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
Acknowledgement is hereby made of receipt and entry of the communication filed on Mar. 24, 2023. Claims 1-20 are pending and currently examined.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Base claims 1 and 2 recite polypeptide formulas (I)-(IV), including DsF and/or FimGt. The claims specify that “DsF designates a bacterial DsF-polypeptide required for binding to FimGt or a bacterial homolog thereof” and “FimGt designates a bacterial FimGt-polypeptide required for binding to DsF or a bacterial homolog thereof.” These two limitations are not clear. First, the two limitations appear to be defining the DsF and FimGt in the formulas circularly, i.e., DsF is described based on FimGt which is in turn described based on DsF.
The instant specification describes DsF as N-terminal extension (termed donor strand, Ds) of the FimG’s partner subunit FimF. See [0041]. The specification teaches that the term FimGt shall include the full length sequence of FimG or a bacterial homo log thereof, as well as FimG variants, in particular variants showing improved binding, such as the N-terminal deletion variant of residues 1-12 truncated, optionally with the substitution Q134E. See [0042]. It teaches that the term DsF shall include the full-length sequence of FimG or a bacterial homolog thereof, as well as FimF variants, in particular variants showing improved binding, such as the peptide SRIRIRGYVR. See [0043]. Here, the indication that the term DsF shall include the full-length sequence of FimG or a bacterial homolog thereof makes the claimed invention not clear, because DsF, as defined throughout the specification as well as the conventional understanding in the art, refers to a binding portion of the N-terminal extension (termed donor strand, Ds) of the FimF. It is not clear how it can include the full-length sequence of FimG or a bacterial homolog thereof. Therefore, the definition of the term DsF is not clear in the instant specification, which in turn, renders the claims unclear.
Claim 6 recites “the independent contiguous polypeptide sequences of formula I and II, and formula III and IV”. This limitation lacks antecedent basis since claim 1 which claim 6 depends from does not recite formulas III-IV.
Claims 9, 10 and 13, which depend from claim 1, refer to SUB or “the substrate (SUB)”. These limitations do not have antecedent basis since claim 1 does not recite a substrate (SUB).
To solve issues with claims 6, 9-10 and 13, Applicant may consider combining claims 1 and 2 into one claim by reciting the two protein complexes alternatively.
Claim 13 recites “variants of POI and/or SUB” which renders the claim indefinite. The base claims 1 and 2 do not specify what the POI and SUB are, i.e., they are generic. It is not clear what variants of a generic polypeptide can be. E.g., it is not clear if it can be absent, or if it can be a part of an FimF (for POI which is linked to the C-terminus of DsF in formula I). In both cases, the polypeptide with formula I may read on a naturally occurring product, i.e., a FimF or a part thereof. Additionally, it is not clear how a nucleic acid may comprise “variants” of proteins (POI and/or SUB refer to proteins).
Claim 15 recites “providing a library according to claim 10” and “contacting said library or ligand to said library.” However, claim 10 is not directed to a library. Therefore, these limitations do not have antecedent basis.
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.
Claims 11, 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giese et al. (Angew. Chem. Int. Ed. 2012, 51: 4474 –4478; submitted in IDS filed on Mar. 24, 2023).
These claims are directed to a nucleic acid encoding for the first or second polypeptide chain of the protein complex according to claim 1.
The first polypeptide of claim 1 is defined by formula (I): X-DsF-Y-POI.
Giese teaches the establishment of the FimGt/DsF system for use in the affinity purification of heterooligomeric protein complexes from cell extracts. Utilizing the donor strand of FimF as the affinity tag (termed DsF tag) and FimGt as the binding partner, a one-step purification of DsF-tagged E. coli tryptophan synthase, a heterotetrameric abba complex of low cellular abundance, is demonstrated. See page 4474, left column, para 2. The study also uses the DsF to tag other proteins, such as dithiol oxidase DsbA from E. coli. See page 4475, right column, last para. Giese teaches that DsF was fused to the N terminus of TrpA and DsF-tagged TrpA was produced at near endogenous levels in E. coli BW25113 DtrpA768:kan cells by using the tetA promoter (Figure S5a in the Supporting Information). See page 4476, left column, para 1.
Here, the DsF-tagged TrpA or other POI’s are encompassed by formula (I), and the expression of the DsF-tagged polypeptides in E. coli using a promoter implies existence of nucleic acids encoding them.
Regarding claim 14, the existence of multiple DsF-tagged proteins together is considered as a “library”.
Accordingly, Giese teaches each and every aspect of claims 11, 13 and 14.
Conclusion
No claims are allowed.
Claims 1-20 contain allowable subject matter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JANET ANDRES, on (571) 272-0867, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/
Primary Examiner, Art Unit 1671