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 .
DETAILED ACTION
Election/Restriction
1. Applicant’s response filed in the papers of April 24, 2026 is acknowledged and entered. In response to Applicant’s arguments and upon further consideration, the restriction requirement between SEQ ID NO: 10 and SEQ ID NOs: 1-9 is withdrawn.
Applicants are advised that if any claims including all the limitations of an allowable claim examined here are presented in a continuation or divisional application, such claims may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the
inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Status of objections and rejections
2. Claims 1, 2, 29, 41, 42, 50, 54, 55, 58, 98-107 are pending. Claims 3-28, 30-40, 43-49, 51-53, 56-57 and 59-97 were previously cancelled by the Applicant. Claims 100 and 106-107 directed to non-elected subject matter were previously withdrawn from further consideration. Accordingly Claims 1, 2, 29, 41, 42, 50, 54, 55, 58, 98, 99 and 101-105 in conjunction with the SEQ ID NOs: 1-10; and species corn event Zm_CSM63715 are examined on merits in the present examination.
3. Objections to claims 1, 50, 54, 58 and 104 are withdrawn in light of Applicant’s arguments, claim amendments filed in the papers of April 24, 2026, and upon further consideration.
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
5. Rejection of Claim 50 under 35 U.S.C. 112(b), as being indefinite is withdrawn in light of Applicant’s arguments, claim amendments filed in the papers of April 24, 2026, and upon further consideration.
6. Rejection of claims 2, 29, 58, 98, 103 and 104 under 35 U.S.C. 112(a), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s arguments, claim amendments filed in the papers of April 24, 2026, and upon further consideration.
7. Rejection of claims 98 and 104 under 35 U.S.C. 102(a)(1)as being anticipated by Jakel et al. (US Patent NO. 6,610,867 B2, Issued August 26, 2003) is withdrawn in light of Applicant’s arguments, claim amendments filed in the papers of April 24, 2026, and upon further consideration.
Claim Rejections - 35 USC § 112
8. Claims 1, 2, 29, 41, 42, 50, 54, 55, 58, 98, 99 and 101-105 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(s), at the time the application was filed, had possession of the claimed invention. This rejection was also necessitated in response to Applicant’s arguments and interview of April 28, 2026.
The Federal Circuit has recently clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id.
Finally, the court held:
A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. Id.
See also MPEP Section 2163, page 174 of Chapter 2100 of the August 2005 version, column 1, bottom paragraph, where it is taught that
[T]he claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
See also Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1016 at 1021, (Fed. Cir. 1991) where it is taught that a gene is not reduced to practice until the inventor can define it by "its physical or chemical properties" (e.g. a DNA sequence).
Claims are broadly drawn to 90% to 99.9% identity to SEQ ID NO: 10 or SEQ ID NO: 9, and a complete complement thereof.
The instant specification, however, describes full-length sequence of SEQ ID NO: 9 and SEQ ID NO: 10.
The claims encompass a broadly claimed genus having structures (species) with unknown or unpredictable function. The specification fails to describe representative structures as encompassed by the breadth and scope of instantly claimed methods. Thus, their function is either unknown or unpredictable.
There is no description of the structure required for the recited function, and no description of the necessary and sufficient elements of functional activity of SEQ ID NOs : 9 and 10. Applicant’s broadly claimed genus encompasses structures whose function is unrelated to the instantly claimed SEQ ID NOs: 9 and 10.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, SEQ ID NOs: 9 and 10 are insufficient to describe the claimed genus.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
Given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing.
Conclusion
9. No claims 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 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 Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA).
/VINOD KUMAR/Primary Examiner, Art Unit 1663
Prosecution Insights