DETAILED ACTION
Claims 27 and 36-41 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The objection to claims 27 and 38-41 is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 27 and 36-41 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the subject matter that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 27, 36-38 and 41 under 35 U.S.C. 103(a) as being unpatentable over Boets et al (2006, US 7,361,808) in view of Shin et al (1995, Appl. Environ. Microbiol. 61:2402-2407) is withdrawn in light of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 27 and 36-40 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Neither the instant specification nor the originally filed claims appear to provide support for probes comprising or complementary to an oligonucleotide sequence derived from SEQ ID NO:3, 6, 9, 12, 14, 16, or 18 or a sequence that encoding a pesticidal protein with at least 98% identity to SEQ ID NO:2, 4, 7, 10, 13, 15, or 17.
The word “derive(d)” does not appear in the specification or originally filed claims in the context of nucleic acids or oligonucleotides. It only appears in the context of products derived from plants (original claim 23; ¶20, 55), transformed plants and seeds (¶101, 115, 117), proteins derived from TIC2199 (¶47, 62), organisms comprising TIC2199 (¶57, 92), or ferns (¶51), and an assay method (¶114).
The only recitations of “probe” appear in ¶24 and original claim 27, where the probe is only described as hybridizing with or homologous to or complementary to SEQ ID NO:3, 6, 9, 12, 14, 16, or 18 or a sequence that encoding a pesticidal protein with at least 98% identity to SEQ ID NO:2, 4, 7, 10, 13, 15, or 17. Thus, it does not provide support for an oligonucleotide sequence derived from SEQ ID NO:3, 6, 9, 12, 14, 16, or 18 or a sequence that encoding a pesticidal protein with at least 98% identity to SEQ ID NO:2, 4, 7, 10, 13, 15, or 17.
Thus, the claimed method using such probes constitutes NEW MATTER. In response to this rejection, Applicant is required to point to support for such probes or to cancel the new matter.
Claims 27 and 36-40 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 that 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 28 April 2026. Applicant’s arguments filed 5 May 2026 have been fully considered but they are not persuasive.
Claim 27 is drawn to a method of detecting nucleic acids of SEQ ID NO:3, 6, 9, 12, 14, 16, or 18 or that encode SEQ ID NO:2, 4, 7, 10, 13, 15 or 17 in a plant genomic DNA sample.
Claim 27 specifies that the probe hybridizes with recombinant nucleic acid molecule in plant genomic DNA, where the recombinant nucleic acid molecule comprises a nucleic acid encoding pesticidal proteins with 98% identity to SEQ ID NO:2, 4, 7, 10, 13, 15 or 17, where the probe comprises or is complementary to an oligonucleotide sequence derived from SEQ ID NO:3, 6, 9, 12, 14, 16, or 18 or a sequence that encoding a pesticidal protein with at least 98% identity to SEQ ID NO:2, 4, 7, 10, 13, 15, or 17, and where the probe does not hybridize with genomic DNA from an otherwise isogenic plant that does not comprise the recombinant nucleic acid molecule.
The claims thus require probes comprising or complementary to an oligonucleotide sequence derived from SEQ ID NO:3, 6, 9, 12, 14, 16, or 18 or a sequence that encoding a pesticidal protein with at least 98% identity to SEQ ID NO:2, 4, 7, 10, 13, 15, or 17.
The specification does not describe oligonucleotide sequences “derived from” SEQ ID NO:3, 6, 9, 12, 14, 16, or 18 or a sequence that encoding a pesticidal protein with at least 98% identity to SEQ ID NO:2, 4, 7, 10, 13, 15, or 17.
The structural features that distinguish oligonucleotide sequences “derived from” SEQ ID NO:3, 6, 9, 12, 14, 16, or 18 or a sequence that encoding a pesticidal protein with at least 98% identity to SEQ ID NO:2, 4, 7, 10, 13, 15, or 17 from other nucleic acids are not described in the specification.
The specification does not define what it means for an oligonucleotide sequence to be “derived from” from a given sequence. The plain meaning of the term encompasses probes that comprise part of the recited sequence and those that deviate from them in some unspecified amount.
The specification does not describe the full scope of these probes. Probes comprising part of the recited sequences encompass those that distinguish between genomes that comprise the recombinant nucleic acid molecule and those that do not and probes that cannot do so. The specification does not describe the structural features of probes comprising part of the recited sequences that make that distinction.
The specification does not describe the structural features of probes that deviate from the recited sequences in some unspecified amount and that distinguish between genomes that comprise the recombinant nucleic acid molecule and those that do not and probes that do not. It is not clear how different in sequence probes that “deviate from” the recited sequences are from the recited sequences themselves.
The specification does not describe any such probes.
Thus, other than nucleic acids of or complementary to SEQ ID NO:3, 6, 9, 12, 14, 16, or 18, the probes used in the method appear to be claimed and described solely by function.
Hence, Applicant has not, in fact, described the probes over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Arguments to the extent they apply to this modified rejection
Applicant urges that a person having ordinary skill in the art will understand that the reciliation in the claims defines the probes structurally (response pg 6).
This is not found persuasive. This merely unsupported attorney argument. Applicant has not explained what a person having ordinary skill in the art would understand the structure of the probes used in the method to be.
Claim 41 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham, can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Anne Kubelik/Primary Examiner, Art Unit 1663
Prosecution Insights