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 .
DETAILED ACTION
Status of the Claims
Claims 1-16 are pending in this application.
Claims 1-16 are presently under consideration.
Claim Objections
Claim 16 is objected to because of the following informalities: Claim 16 should be amended to recite “……to 10 mM and 40 mM to 15 mM”. Appropriate correction is required.
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 10-13 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 an isolated peptide or a salt thereof, such as a pharmaceutically acceptable salt thereof, said peptide: (a) comprising an amino acid sequence as set forth in SEQ ID NO: 1 or SEQ ID NO: 2 or an amino acid sequence having at least 85% or at least 90%, sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2; or (b) consisting of an amino acid sequence as set forth in SEQ ID NO: 1 or SEQ ID NO:2 or an amino acid sequence having at least 75%, such as at least 80%, at least 85%, or at least 90%, sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2, wherein the peptide has an antimicrobial, antiparasitic and/or anti-inflammatory activity.
When referring to the peptide, the specification does not provide any structural attributes.
Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).”
Here, the specification fails to describe what part of the sequence correlates with the required activity (i.e. having an antimicrobial, antiparasitic and/or anti-inflammatory activity).
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
Based on the teachings of the specification, the peptide can be any peptide that: (a) comprises an amino acid sequence as set forth in SEQ ID NO: 1 or SEQ ID NO: 2 or an amino acid sequence having at least 85% or at least 90%, sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2; or (b) consists of an amino acid sequence as set forth in SEQ ID NO: 1 or SEQ ID NO:2 or an amino acid sequence having at least 75%, such as at least 80%, at least 85%, or at least 90%, sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2.
However, the specification fails to provide a representative number of examples for the claimed peptide.
The specification teaches only 4 peptides (i.e. SEQ ID NOs: 1-4) encompassed by the instant claims.
SEQ ID NOs: 1-4 are 16 amino acids long, thus, even considering only naturally occurring amino acids, one would end up with:
1) 4,800 (16x15x20) possible peptides comprising an amino acid sequence having at least 85% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2; and
2) 873,600 (16x15x14x13x20) possible peptides consisting of an amino acid sequence having at least 75% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2.
If one had to consider the thousands non-natural amino acids, one would end up with exponentially more peptides.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “at least one amino acid residue is a D amino acid”, and the claim also recites “preferably all amino acid residues being D amino acids” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Same rationale applies to claim 4.
Regarding claims 1, 5 and 13, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2-16, which directly or indirectly depend from claim 1, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as these claims incorporate by dependency the indefiniteness of claim 1.
Allowable Subject Matter
Peptides comprising any one of SEQ ID NOs: 1-4 are free of the prior art.
The closest prior art (Bengtsson et al. (WO 2019/162301)) teaches peptides similar to instant SEQ ID NOs: 1-4. However, Bengtsson et al. do not teach nor suggest peptides having the required sequence identity to SEQ ID NOs: 1-4.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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