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
1. Applicant’s amendments to claims 1, 4, 5, 8 and 9, cancellation of claims 2, 3, 6, and 7 as well as submission of new claims 16 and 17 in the paper filed 6/12/2025 are acknowledged.
Claims 13-15 are withdrawn for being drawn to non-elected invention.
Claims 1, 4-5, 8-12 and 16-17 and BYV, BMYV as well as SEQ ID NO: 1 and 2 are examined on the merits.
2. The rejections and objections not recited in this action are withdrawn.
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.
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.
3. Claims 4-5 and 16-17 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.
In claim 4, the recitation “the sense and/or antisense sequence(s) each have a length of at least 25 nt to at least 4000 nt” renders the claim indefinite. It is unclear such limitation is to broaden the independent claim 1 or further limit it given that the SEQ ID NO:1 and 2 has a fixed length of 440 bp and 450 bp, respectively . The metes and bounds are not clear.
In claim 5, the recitation “the sense and/or antisense sequence(s) each have a length of at least 50 nt to at least 2000 nt” renders the claim indefinite. It is unclear such limitation is to broaden the independent claim 1 or further limit it given that the SEQ ID NO:1 and 2 has a fixed length of 440 bp and 450 bp, respectively . The metes and bounds are not clear.
In claim 16, the recitation “the sense and/or antisense sequence(s) each have a length of at least 100 nt to at least 1000 nt” renders the claim indefinite. It is unclear such limitation is to broaden the independent claim 1 or further limit it given that the SEQ ID NO:1 and 2 has a fixed length of 440 bp and 450 bp, respectively . The metes and bounds are not clear.
In claim 17, the recitation “the sense and/or antisense sequence(s) each have a length of at least 300 nt to at least 600 nt” renders the claim indefinite. It is unclear such limitation is to broaden the independent claim 1 or further limit it given that the SEQ ID NO:1 and 2 has a fixed length of 440 bp and 450 bp, respectively . The metes and bounds are not clear.
Written Description
4. Claims 1, 4-5, 8-12 remain and claims 16-17 are rejected under 35 U.S.C. 112, 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.
After reviewing the language of instant claims, it is concluded that obtaining construct expressing sense strand alone (emphasis added) that can confer beta plant resistance to BYV and BMYV; or an RNA molecule formed upon transcription of the construct according to claim1 is essential for practice the invention.
.
The specification teaches silencing constructs comprise dsRNA targeting SEQ ID NO:1 and 2 regions are effective to confer resistance to BYV and BMYV respectively (Table 2). The specification further constructed silencing vectors targeting BYV_CDS7, BMYV_P3/P4, BCTV_C4/Rep, BSCTV_ C4/Rep, BNYVV_CP regions to confer resistance to BYV, BMYV, BCTV, BSCTV and BNYVV (Figures 5-14).
First, Applicants do not describe any sense strand alone that can be used to practice instant invention, needless to say the size could be as short as 25 bp. The specification only describes silencing construct using dsRNA targeting SEQ ID NO:1 and 2, which has size of 400-500 bp. Although transgene suppression could possiblely be used in plant, such method would be unpredictable in term of the location of the insertion, size of the transgene and regions used for transgene. Without any further description, Applicants are not in possession of sequence comprising the sense strand alone for providing the resistance to BYV and BMYV
The Federal Circuit has recently clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In summary, the court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. The court goes on to say, “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 of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Applicants fail to describe a representative number of constructs expressing sense only strand that can confer beta plant resistance to BYV and BMYV. Applicants only describe silencing constructs comprise dsRNA targeting SEQ ID NO:1 and 2 regions are effective to confer resistance to BYV and BMYV respectively. Furthermore, Applicants fail to describe structural features common to members of the claimed genus of constructs. Hence, Applicants fail to meet either prong of the two-prong test set forth by Eli Lilly. Furthermore, given the lack of description of the necessary elements essential for silencing construct, it remains unclear what features identify a species. Since said genus has not been described by specific structural features, the specification fails to provide an adequate written description to support the breath of the claims.
Applicants traverse in the paper filed 6/12/2025. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants argue that claims as amended overcome the rejection (response, page 11).
The Office contends that claims as amended still reads on using sense strand only to confer the resistance.
Conclusion
No claim is allowable.
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 LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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/LI ZHENG/Primary Examiner, Art Unit 1662