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 .
Information Disclosure Statement
The listing of references on page 2 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 10, line 3. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Paragraph [0001] on page 1 of the Specification is objected to because the claim of priority is incomplete. See 37 CFR 1.78.
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.
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.
At claims 1-7, 11, 12 and 14-17 the limitation “improved b-fructofuranosidase” is a relative limitation and the claim(s) does not recite what it is relative to. Hence, the metes and bounds of the claims are unclear. Those claims dependent from these rejected claims are also indefinite because they do not define what the limitation is relative to.
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.
Applicant claims an improved b-fructofuranosidase comprising an amino acid sequence having a substitution at either or both of amino acids at position 81st and 141st position relative to instant SEQ ID NO: 1. Instant claims 4, 5, 14 and 15 recite specific amino acids that are substituted for the glycine at position 81 and the leucine at position 141. Applicant further claims a nucleic acid that encodes and a transformant that expresses said improved b-fructofuranosidase, as well as a method of using said improved b-fructofuranosidase.
Applicant describes an improved b-fructofuranosidase as having a high production proportion of trisaccharide FOS and a low production proportion of tetra- or higher-saccharide FOS by substituting an amino acid at a specific position of the amino acid sequence (SEQ ID NO: 1) of wild-type b-fructofuranosidase derived from Aspergillus fijiensis with a different amino acid (page 3, paragraph [0008] of the Specification). Applicant further describes specific amino acid substitution in instant SEQ ID NO: 1 at the glycine at position 81 and the leucine at position 141 in Tables 13, 14 and 15.
Applicant does not describe the claimed substitutions in a structural background other than instant SEQ ID NO: 1. While Applicant lists b-fructofuranosidases from other species of Aspergillus in Table 1, Applicant does not describe an improved b-fructofuranosidase having a sequence identity of 60% or more to instant SEQ ID NO: 1 having an amino acid substitution at positions relative to 81 and 14. At Table 13, Applicant demonstrates that at the glycine of position 81, substitutions with alanine, aspartic acid and glutamic acid do not produce an improved b-fructofuranosidase as defined in the instant Specification. At Table 14, Applicant demonstrates that the leucine at position 141, substitutions with glutamic acid, histidine, methionine, glutamine or valine do not produce an improved b-fructofuranosidase as defined in the instant Specification.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed. The decision in AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. 111 USPQ2d 1780 (Fed. Cir. 2014) seems to be germane to the instant case. In Abbvie, an analogy is drawn between a claimed genus and a plot of land (see pages 1789-1791). Using this analogy, the Court offered that “[I]f the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it.” Similar to the analogy drawn in Abbvie, in the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010), the court (at page 1171) offered: [M]erely drawing a fence around the outer limits of purposed genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
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 –
(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.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakamura et al (U.S. Patent 7,655,449).
Nakamura et al disclose the Aspergillus niger b-fructofuranosidase in Figure 1, and identifies the glycine at position 62 and leucine at position 122 which correspond the positions 81 and 141, respectively, of instant SEQ ID NO: 1. Table 1 of the instant Specification discloses in Table 1 that the Aspergillus niger b-fructofuranosidase is 63.94% identical to instant SEQ ID NO: 1 (instant claim 2). Nakamura et al disclose that a variant of the b-fructofuranosidase can have 1 or several or 1, 2, 3 or 4 mutations (column 4, lines 45-50). Nakamura et al disclose the substitution at position 62 can include aspartic acid or glutamic acid, and the substitution at position 122 can include isoleucine at claim 3 (these substitutions are specifically cited in instant claims 4 and 5). Nakamura et al disclose an isolated polynucleotide encoding said variant b-fructofuranosidases, a vector comprising said polynucleotide, a transformant comprising said vector and a method for producing a fructooligosaccharide using the variant b-fructofuranosidase or the transformant at claims 13-16 (see instant claims 7-14). Nakamura et al disclose that industrial production of crystal 1-kestose involves using sucrose as a substrate for b-fructofuranosidase which is purified by chromatographic separation and then crystalized at column 1, lines 48-61 (see instant claims 11-13). Finally, Nakamura et al discloses that substitutions can include tryptophan (W) and/or tyrosine (Y) at column 5, lines 17-47, while Nakamura et al do not structurally reduce to practice the invention of instant claims 16 and 17 they do appear to have conceptually reduced to practice the invention of said claims. Hence, Nakamura et al had previously disclosed the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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/David H Kruse/
Primary Examiner, Art Unit 1663