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 .
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 1-21 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 require a genus of proteases that have at least 90%, 95%, 96%, 97%, 98% or 99% sequence identity to the polypeptide of SEQ ID NO: 1, wherein said proteases comprise one or more substitutions at positions corresponding to positions of the polypeptide of SEQ ID NO: 1 selected from positions 101, 102, 103, 106, 127 and 131, and wherein said proteases have enhanced polyester degrading activity compared to that of the polypeptide of SEQ ID NO: 1. In University of California V. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that "A written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials". As
indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. There is a significant amount of structural variability with respect to the members of the genus of proteins required by the claims. While the specification in the instant application discloses the structure of
a limited number of species of the genus of proteases recited, it provides no clue as to the structural elements required in any protease, nor does it teach which structural elements of the protein of SEQ ID NO: 1 disclosed, are required in any protease having enhanced polyester degrading activity as recited in the claims. No disclosure of a structure/function correlation has been provided which would allow one of
skill in the art to recognize which variants of the polypeptide of SEQ ID NO: 1 have protease activity and enhanced polyester degrading activity.
The claims encompass a large genus of proteins which are substantially unrelated in structure. A polypeptide having 90-99% sequence identity with the polypeptide of SEQ ID NO: 1 allows for any combination of about 3-28 amino acid modifications within SEQ ID NO: 1. The total number of variants of a polypeptide having a specific number of amino acid substitutions can be calculated from the formula N!x19A/(N-A)!/A!, where N is the length in amino acids of the reference polypeptide and A is the number of allowed substitutions. Thus, the total number of variants having as low as 90% sequence identity to the polypeptide of SEQ ID NO: 1 that result from amino acid substitutions is essentially infinite. A sufficient written description of a genus
of polypeptides may be achieved by a recitation of a representative number of polypeptides defined by their amino acid sequence or a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. However, in the instant case, the recited structural feature, i.e., 90% sequence identity to the polypeptide of SEQ ID NO: 1, is not representative of all the
members of the genus of proteases recited since there is no information as to the structural elements within the polypeptide of SEQ ID NO: 1 that are essential for the recited activity, which are the remaining structural elements required in the recited polypeptides in addition to those recited in the claims such that the desired protease and polyester degrading activity is displayed, or a correlation between structure and function which would provide those unknown structural features. Furthermore,
while one could argue that the few species disclosed are representative of the structure of all the members of the genus, it is noted that the art teaches several examples of how even highly structurally homologous polypeptides can have different enzymatic activities. Minor structural differences may result in changes affecting function, and no
additional information correlating structure with the desired functional characteristics has been provided, one cannot reasonably conclude that the few species disclosed are representative of the structure of all the proteases with enhanced polyester degrading activity required by the claims. Due to the fact that the specification only discloses a limited number of species of the genus of proteases with enhanced polyester degrading activity required by the claims, and the lack of description of any additional species by any relevant, identifying characteristics or properties, one of skill in the art would not recognize from the disclosure that Applicant was in possession of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657