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 .
Claims 25-44 are pending and examined on their merit herein.
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.
Scope of Enablement
Claims 25-26, 28-37, and 39-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for [ the recombinant DNA molecule, or the polypeptide encoded thereby, or the plant and method thereof, wherein the amino acid sequence of the polypeptide has at least 80% sequence identity to the amino acid sequence of RdpA as set forth in SEQ ID NO: 1, or at least 92% sequence identity to SEQ ID NO: 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, 58, 62, 66, 70, 74, 78, 82, 86, 90, 94, 98, 102, 106, 110, 114, 118, 122, 126, 130, 134, 138 or 142; or wherein the nucleic acid sequence is any of SEQ ID NO: 3, 4,5,7, 8, 9, 11, 12, 13, 15, 16, 17, 19, 20, 21, 23, 24, 25, 27, 28, 29, 31, 32, 33, 35, 36, 37, 39, 40, 41, 43, 44, 45, 47, 48, 49, 51, 52, 53, 55, 56, 57, 59, 60, 61, 63, 64, 65, 67, 68, 69, 71, 72, 73, 75, 76, 77, 79, 80, 81, 83, 84, 85, 87, 88, 89, 91, 92, 93, 95, 96, 97, 99, 100, 101, 103, 104, 105, 107, 108, 109, 111, 112, 113, 115, 116, 117, 119, 120, 121, 123, 124, 125, 127, 128, 129, 131, 132, 133, 135, 136, 137, 139, 140, 141 or 143-181, or their degenerate equivalent; AND wherein the polypeptide has a leucine-to-histidine mutation at position 82 of SEQ ID NO: 1], does not reasonably provide enablement for any recombinant DNA or polypeptide encoded thereby that when compared with SEQ ID NO: 1 has a leucine-to-histidine mutation at position 82 of SEQ ID NO: 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/use the invention commensurate in scope with these claims.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
In the instant case, the claims recite a broad genus of polypeptides (and the corresponding encoding polynucleotides, DNA constructs, transgenic plants, and methods) that wen compared with the amino acid sequence of RdpA as set forth in SEQ ID NO: 1, the amino acid sequence of the polypeptide has a leucine-to-histidine mutation at position 82.
It should be noted that the claims are broad in that the claims are not limiting the polypeptide to any degree of sequence similarity or identity with SEQ ID NO: 1, as long as when the polypeptide sequence is compared with SEQ ID NO: 1, the amino acid that is corresponding to the Leu of position 82 of SEQ ID NO: 1 is a His. Thus, the claims broadly encompass the polypeptides that may not have any functional structure of the RdpA protein.
In contrast to the broad scope of the claims, Applicant has provided enabling teachings regarding the L82H mutant of RdpA as set forth in SEQ ID NO: 1, or optionally with additional second, third or fourth amino acid substitutions, wherein the mutant RdpA proteins have increased enzymatic activity against herbicidal compounds “Compound A” or “Compound B”, both being pyridyloxy carboxylic acid ester derivatives.
However, Applicant has not provided any enabling guidance regarding the enzymatic activity of the broadly claimed genus of various polypeptides having any degree of sequence similarity that makes a sequence alignment possible. Applicant has not provided enabling guidance as how the Leu-to-His mutation at the corresponding position would impact the activity or function of the broad genus of polypeptides.
Thus, in view of the unpredictability associated with combinatorial substitutions in a protein, the lack of enabling guidance from either the instant disclosure or the art, and breath and diversity of the embodiments encompassed by the claimed genus, the lack of sufficient working examples, and the level of the art at the time of the invention, one of ordinary skill in the art must rely on undue trial and error experimentation to make and test the numerous polypeptides having multiple amino acid substitutions, in order to make and/or use the invention within the full scope of these Claims.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
Conclusion
Claims 25-26, 28-37, and 39-44 are rejected.
Claims 27 and 38 are objected to for being dependent on rejected base claims.
Claims 25-44 are free of the prior art because there is no prior art teaching or suggesting the claimed RdpA polypeptide as set forth in SEQ ID NO: 1 with the Leucine at position 82 substituted with a Histidine, the encoding recombinant polynucleotide, construct, and plants comprising the mutant protein.
The closest prior art, among others, is Ellis et. al. (US10023874B2, July 17, 2018) which teaches recombinant DNA molecule comprising a nucleic acid sequence encoding a polypeptide having at least 92% identity to an amino acid sequence selected from the group consisting of SEQ ID NO:1, 4, 7, 9, 11, 14, 18, 22, 25, 28, 31, 34, 37, 40, 43, and 46-52; plant, seed, plant tissue, plant part, or cell comprising a recombinant DNA, and so on. The prior art teaches SEQ ID NO: 60 which is wild-type RdpA from Sphingobium herbicidovorans and 100% identical with the instant RdpA of SEQ ID NO: 1; and SEQ ID NO:1, 4, 7, 9, 11, 14, 18, 22, 25, 28, 31, 34, 37, 40, 43, and 46-52 are various variants. Among the amino acid substitutions, Ellis teaches Leucine-to-Isoleucine substitution at position 82 (L82I or I82) (MON-HT1, SEQ ID NO:14 has the following amino acids at the indicated position: I82; F105; T112). However, Ellis does not teach or suggest the H82 mutation and its increased enzymatic activity against herbicidal compounds A and B.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663