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 .
Specification
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 Objections
Claims 1, 9, 15, 36, 44, and 52 are objected to because of the following informalities: these claims provide for a percentage limitation, followed by an example: “at least 70%, such as 100%.” Since the ordinary artisan is wholly aware that “at least 70%” includes all percentages from 70% to 100%, there is no reason to provide “such as 100%.” Appropriate correction is required.
Claims 16, 17, 19, 24, and 25 are objected to because of the following informalities: all of these claims are drawn to limitations regarding nucleic acids that code for the amino acid sequences of claim 1. Since the instant application appears to include these nucleic acid sequences in the form of SEQ ID’s, it seems preferable that these should be claimed. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: bacterial species should be italicized; also, the first instance of a bacterium should be provided in its entirety (e.g. Escherichia coli). Appropriate correction is required.
Claim 36 is objected to because of the following informalities: the genera Fusarium and Septoria should be italicized. Appropriate correction is required.
Claim Interpretation
Many of the claims contain the limitation “optionally.” Although the limitations that follow are generally considered, if a limitation is considered “optional” it will not be considered mandatory. If it is considered optional, by the inventors, it is not a necessary part of the invention and, seemingly, cannot (and does not) provide for any patentable weight.
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, 2, 8, 9, 15-17, 19, 20, 24-26, 28, 29, 36, 42, 44 and 52 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 are drawn to a chitinolytic enzyme that possesses at least 70% homology to SEQ ID Nos 1-5, some of the dependent claims narrow the claimed percentage, or provide for complimentary nucleic acid sequences. The specification provides for a clear written description of SEQ ID Nos 1-5, in which there is a reasonable demonstration that these sequences possess chitinolytic activity. However, the limitations provide for an enzyme with chitinolytic activity that has homology to the sequences that are as low as 70%. Looking at SEQ ID No 1, there are 815 amino acids, wherein 70% homology means that there can be about 245 amino acid additions, subtractions and/or modifications with any of the other natural and unnatural amino acids; this variability, in only one of the five claimed sequences, accounts for more variations in the sequence than there are atoms in the universe. The shortest of the three sequences, SEQ ID No 2, provides for 515 amino acids, which accounts for 155 possible amino acids subtractions, additions, or modifications, which also [alone] provides for more possible sequences than there are atoms in the universe. Furthermore, there is no guidance in the claims or specification as to what is essential for the enzyme to properly operate.
As discussed above, it is clear that SEQ ID Nos 1-5 behave as chitinolytic enzymes, and as such, provide for a clear written description in the instant specification, clearly showing that the Applicant was in possession of these embodiments. However, when considering the most recent guidance regarding 35 USC 112(a) Written Description rejections (these examples are available on the USPTO website), there is not enough written description regarding all of the possible sequences claimed to suggest that the application was in possession of a representative number of enzymes with chitinolytic activity. According to the aforementioned guidance, the Applicant must show possession of a reasonable number of variants that possess chitinolytic activity to show possession. In the instant situation, the Applicant appears to only show possession of 5 enzymes that have chitinolytic behavior, and does not appear to show other variants, nor does the specification provide reasonable direction for the skilled artisan to make these variants without significant burden placed on the skilled artisan. Since there is no guidance in the claims or specification as to what is essential for the enzyme to properly operate, and which portions of the sequence can be considered superfluous and/or editable, there is no reasonable manner for the skilled artisan to generate a functional chitinolytic enzyme with the direction provided in the instant specification, since there is nothing to tell the skilled artisan what is essential for the enzyme to function as a chitinolytic enzyme.
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 2, 8, 9, 26, 29, 35, 36, 42 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.
Regarding claims 2 and 26, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
With respect to claim 8, the claim provides for two transitional phrases (comprise and consist). See MPEP 2111.03. While transitional phrases are not inherently unclear, by naming an open and closed transitional phrase, it is unclear what the Applicant considers to be essential to the invention. If the claim is telling the artisan that the interpretation can be either narrow or broad, the limitation does not provide for anything, and it is unclear how to interpret this in the context of the claimed enzyme. In order to reasonably examine the claim on its merits, it will be assumed that the broader “comprising” should be used.
With respect to claim 9, it is unclear how to interpret the transitional phrase “essentially consisting of.” While the transitional phrase is not necessarily unclear (see MPEP 2111.03), the manner in which it is being used provides for a degree of ambiguity. The transitional phrase is directed towards sequences possessing at least 70% homology to a sequence. This transitional phrase provides for ambiguity, because it is unclear what the Applicant believes “materially affects the basic and novel characteristics” of the sequence. See MPEP 2111.03(III). Since there is nothing in the instant specification to suggest what portions of the sequence are important, and what portions can be variable, there is no way for the artisan to know what modification would or would not “materially affect the basic and novel characteristics” of the sequence.
With respect to claim 29, section b) of the claim provides for all three transitional phrases applied equally to the claim limitation, this includes providing “essentially” in parenthesis. First, if the Applicant provides all three transitional phrases directed at the same limitation, it means that the broadest phrase is the only one that can reasonably be considered. Second, if the Applicant provides “essentially” in parenthesis, it is not considered at all.
With respect to claims 35, 36 and 42, these claims provide for a “use” without providing any method steps. A “use” without method steps is inherently unclear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15 appears to provide for an enzyme that is no different than the enzyme provided in the parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 9, 15, 16, 28, 29 and 52 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a chitinolytic enzyme. This judicial exception is not integrated into a practical application because the claims provide for a naturally occurring enzyme, and the naturally occurring nucleic acid sequence that codes for it. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are drawn to the product of nature, per se, without significantly more.
The claims are either drawn to a chitinolytic enzyme (claims 1, 9, 28, 29, and 52), or the nucleic acid sequence that codes for the enzyme (claims 15 and 16). Based upon the instant specification and the sequence searches for SEQ ID Nos 1-5, it appears as though the enzymes can be found in the bacterial species Photobacterium orarium. There is nothing in the instant specification to suggest that sequences 1-5 have been modified or edited in any manner. Since the specification unambiguously indicates that these enzymes can be found naturally in the P. orarium bacterium, the claimed enzymes and their complementary nucleic acid sequences must be considered products of nature. See MPEP 2106.04(b). Similarly, the claimed nucleic acid sequences would necessarily parallel explicitly described case law. See Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013).
When further analyzing compositions that could be interpreted as nature-based products the claims must be analyzed under the “markedly different characteristic analysis.” See MPEP 2106.04(c). Specifically, since the claimed chitinolytic enzymes behave the same in vitro as they would in vivo, there is no evidence that the claimed enzymes are anything more than products of nature, as defined by the MPEP. As such, these claims are ineligible under 35 USC 101.
Claims 35, 36 and 42 are rejected under 35 U.S.C. 101 because the claimed invention lacks patentable utility. The claims provide for a “use,” but do not provide for any steps of using the product. For all intents and purposes, the claims provide for a method without any methods steps. A method with no method steps lacks utility and is not patent eligible.
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.
Claims 35 and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cletus, et al (Biotechnology Letters, 35, 1719-1732, 2013). Cletus teaches methods of inserting chitinolytic enzymes into plants as a means of enhancing disease resistance. See page 1719, “Abstract” section.
With respect to claim 35, Cletus describes using the enzyme as a means of enhancing plant disease resistance.
With respect to claim 43, Cletus provides transgenic plants that produce chitinolytic enzymes. This production of enzymes accomplishes the claimed task of plant protection. See page 1719 and 1720, entire.
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.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651