato 36821, Mexico
FEATURES Location/Qualifiers
source 1..96
/organism="Zea mays"
/mol_type="mRNA"
/db_xref="taxon:4577
Query Match 100.0%; Score 10; Length 96;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GCGCCAGTAG 10
||||||||||
Db 47 GCGCCAGTAG 38
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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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/David H Kruse/
Primary Examiner, Art Unit 1663