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. Claims 1-16 are pending.
Election/Restrictions
2. Applicant's election with traverse of Group I, claims 1-2 and 8, and SEQ ID NO: 1 as species election in the reply filed on 5/18/2026 is acknowledged.
Applicants argue after amendments, claims 1-13 share a common technical feature of SEQ ID NO:1, which is novel (response, page 9) and that claims 14 to 16 define the transgenic soybean event DBN8205
The Office found applicants’ argument partially persuasive. As a result, claims 1-8 are examined together. However, Group V (i.e. claims 14-15) is drawn to an agricultural product which do not have to contain SEQ ID NO: 1, whereas Group IV (i.e. claims 9-13 and 16) is drawn to cell or plant comprising the soybean event DBN8205, which contains genome sequence comprising SEQ ID NO:1 rather than isolated SEQ ID NO:1.
It is also noted that SEQ ID NO:3 comprises SEQ ID NO:1, therefore it will be examined together.
Claims 9-16 are withdrawn for being drawn to non-elected inventions.
Claims 1-8 and SEQ ID NO:1 and 3 are examined on the merits.
The requirement is still deemed proper and is therefore made FINAL.
Specification
3. The abstract is objected to because it should be within the range of 50-150 words.
4. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. See, for example, page 30.
Claim Objection
5. Claim 7 is objected to for missing “and “ between last two steps.
Improper Markush Grouping
6. Claims 1-8 are rejected under the judicially-created basis that it contains an improper Markush grouping of alternative. See In re Harnisch, 631 F.2d 716, 721-722 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. and Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or common use that flows from the substantial structural feature and/or common use that flows from the substantial structural feature for the following reasons:
In claim 1, SEQ ID NO: 1/3 has distinct structure compared with SEQ ID NO: 2/4.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or groupings of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. 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.
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.
7. Claims 1-8 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 claims 1, 3, 5 and 7-8, the recitation “preferably” renders the claims indefinite. It is unclear the descriptions after it are considered as limitation or not. The metes and bounds are unclear.
In claims 3, 5 and 7-8, the recitation “nucleic acid sequence according to claim 1” renders the claims indefinite. The claim 1 is drawn to a nucleic acid molecule rather than nucleic acid sequence. It is unclear which nucleic acid sequence it refers to. The metes and bounds are not clear.
Scope of Enablement
8. Claims 5-8 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for SEQ ID NO: 1 being used as a probe for detecting the DBN8205 event, does not reasonably provide enablement for any larger sequence such as SEQ ID NO:3 or 5 comprising SEQ ID NO: 5. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
A review of the language of claims indicates that the claims are broadly drawn to a genus for a method for detecting DBN8205 event in a transgenic soybean plant using any sequence comprising SEQ ID NO:1.
The specification teaches unique junction sequence of SEQ ID NO:1.
However, it is well known in the art that probe does not need to be 100% identical to the sequence to hybridize to the target. Therefore, SEQ ID NO:3 having 634 bp would contain vector sequences that are not unique to DBN8205 event, needless to say the SEQ ID NO:5, which contains 12813 bp, would hybridize to any transgenic event in any plant if they share the same selection or vector sequences.
Therefore, given the claim breadth, lack of further guidance and additional working example, unpredictability of the art, undue experimentation would be required for a person skilled in the art to practice the invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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.
12. Claims1-2, and 4-10 are rejected under 35 U.S.C. 102(b) as being anticipated by Suzuki et al. (1993, Plant Mol. Biol. 21:109-119).
The instant claims are drawn to an expression cassette for regulating root specific/preferential expression in plant comprising functional equivalent of transcriptional regulating sequence of the gene At1g66280 operably linked to a heterologous sequence; or wherein the transcription regulating nucleotide sequence is a nucleotide sequence having substantial similarity with a sequence identity at least 40% to a transcription regulating nucleotide sequence described by SEQ ID NO: 1-4;or wherein expression of the nucleic acid sequence results in expression of a protein; or wherein expression of the nucleic acid sequence confers to the plant an agronomically valuable trait; or wherein the transcription regulating nucleotide sequence comprises a fragment of SEQ ID NO: 1-4. The instant claims are also drawn to a vector or a plant cell comprising the expression cassette.
The Office interprets the claims to encompass any root-specific/ preferential promoter, given the undefined term “substantial similarity”, the recitation “a transcription regulating nucleotide sequence described by SEQ ID NO: 1-4” , the broad interpretation of the term “functional equivalent”, as well as the undefined hybridization condition.
Suzuki et al. teach a vector containing a root specific promoter from soybean SbPRP1 gene operably linked to GUS gene (abstract, Figure 1 and page 110, the last paragraph of the left column) and transgenic tobacco expressing such vector. Without defining hybridization condition, functional equivalent, and substantial similarity, the claims read on any root-specific promoter. “Agronomically valuable trait” can be broadly interpreted as any trait, therefore GUS gene is considered to confer agronomically valuable trait. The reference thus meets all the limitations set forth by instant claims.
Conclusion
No claim is allowed.
However, instant claims are free from prior art for the failure of the prior art to teach or fairly suggest SEQ ID NO:1 or 3.
The closest prior art is US Patent Application Publication No. 2004/0123343, which teach SEQ ID NO: 10372 that is 85.5% identical to instant SEQ ID NO:1.
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
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