Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim status
Claims 1-5, 8-9 and 16-20 are pending and examined on the merits in the present Office action.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/IB10/01766, filed on 6/30/2009.
Election/Restrictions
Applicant’s election of bHLH101 in the reply filed on 6/12/2023 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant responded by electing SEQ ID NO: 79-83; however, the requirement for election of species on 5/5/2023 was for a single species. In a telephone interview on 8/2/2023, Attorney Kozakiewicz elected SEQ ID NO: 83.
Newly added claims 18-20 are examined on the merits in the present Office action.
Claim Rejections - 35 USC § 112
Written Description
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.
Claims 1-5, 8-9 and 16-17 remain rejected and claims 18-20 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 claims contain 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Due to Applicant's amendment of the claims, this rejection is modified from the rejection set forth in the Office action mailed 6/3/2025, as applied to claims 1-5, 8-9 and 16-17.
Applicant claims a method of producing a heat stress tolerant plant by transforming any species of plant with a construct comprising a bHLH101, growing said plant and selecting a plant having increased heat stress tolerance. Claims 4-5, 8-9 and 16-17 limit the bHLH101 to specific sequences; however, the scope of the plant which is produced are broadly drawn to any plant species. Claim 18 limits the plant to a dicot. Claim 19 limits the plant to a Markush group of genera. Claim 20 limits the plant to Glycine max.
Applicant has described constitutive expression of bHLH101 increasing heat stress tolerance (Examples 12 and 13) wherein it appears Applicant only observed expression of a single sequence of bHLH101 using only a constitutive promoter and only in Arabidopsis thaliana.
Applicant has not described expressing a bHLH101 gene in any plant other than Arabidopsis thaliana. Applicant has not described a representative number of species across the claimed genus of plants nor a structure which can be expected to provide the claimed function in any plant species.
Wang et al. (Wang et al. Molecular Plant. 6(2):503-513. 2013) teaches that a function of bHLH101 is regulation of iron deficiency response and uptake (abstract). Wang et al. teaches that there are two basic strategies of iron acquisition in plants. The grass family of plants, Gramineae, i.e., Poaceae, uses chelation, known as “strategy II”, whereas all other plants, e.g., Arabidopsis, use reduction, known as strategy I (page 503, paragraph 1). Wang et al. teaches that Arabidopsis is a model plant for studying iron uptake in strategy I plants (page 503, paragraph 2). While the instantly claimed invention is drawn to heat stress tolerance, one of ordinary skill in the art would recognize that overexpression of bHLH101 would not necessarily have the same effect in all plants given that bHLH101 is involved in a process that is not conserved between major groups within the plant kingdom. One of ordinary skill in the art would not be able to envision which members of the claimed genus would be capable of being selected for having increased heat stress tolerance relative to a wild type control.
Therefore, given the limited working examples and a lack of description of the structure required to be able to select a plant of any species for increased heat stress tolerance wherein a bHLH101 has been introduced for heat stress tolerance to any plant, one of ordinary skill in the art would not have recognized Applicant to be in possession of the claimed invention.
Applicant’s arguments regarding rejection under 35 USC 112(a) for failing to comply with written description requirement
Applicant's arguments filed 8/29/2024 have been fully considered but they are not persuasive.
Applicant argues on pages 4-6 that the Specification recites expressing a BHLH101 gene in any plant species including 64 explicitly recited genera as well as vectors for expressing a bHLH101 gene and identification of homologs of Arabidopsis bHLH101b by searching databases for similar sequences and that exemplary sequences encoding a bHLH101 gene from a variety of plants, i.e. SEQ ID NO: 79-83. Therefore, Applicant argues, one of ordinary skill in the art would readily appreciate which sequences can be expected to provide the claimed increase in heat stress tolerance relative to a wild-type control.
This argument has been fully considered but it is not persuasive. The contemplation of these embodiments is merely prophetic. While Applicant is not required to reduce to practice every embodiment encompassed within the scope of the claimed invention, the reduction to practice of a single embodiment does not sufficiently provide a representative number of species across the broad genera claimed nor a structure that would allow one of ordinary skill in the art to envision which members of the genus would possess the claimed function.
Applicant argues on pages 6-9 that while the only embodiment of the claimed invention reduced to practice is a single sequence of bHLH using only a constitutive promoter and only in Arabidopsis thaliana, this is sufficient such that one of ordinary skill in the art that the inventor possessed the invention and enabled one to make and use the invention without undue experimentation. Applicant argues that the teachings of Wang, that different groups of plants have different strategies of iron uptake associated with bHLH101 expression, are not relevant because the activity of bHLH101 occurs after the mechanisms of iron deficiency occur that are known to be different across plant groups and that bHLH101 interacts with another unknown factor which is constitutively expressed. Therefore, Applicant argues, the teachings of Wang do not support that the iron uptake activity would be affected by differences in plant groups, nor that bHLH101 is in any way associated with other stress responses, let alone heat stress tolerance. Applicant argues that the discovery of heat stress tolerance associated with the bHLH101 polypeptide in Arabidopsis by itself provides strong evidence that bHLH101 polypeptides in other plant species possess the same function and that one of ordinary skill in the art would recognize Applicant is in possession of the claimed invention.
This argument has been fully considered but it is not persuasive. The teachings of Wang were presented to demonstrate that a known function of bHLH101 differs in different plants. Therefore, despite that function not being the claimed function, one of ordinary skill in the art would not be able to envision which members of the would comprise the claimed function because the instant disclosure does not sufficiently provide a representative number of species across the broad genera claimed nor a structure that would allow one of ordinary skill in the art to envision which members of the genus would possess the claimed function and the knowledge in the art does not overcome that deficiency.
Examiner’s statement of closest prior art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Abad (US20080148432) teaches Arabidopsis thaliana protein ATZ58074, SEQ ID NO: 44,398, which shares 100% identity with instantly claims SEQ ID NO: 84. Abad teaches a method of integrating recombinant DNA into a plant that exhibits increased water use efficiency, cold tolerance and other trait improvements. However, Abad does not make a teaching or suggestion that makes obvious selection for increased heat tolerance.
Conclusions
Claims 1-5, 8-9 and 16-20 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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, Joe Zhou can be reached on (571) 272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID R BYRNES/Examiner, Art Unit 1662
/SHUBO ZHOU/
/SHUBO (JOE) ZHOU/Supervisory Patent Examiner, Art Units 1661 and 1662