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 .
Status of the Claims
The preliminary amendment filed 01/02/2024 is acknowledged. Claim 3 is amended. No restriction is being imposed in this case. Claims 1-3 are under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 1-3 are objected to because of the following informalities.
The claims should be amended to recite customary claim language. For instance, claim 1 should be amended to recite: “A circular polypeptide consisting of the set forth in A pharmaceutical composition” and claim 3 should be amended to recite “The polypeptide”. The absence of articles at the beginning of the claims is grammatically awkward.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 2 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 2 recites a “composition comprising a polypeptide according to claim 1”, which suggests that there could be more than one polypeptide. Claim 1, from which claim 2 depends, however, requires that the circular polypeptide consists of the sequence SEQ ID NO: 1. The phrase “consists of” in claim 1 sets forth a single circular polypeptide that excludes any other elements (see MPEP 2111.03(II)), thus the use of the indefinite article in claim 2, suggesting there may be other polypeptides according to claim 1, is confusing. This issue could be overcome by amending the phrase in claim 2 to recite something like: “…composition comprising the polypeptide of claim 1”.
Closest Prior Art
Gräber et al. (WO2012/022486) disclose an AHSG (fetuin A) polypeptide comprising the fetuin calcium binding domain, referred to therein as the D1 domain and cite to Heiss et al. (J Biol Chem 2003; 278: 13333-13341—see p. 10, lines 20-22 of Gräber and colleagues). Heiss et al. disclose the D1 domain as comprising residues 5-63 of human AHSG:
PGLIYRQPNCDDPETEEAALVAIDYINQNLP---WGY-KHTLNQIDEVKVWPQQPSGELF, which shares 86.2% local similarity with instant SEQ ID NO: 1:
Query Match 40.9%; Score 128; DB 1; Length 30;
Best Local Similarity 86.2%;
Matches 25; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 3 LIYRQPNCDDPETEEAALVAIDYINQNLP 31
|||||||||||||||||||||||| : |
Db 1 LIYRQPNCDDPETEEAALVAIDYIAPHGP 29
Gräber et al. disclose a preferred embodiment in which “the fetuin calcium binding domain comprises or consists of amino acids 5 to 115 of the human mature fetuin-A polypeptide (the protein of SEQ ID NO: 1 where amino acids 1 to 18 have been cleaved off” (see claims 1-3; p. 9, SEQ ID NO: 1; p. 10, lines 20-22), which would result in a polypeptide comprising:
APHGPGLIYRQPNCDDPETEEAALVAIDYINQNLPWGYKHTLNQIDEVKVWPQQPSGELFEIEIDTLETTCHVLDPTPVARCSVRQLKEHAVEGDCDFQLLKLDGKFSVVYAKCDS,
which also shares 86.2 local similarity with instant SEQ ID NO: 1:
Query Match 20.1%; Score 128; DB 1; Length 30;
Best Local Similarity 86.2%;
Matches 25; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 7 LIYRQPNCDDPETEEAALVAIDYINQNLP 35
|||||||||||||||||||||||| : |
Db 1 LIYRQPNCDDPETEEAALVAIDYIAPHGP 29
There is no suggestion in the prior art to mutate the sequence such that they would consist of instant SEQ ID NO: 1. The MPEP 2111.03(II) instructs that the transitional phrase “consists of” excludes any element, step, or ingredient not specified in the claim. The prior art of Demetriou et al. (Journal of Biological Chemistry, 1996; 271: 22: 12755-12761—on IDS filed 01/02/2024) disclose cyclic peptides derived from fetuin, however, they are structurally unrelated to instant SEQ ID NO: 1. In summary, the prior art does not teach or suggest the claimed cyclic AHSG polypeptide, let alone the D-amino acid version thereof.
The post-filing date art of van den Akker et al. (Osteoarthritis and Cartilage 31 (2023) 727-740—on IDS filed 01/02/2024) describes the development of the cyclic-inverso peptide of the instant invention, which as with the Examples in the instant specification, describe the ability of the peptide to “clear inhibition of calcium phosphate precipitation in the nM-pM range that far exceeded the biological activity of the linear peptide variant or bovine” (see abstract; p. 734, Figure 5B; p. 735, left column, 1st full paragraph).
Conclusion
Claim 2 is rejected; claims 1-3 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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