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 in 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The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper.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).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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.
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, 13, 34, 66, 69-71, 74-80 and 83 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. Claim 1 provides for a polypeptide having esterase activity, wherein the polypeptide has at least 80% homology to SEQ ID No 1. Based upon the most recent guidance, regarding 35 USC 112(a) Written Description rejections and interpretation, since the claim explicitly lists a functional limitation, with respect to a variable sequence, the specification must be analyzed to determine if the Applicant provides for a reasonable number of embodiments that fulfill the 80% homology claim that also include esterase activity.
First, it must be noted that the instant specification appears to provide reasonable support that all of the sequences listed with a SEQ ID have esterase activity. Additionally, claims 11, 28, 30, and 32 all provide for smaller possible mutations that would not require an unreasonable amount of testing for the skilled artisan; as such, these claims, and claim 64 are not rejected under 35 USC 112(a). However, when considering the base claim, the number of possible mutations accounts for approximately 51 possible substitutions, mutations, or deletions, that would provide more possible sequences than there are atoms in the universe. As such, the base claim provides such an immense number of possibilities that the skilled artisan would be under a tremendous burden to test all of these possible sequences to determine which sequences possess esterase activity. If the “esterase activity” limitation is removed from the independent claim, the rejection of claims 13, 34, 66, and 69 would likely be withdrawn. Since claims 70, 71, 74-79, and 83 are drawn to sequences that must have esterase activity, they would provide for the written description issues, even if the limitation was removed from claim 1; therefore, these claims must have limitations drawn to specific sequences, or specific mutations, wherein there is reasonable evidence of esterase activity, for the rejection to be withdrawn.
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.
Claim 69 is 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.
Claim 69 is indefinite because it is dependent on a canceled claim. For the sake of examining the claim on its merit, it will be assumed to be dependent on claim 66, since this is the only claim that describes polynucleotides.
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.
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 80 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ribitsch, et al (Polymers, 4, 617-628, 2012). Ribitsch teaches the hydrolytic products of polyethylene terephthalate. See page 617, “Abstract” section. It should be noted that, even if we exclude Ribitsch, the claimed compounds were all known long before the effective priority date of the instant invention. Any discussion of these monomers, even if they were not the products of the claimed reaction, would anticipate the instant claim, because these monomers are known and cannot be patented by the instant claim. Notably, terephthalic acid was first isolated/described in 1846, and ethylene glycol was first synthesized in 1856.
Allowable Subject Matter
Claims 4, 11, 28, 30, 32 and 64 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651