11 in 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 Status
Claims 1-17 and 19-25 are pending.
Claim 18 is cancelled.
Claims 1-17 and 19-25 have been examined.
Priority
This application is a 371 of PCT/EP2021/087804 filed on 12/29/2021 and claimed foreign priority of EP 20383169.8 filed on 12/29/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/27/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 1-17 and 19-25 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.
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The specification neither provides a representative number of staple peptide sequence comprising a linker to connect any two alpha carbon-containing amino acids at a distance of 3 or 6 amino acids away from each other within the instant SEQ IDNO: 1. Furthermore, the disclosure fails to establish a correlation between any position “i” amino acid within the instant SEQ ID NO: 1 linking to the other alpha carbon-containing amino at a distance of 3 or 6 amino acids away from the unspecified “i” amino acid to support the entire genus of the stapled peptide as claimed. The alpha amino acid positions for macrocycle formation are marked with “#” in the Table shown above. The disclosed SEQ ID Nos: 2-21 above show positions L1-A4, V6, L9, I11, Y13, V16, and K18 not for staple conjugation; thus, the specification is insufficient to support the entire genus of a staple peptide with the alpha carbon at any possible amino acid positions including the N-terminal amino acid L1 and C-terminal amino acid of K18 of the instant SEQ ID NO: 1.
Thus, claim 1 is rejected for lack of sufficient written description and claims 2-17 and 19-25 are rejected as either directly or indirectly depending on claim 1.
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 1-17 and 19-25 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.
Claim 1 is unclear with respect to the position of the amino acid comprising an alpha carbon atom at position “i”. The metes and bounds are unclear because applicant utilizes a variable “i” to define the other variables of “i+4” and “i+7” in the instant SEQ ID NO: 1. In one claim interpretation when ”i” is 1 (Leu1) and the other an alpha carbon atom is at Ser5 or Arg8. In another claim interpretation when ”i” is Lys3 and the other an alpha carbon atom is at Met7 or Thr10. MPEP 2173.02 (I) states “During examination, after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear, the claim is indefinite and should be rejected. Zletz, 893 F.2d at 322, 13 USPQ2d at 1322. For example, if the language of a claim, given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpretation, then a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate.”
Claims 2-17 and 19-25 are rejected as either directly or indirectly depending on claim 1.
Examiner’s note:
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The closest prior art reference of WO 2006/038208 A2 cited in IDS disclosed a linear peptide sequence of SEQ ID NO: 1706 as follows, but there is no reason to select this particular peptide sequences from more than 4,000 disclosed peptide sequences in WO 2006/038208 A2 for further modification of SEQ ID NO: 1706 with a linker structure to make the claimed cyclic peptide.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
06-January-2026
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654