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 Objections
Claims 9 and 11-13 are objected to because of the following informalities: in the aforementioned claims, the noun “use” is preceded by the article “an.” While technically correct, it is more appropriate in American-English for the noun “use” to be preceded by the article “a.” Appropriate correction is required.
Claim Rejections - 35 USC § 101/112
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.
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 9 and 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specifically asserted utility or a well-established utility.
The claims are drawn to a “use” of the claimed compound without any method steps describing its “use.” A method without method steps has no specifically claimed utility, and cannot be eligible under 35 USC 101.
Claims 9 and 11-13 are also rejected under 35 U.S.C. 112(a). Specifically, because the claimed invention is not supported by either a specifically asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
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 1-16 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.
The term “strong bactericidal effect” in claim 1 is a relative term which renders the claim indefinite. The term “strong bactericidal effects” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of bactericidal effects define “strong” and where the lower limit cutoff for “strong” and the beginning of “weak” would encompass. Furthermore, it is unclear if this effect is purely based upon the polypeptide sequence, or if the strength of the effect is concentration dependent.
Claims 1-13 do not include a transitional phrase. See MPEP 2111.03. As such, it is unclear how open the scope of the claimed limitations should be. For example, if claim 1 used “comprising,” instead of “consisting of,” the composition could include other unclaimed elements; however, if the intent is “consisting of,” the antimicrobial protein must be limited to what is explicitly claimed. The claimed transitional phrase has a profound impact on how the artisan would interpret the metes and bounds of the claimed invention. For the sake of examining the claims on their merits, all claims drawn to sequences will be assumed to be “consisting of,” whereas “preparations” and “uses” will be assumed to be “comprising.”
While it is noted that claim 1 does use the word “comprising,” this is in reference one specific limitation, and not to the claim as a whole.
Claim 1 provides for the limitation “comprising a sequence similar to.” This limitation is indefinite because it is unclear what degree of similarity is considered “similar.” For example, it is unclear if 80% homology is close enough for “similar,” or if homology must be closer to 95% for the claimed sequence to be “similar” and provide for the claimed domain that is functional and enabled. Furthermore, it is unclear if the claimed “similarity” means that only certain amino acids can be mutated, and how similar the amino acid mutant counterparts must be, compared to the claimed amino acid. For example, can leucine be mutated into any other amino acid, or must the mutant possess similar aliphatic functional groups.
Claims 3 and 5 explicitly define the “similar” sequences claimed in claim 1 (SEQ ID No 3 and 5), and are clear in this respect; however, as discussed above, these claims do not include transitional phrases, making the metes and bounds of their scope unclear. As discussed above, it is assumed that these are narrowly drawn to the claimed sequences, and nothing more.
Claims 10, 14 and 16 are indefinite because it is unclear what an “effective amount” would comprise. Based upon claim 1, the claimed protein inherently possesses antimicrobial properties, and as such, it can be reasoned that as little as one molecule can be “effective.” Therefore, it is unclear how much would be needed in an undescribed “use,” or “preparation.”
Any claim not explicitly rejected in the 35 USC 112(b) rejections above are also rejected under 35 USC 112(b) insofar as they claim dependence on a rejected claim and do not cure the above-described indefiniteness.
Allowable Subject Matter
Following a sequences search for SEQ ID No 1-8, it appears as though the sequences, per se, are free of the prior art. However, as described in the above rejections, there are issues with claim language and interpretation that preclude the claims from being allowable.
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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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
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