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 .
Claims 1-14 are pending and examined herein on the merits.
Claim Interpretation
The Claims are drawn to and recite both “synthetic” promoters and “artificial” DNA. The specification does not define either term and it is unclear if the term synthetic and/or artificial is referring to how the sequence is made, or is actually referring to a structural difference between the claimed sequences and naturally occurring sequences. Absent a definition of the term, the Examiner must interpret the broadest reasonable interpretation. It is noted that the specification does state “This synthetic promoter has a specific artificial DNA sequence, advantageously optimized for the overexpression of recombinant proteins, in particular monoclonal antibodies as indicated above, in cereal endosperm, in particular rice
Endosperm.” This statement implies that there are structural sequences that are required for said optimization, however, many of the claims as set forth below do not have any sequence or structural requirements, and therefore it is unclear what limitation the term synthetic or artificial has on the claimed sequences. Since particularly with the term “artificial” sequence the specification has numerous references to being artificially synthesized in the lab, it is noted that it appears to be talking about the process of making the sequence, rather than any sequence or structural requirement. To the extent that the invention is drawn to specific arrangements of specific fragments for achieving this optimization, it appears these limitations are provided independently from the term synthetic and artificial. Accordingly, for the purposes of examination, the terms artificial and synthetic will be considered to refer to how the DNA was generated and it is understood that naturally occurring sequences could be generated in the lab synthetically.
Additionally, the claims recite “fragments” “coming from three specific natural endosperm promoters, respectively GluB4, Prol16 and Glb”, however it is noted that the sequence lengths listed in claim 1 are referencing the spacing and linker sequences and not these promoter based fragments. There is no language in the specification that limits the minimum size of any such fragment, although specific embodiments are listed after the phrase “in accordance with some embodiments” implying that other embodiments are within the scope of the invention and therefore claims. Accordingly, a fragment coming from one of those promoters could be as small as 2 bp which would read on numerous sequences.
Claim Rejections - 35 USC § 112
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.
Claims 1-14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the term “for use in the stable expression of infliximab or its derivatives in rice endosperm”. Because the specification does not set forth any specific limitations or structural requirements that are specific to Infliximab or its derivatives it is unclear whether this phrase was intended to limit the structure or not. Accordingly it is not clear what the metes and the bounds of the claims are regarding this phrase.
Claims 2-5, and 7-12 all recite DNA elements “defined by” SEQ ID Nos. It is unclear what it means to be defined by a sequence. While it is expected the DNA elements might comprise, contain or consist of said SEQ ID Nos, it is not clear what it means or imparts to be defined by the sequence. It is unclear what the defining aspects of the SEQ ID NO impart. If it is a promoter sequence, is the element defined by a promoter such that other sequences other than the listed sequence are encompassed? In this case, a careful reading of the specification appears to indicate that it is intended that this recitation would limit the sequence to the SEQ ID NO that it is defined by, however, as this is not comprising language, it is possible that this is more limiting than intended by applicants. For the purposes of examination the Examiner is interpreting the claims such that DNA elements comprise the recited SEQ ID Nos.
Claim 1 recites “in particular comprised between 100 and 125 nucleotides” after reciting “a length of at least 100 nucleotides” which is a narrow limitation following a broad limitation.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-9 and 13-14 are rejected under 35 U.S.C. 112(a) 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, at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a multitude of synthetic promoter artificial DNAs as well as an expression vector comprising said sequences and a method for the stable production of Infliximab or its derivatives comprising transforming plants with said vector.
In contrast, the specification describes specific Vectors with specific combinations of sequence elements, specifically the promoter comprising SEQ ID NO:8 as well as the fused promoters for the stable expression of Infliximab or its derivatives. The specification does not describe the multitudes of sequences and sequence derivatives encompassed by the claims as written for the stable expression of Infliximab or its derivatives.
The Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention “requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the 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.
Finally, the court held:
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 a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. Id.
See also MPEP section 2163, page 174 of chapter 2100 of the August 2005 version, column 1, bottom paragraph, 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.
See also Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1016 at 1021, (Fed. Cir. 1991) where it is taught that a gene (which includes a promoter) is not reduced to practice until the inventor can define it by "its physical or chemical properties" (e.g. a DNA sequence).
Given the claim breadth and lack of description as discussed above, the specification fails to provide an adequate written description of the genus of sequences as broadly claimed. Given the lack of written description of the claimed genus of sequences, any method of using them, such as transforming plant cells and plants therewith, and the resultant products including the claimed transformed plant cells and plants containing the genus of sequences, would also be inadequately described. Accordingly, one skilled in the art would not have recognized Applicant to have been in possession of the claimed invention at the time of filing. See the Written Description Requirement guidelines published in Federal Register/ Vol. 66, No. 4/ Friday January 5, 2001/ Notices: pp. 1099-1111.
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 13-14 are anticipated by Aysha et al (2018 Molecular Biotechnology 60:608-620).
The claims are broadly drawn to synthetic promoters with any DNA fragment size and sequence coming from three specific natural endosperm promoters respectively, GluB4, Prol16 and Glb, operatively linked to each other by means of two synthetic linking and spacer portions wherein the first portion is between 75 and 100 nucleotides and a second is at least 100 nucleotides and an expression vector comprising said sequences.
Aysha et al teach building synthetic promoters and testing them in expression vectors comprising DNA elements which would inherently have at least 2bp combinations from the listed natural promoters wherein the elements are separated by at least 2 linker sequences wherein the sequences comprise sequences of 100bp (see figures 1-2 and 4).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 EST.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663