Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-18 are pending.
Election/Restrictions
Applicant's election with traverse of the nucleotide sequence of SEQ ID NO: 78 as species election in the reply filed on 03/13/2026 is acknowledged. The traversal is on the ground(s) that Applicant submits that SEQ ID NO: 77 contains the elected species SEQ ID NO: 78 and that no additional search is required for the examination of SEQ ID NO: 77 and 78 together in this application. This is found persuasive. Therefore, SEQ ID NO: 77 is hereby rejoined with SEQ ID NO: 78. Claims 1-18 drawn to SEQ ID NO: 77 and 78 will be examined in this application.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Claims 1-18, pending in this application, are examined.
Claim Objections
Claims 14 and 18 are objected to because of the following informalities:
at claims 14 and 18,it is suggested that ---, the method---, be inserted before “comprising”.
At claim 18, it is suggested that ---the--- be inserted after cultivating.
Appropriate correction is required.
Improper Markush Grouping Rejection
Claims 1-18 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of SEQ ID NO: 1-158 and 180-183 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The nucleotide sequences of SEQ ID NO: 1-158 and 180-183 do not share a common structure and function as the sequences include intron sequences, promoter sequences, and leader sequences. For example, the elected sequence of SEQ ID NO: 78 is a promoter sequence, while SEQ ID NO: 3, 20, 35, 43, 47, 51, 57, 61, 67, 71 and 81 are leader sequences, SEQ ID NO: 4, 7, 21, 24, 36, 44, 48, 52, 54 are intron sequences, and SEQ ID NO: 89 is an enhancer sequence. In addition, the sequences including the promoter sequences, intron sequences, and leader sequences vary in length and are not fragments to each other, according to the sequence listing. Therefore, the sequences of SEQ ID NO: 1-158 and 180-183 do not share a common structure and function with each other or with the elected sequence of SEQ ID NO: 77-78.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 USC 134 and 37 CFR 41.31 (a)(1).
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 1-18 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 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.
The claims are broadly drawn to a genus of nucleotide sequences that shares 85%, 90% or 95% identity to SEQ ID NO: 77 or 78, or a fragment of any size of SEQ ID NO: 77 or 78 having gene regulatory activity. The nucleotide sequence of SEQ ID NO: 77 contains the promoter sequence of SEQ ID NO: 78, the intron sequence of SEQ ID NO: 72, and the leader sequence of SEQ ID NO: 71. Therefore, a nucleotide sequence that shares 85% or 90% identity to SEQ ID NO: 77 includes a genus of sequences with unspecified mutations (additions, deletions and/or substitutions) to the 680 nucleotide long promoter sequence of SEQ ID NO: 78 and to the 1810 nucleotide long sequence of SEQ ID NO: 77 that may or may not retain regulatory activity. Claims 1-3, for example, the sequences that share 85%, 90% or 95% to SEQ ID NO: 77 and 78 do not require to retain gene regulatory activity. Further, the scope of the claims encompasses a genus of fragments of any size of SEQ ID NO: 77 and 78 having gene regulatory activity.
In contrast, the specification describes SEQ ID NO: 78 (as the elected species) having promoter activity and the EXP sequence comprising the promoter sequence of SEQ ID NO: 78, the intron sequence of SEQ ID NO: 72, and the leader sequence of SEQ ID NO: 71. The specification contemplates expression of a transgene (GUS or RLuc) driven by SEQ ID NO: 78 in corn leaf protoplast cells plants for higher transgene expression level relative to CaMV 35 S promoter.
The specification, however, fails to describe a single nucleotide sequence having unspecified mutations (or internal deletion/substitution/addition) of SEQ ID NO: 77 or 78 that resulted in sequences having 85%, 90% or 95% identity thereto. The sequences that share 85%, 90% or 95% to SEQ ID NO: 77 or 78 of claims 1-3 do not require to retain gene regulatory activity while the sequences of claim 4 require gene regulatory activity. The specification, however, fails to describe the structural features that would distinguish gene regulatory sequences that share 85%, 90% or 95% to SEQ ID NO: 77 or 78 from other sequences that share 85%, 90% or 95% to SEQ ID NO: 77 or 78. The specification also fails to describe which nucleotide/region in SEQ ID NO: 77 or 78 would tolerate mutations to retain the gene regulatory activity. The specification further fails to describe a single fragment of SEQ ID NO: 77 or 78 that retains regulatory activity. There is no description of the structure and size of the fragments of SEQ ID NO: 77 or 78. Therefore, the genus of sequences that share 85%, 90%, and 95% to SEQ ID NO: 77 or 78 or fragments thereof are highly variable. The function claimed sequences having structural identity of 85%, 90% or 95% having no known function are highly variable. In addition, the specification fails to describe structural features common to members of the claimed genus of sequences . Therefore, the specification has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly 119 F.3d at 1568, 43 USPQ2d at 1406, and has not shown her/his possession of the claimed genus at the time of the application. Therefore, the instant specification does not describe the claimed genus.
Since the specification fails to sufficiently describe the claimed sequences that share 85%, 90%, and 95% to SEQ ID NO: 77 or 78 or fragments thereof of any size or length , transgenic plant/cell/seed and commodity comprising said sequences and methods that employ with said sequences for expression of transcribable polynucleotides are similarly not described.
MPEP 2163 and related case laws state that the written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See E/i Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Therefore, for all the reasons discussed above, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1 and 4-18 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Wu et al (US 7,750, 207).
The claims are drawn to a DNA molecule comprising a fragment of any size of SEQ ID NO: 77 or 78 having gene regulatory activity that is operably linked to a heterologous encoding nucleotide sequence, a transgenic plant or part thereof comprising said DNA molecule, and a method of expressing said heterologous encoding sequence in a transgenic plant.
The “gene regulatory activity” is defined in the instant specification [0032] as “the ability to affect the expression pattern of an operably linked transcribable polynucleotide molecule by affecting transcription and/or translation of that operably linked transcribable polynucleotide molecule”. According to the specification, SEQ ID NO: 78 and 77 comprise a promoter sequence which further comprises cis-elements, core promoter or TATA box having a gene regulatory activity.
Wu et al teach a DNA molecule comprising a plant promoter and leader sequence operably linked to a transcribable heterologous nucleotide sequence, a transgenic plant/seed and progeny thereof comprising said DNA molecule, and a method of producing said transgenic plant/seed or progeny by expressing said DNA molecule in a plant; said plant is a monocot or a dicot and; seed produced by the plant and a protein product expressed in the plant are considered commodity products (see at least the claims). Therefore, given the broad scope of a “fragment” of any size/length and the definition of the “gene regulatory activity”, Wu et al teach “a fragment” of SEQ ID NO: 77 or 78 (see the alignment of sequences shown below). Therefore, Wu et al anticipate the claimed invention.
RESULT 118
US-11-514-704-18494
Sequence 18494, US/11514704
Patent No. 7750207
GENERAL INFORMATION
APPLICANT: MONSANTO TECHNOLOGY, LLC
APPLICANT: Wu, Kunsheng
APPLICANT: Dasgupta, Santanu
APPLICANT: Cherian, Shoba
APPLICANT: Jayaprakash, Targolli L
TITLE OF INVENTION: Zea mays Ribulose Bisphosphate Carboxylase
TITLE OF INVENTION: Activase Promoter
FILE REFERENCE: 38-21(53660)C
CURRENT APPLICATION NUMBER: US/11/514,704
CURRENT FILING DATE: 2006-09-01
NUMBER OF SEQ ID NOS: 25043
SEQ ID NO 18494
LENGTH: 1885
TYPE: DNA
ORGANISM: Zea mays
FEATURE:
NAME/KEY: misc_feature
LOCATION: (1869)..(1869)
OTHER INFORMATION: n is a, c, g, or t
Query Match 2.8%; Score 19; Length 1885;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 298 GCCGAGGTGGTGGTGGCCC 316
|||||||||||||||||||
Db 449 GCCGAGGTGGTGGTGGCCC 431
Conclusion
Claims 2-3 are deemed free of the prior art of record.
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/
Primary Examiner, Art Unit 1662