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 1-10 are pending in this application.
Claims 1-10 are presently under consideration.
Claim Objections
Claims 1-10 are objected to because of the following informalities: Claim 1 should be amended to recite “A polypeptide selected from the group consisting of or a pharmaceutically acceptable salt thereof, wherein……. Claim 8 should be amended to recite “A polypeptide selected from the group consisting of , or a pharmaceutically acceptable salt thereof”. Claims 2-7 and 9-10 depend upon objected claims. Thus, they are also objected. Appropriate correction is required.
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.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims recite a use without any active, positive steps delimiting how this use is actually practiced (see MPEP 2173.05(q)).
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.
Claim 10 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 10 recites a use without any active, positive steps delimiting how this use is actually practiced (see MPEP 2173.05(q)).
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 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alsina-Fernandez et al. (WO 2019/125938).
Claim 9 is directed to a pharmaceutical composition comprising a therapeutically effective amount of the polypeptide as an active ingredient or the pharmaceutically acceptable salt thereof according to any one of claims 1 to 8, or a pharmaceutically acceptable carrier.
Therefore, the claim encompasses the following:
1) a pharmaceutical composition comprising the polypeptide any one of claims 1 to 8; OR
2) a pharmaceutical composition comprising a pharmaceutically acceptable salt of the polypeptide any one of claims 1 to 8; OR
3) a pharmaceutically acceptable carrier.
Alsina-Fernandez et al. teach a pharmaceutical composition comprising a pharmaceutically acceptable carrier (claim 26).
To overcome this rejection, claim 9 should be amended as follows:
A pharmaceutical composition comprising a therapeutically effective amount of the polypeptide as an active ingredient or the pharmaceutically acceptable salt thereof according to any one of claims 1 to 8, and a pharmaceutically acceptable carrier.
Examiner’s note
The closest prior art (Alsina-Fernandez et al.) teach incretin polypeptides of similar structure to the instantly claimed polypeptides.
However, Alsina-Fernandez et al. do not teach nor suggest cyclization via the side chains of lysine residues.
Therefore, the claimed polypeptides are both novel and unobvious.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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