DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of SEQ ID NO:14 in the reply filed on June 23, 2026 is acknowledged.
Improper Markush Grouping
Claims 1-3 and 9, and claims 4-8 and 10-17 dependent thereon, are rejected on the judicially-created 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). 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 a common use that flows from the substantial structural feature for the following reasons: each of the sequences of SEQ ID NO: 1-19 and 26 appear to be structurally distinct in having different nucleotide sequences, and functionally distinct sequences in that each affects different expression patterns when used in a construct for plant transformation, as shown by the results set forth in Tables 1-10. 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.
Claims 1-17 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 drawn to a recombinant DNA molecule comprising a DNA sequence with at least 85% sequence identity to any of SEQ ID NOs:1-19 and SEQ ID NO: 26, or comprising any of SEQ ID NOs:1-19 and SEQ ID NO: 26, or a fragment of any of SEQ ID NOs:1-19 and SEQ ID NO: 26 that has gene-regulatory activity, wherein said DNA sequence is operably linked to a heterologous transcribable DNA molecule. The sequences of SEQ ID NOs:1-19 and 26 are 50 to 1300 nucleotides in length and are described as synthetic nucleotide sequences that affect transcription of operably linked coding sequences in the same manner as naturally occurring promoters, leaders, introns and 3’UTRs (page 27), and these sequences are identified as promoters, leaders, introns and 3’UTRs, and combinations of these sequences in Table 1 (page 29).
The specification discloses use of the recited sequences and combinations thereof, in constructs for plant transformation, and analysis of the expression of a heterologous gene. It is apparent from the results presented in Table 2 that there was minimal gene expression when there was no promoter in the construct, and there was varied gene expression depending on the particular choice of promoter, and presence of an intron or not. It is unclear whether any of the sequences of SEQ ID NOs:1-19 and SEQ ID NO: 26 operably linked to a heterologous gene, would on their own enhance gene expression, much less fragments of any of these sequences or sequences having as little as 85% sequence identity. Yet, Kim et al. (A 20 nucleotide upstream element is essential for the nopaline synthase (nos) promoter activity. Plant Mol. Biol. 1994 Jan;24(1):105-17) teach that as little as a 20 nucleotide sequence can be essential to promoter activity, and that point mutations can also significantly influence promoter strength (see the abstract, at least). In addition, results are presented that show different levels of expression in different plant tissues and developmental stages (see Table 7), while the claims do not recite any limitations with regard to the circumstances that affect the gene-regulatory activity of any of the claimed sequences.
The claims are drawn to a multitude of possible SEQ ID NOs and similar sequences, and fragments thereof that have gene regulatory activity in a recombinant DNA molecule operably linked to a heterologous transcribable sequence. Yet the specification only discloses particular SEQ ID NOs in combination with other specific sequences that have functional activity of regulating gene expression in plant cells or tissues. With regard to the elected sequence of SEQ ID NO: 14, this sequence was tested in a construct having a specific composition in a specific arrangement resulting in different levels of gene regulatory activity in leaf and root (Example 6 pages 45-44). The specification describes only one sequence structure (SEQ ID NO:14) and one type of gene regulatory activity (3’UTR) for SEQ ID NO:14, yet the claims are broadly drawn to a multitude of sequences and possible functional activities.
The Federal Circuit has 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. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of 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.
See MPEP Section 2163, 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.
Also, see Vas-Cath Inc. v. Mahurkar 1991 (CAFC) 19 USPQ2d 1111, 1115, which teaches that the purpose of written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from ostensible objects, that the patentee is required to distinguish his invention in his specification.
Therefore, given the lack of written description in the specification with regard to the structural and physical characteristics of the claimed compositions, one skilled in the art would not have been in possession of the genus claimed at the time this application was filed.
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.
Claims 1-17 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.
Claims 1-3 and 9, and claims 4-8 and 10-17 dependent thereon, are indefinite in the recitation of “any of SEQ ID NOs: 1-19 and SEQ ID NO: 26”, since it is unclear if this requires both one sequence chosen from SEQ ID NOs: 1-19 in addition to SEQ ID NO: 26, or if it is intended to be limited to only one of SEQ ID NO: 1-19 and 26. And if the claims are intended to require two sequences, then the claims are further indefinite with regard to what the relationship would be between the two sequences in the construct. For example, would these sequences be adjacent to one another, or separated within the construct. Therefore, the metes and bounds of the claimed invention cannot be determined.
Claims 1-3 and 9, and claims 4-8 and 10-17 dependent thereon, are further indefinite in the recitation of “fragment” with regard to any of the SEQ ID NOs, given that the specification indicates that in specific embodiments, a fragment may comprise “at least about 50, at least about 75, at least about 95, at least about 100, at least about 125, at least about 150, at least about 175, at least about 200, at least about 225, at least about 250, at least about 275, at least about 300, at least about 500, at least about 600, at least about 700, at least about 750, at least about 800, at least about 900, or at least about 1000 contiguous nucleotides, or longer, of a DNA molecule”. It remains unclear what “at least about” would constitute with regard to these nucleotide fragments, and while the claims are read in light of the specification, limitations set forth in the specification are not read into the claims. Therefore, the metes and bounds of the claims cannot be determined.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-5, 7-14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boukharov et al. U.S. Patent Application Publication No. 2007/0271630, published Nov. 22, 2007.
Claim 1 as it reads on the elected species is drawn to a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of: a) a sequence with at least 85 percent sequence identity to SEQ ID NO:14; b) a sequence comprising SEQ ID NO:14; and c) a fragment of SEQ ID NO:14 wherein the fragment has gene-regulatory activity; wherein said DNA sequence is operably linked to a heterologous transcribable DNA molecule.
Claim 4 is drawn to the recombinant DNA molecule of claim 1, wherein the DNA sequence comprises gene regulatory activity.
Claim 5 is drawn to the recombinant DNA molecule of claim 1, wherein the heterologous transcribable DNA molecule comprises a gene of agronomic interest.
Claim 7 is drawn to the recombinant DNA molecule of claim 5, wherein the gene of agronomic interest confers pest resistance in plants.
Claim 8 is drawn to the recombinant DNA molecule of claim 1, wherein the heterologous transcribable DNA molecule encodes a dsRNA, an miRNA, or a siRNA.
Claim 9 is drawn to a transgenic plant cell comprising a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of: a) a sequence with at least 85 percent sequence identity to SEQ ID NO:14; b) a sequence comprising SEQ ID NO:14; and c) a fragment of SEQ ID NO:14 wherein the fragment has gene-regulatory activity, wherein said DNA sequence is operably linked to a heterologous transcribable DNA molecule.
Claim 10 is drawn to the transgenic plant cell of claim 9, wherein said transgenic plant cell is a monocotyledonous plant cell.
Claim 11 is drawn to the transgenic plant cell of claim 9, wherein said transgenic plant cell is a dicotyledonous plant cell.
Claim 12 is drawn to a transgenic plant, or part thereof, comprising the recombinant DNA molecule of claim 1.
Claim 13 is drawn to a progeny plant of the transgenic plant of claim 12, or a part thereof, wherein the progeny plant or part thereof comprises said recombinant DNA molecule.
Claim 14 is drawn to a transgenic seed, wherein the seed comprises the recombinant DNA molecule of claim 1.
Claim 17 is drawn to a method of expressing a transcribable DNA molecule comprising obtaining a transgenic plant according to claim 12 and cultivating the plant, wherein the transcribable DNA is expressed.
Boukharov et al. teach a recombinant DNA molecule comprising a DNA sequence that is a fragment of SEQ ID NO:14 wherein the fragment has gene-regulatory (promoter) activity (paragraph [0020]) – see sequence alignment below between SEQ ID NO: 14 and SEQ ID NO: SEQ ID NO: 119,144 of Boukharov et al. Boukharov et al. teach operable linkage of their promoter DNA sequences to heterologous transcribable DNA molecules that comprise a gene of agronomic interest that confers pest resistance in plants and that encode a dsRNA (paragraph [0010]).Boukharov et al. teach the transformation of plant cells with their recombinant DNA molecules, including monocotyledonous and dicotyledonous plant cells, and the generation of transgenic plants therefrom, and the production of progeny including seed (paragraphs [0015]-[0016]).
Boukharov et al. do not specifically exemplify any particular recombinant DNA constructs, or any particular transgenic plant cells or plants that comprise such constructs.
Given the teachings of Boukharov et al. that a recombinant DNA molecule comprising a DNA sequence that is a fragment of SEQ ID NO:14 that has gene-regulatory (promoter) activity can be operably linked to heterologous transcribable DNA molecules that comprise a gene of agronomic interest that confers pest resistance in plants and that encode a dsRNA and subsequently used to transform plant cells that can be used to generate transgenic plants, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to make a specific recombinant DNA construct comprising a DNA sequence that is a fragment of SEQ ID NO:14 that has gene-regulatory (promoter) activity and that is operably linked to a heterologous transcribable DNA molecule that comprises a gene of agronomic interest that confers pest resistance in plants and that encodes a dsRNA, and to use that construct to transform a particular type of plant cell and generate a particular type of transgenic plant therefrom. One skilled in the art would have been motivated to do so in order to make a transgenic plant that is pest resistant. One skilled in the art would have had a reasonable expectation of success, given that genes of agronomic interest that confer pest resistance in plants were already known and used in the art for this purpose. Thus, the claimed invention would have been prima facie obvious as a whole to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Sequence alignment between SEQ ID NO: 14 and SEQ ID NO: SEQ ID NO: 119,144 of Boukharov et al.:
RESULT 17
US-11-360-355-119144
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 119144, US/11360355
Publication No. US20070271630A1
GENERAL INFORMATION
APPLICANT: Boukharov, Andrey
APPLICANT: Du, Zijing
APPLICANT: Guo, Liang
APPLICANT: Kovalic, David
APPLICANT: Lu, Maolong
APPLICANT: McCarter, James
APPLICANT: Miller, Nancy
APPLICANT: Williams, Deryck
APPLICANT: Vaudin, Mark
APPLICANT: Wu, Wei
TITLE OF INVENTION: METHODS FOR GENETIC CONTROL OF HETERODERA INFESTATIONS
TITLE OF INVENTION: IN PLANTS AND COMPOSITIONS THEREOF
FILE REFERENCE: 38-21(53885)
CURRENT APPLICATION NUMBER: US/11/360,355
CURRENT FILING DATE: 2006-02-24
NUMBER OF SEQ ID NOS: 171306
SEQ ID NO 119144
LENGTH: 1003
TYPE: DNA
ORGANISM: Heterodera glycines
FEATURE:
OTHER INFORMATION: Promoter: Source sequence=SeqID_197; Location=1601..2603; Strand=-;
Gene=SeqID_77175
Query Match 5.2%; Score 21; Length 1003;
Best Local Similarity 100.0%;
Matches 21; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 319 AAATAAATTAATAAATATTTT 339
|||||||||||||||||||||
Db 926 AAATAAATTAATAAATATTTT 946
Remarks
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662
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