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 Application
Claim(s) 1-6, 8-24 are pending and under examination
Claim(s) 17-24 are newly added
The following Office Action is in response to Applicant's communication dated 08/13/2026.
Rejection(s) and/or objection(s) not reiterated from previous office actions are hereby withdrawn. The following rejection(s) and/or objection(s) are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
RE: Applicant argues that Dogan does not disclose the claimed poly-repeat architecture [page 11].
In response, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
RE: Applicant argues that RCA was not an obvious method for producing the claimed tandem repeats [page 14].
In response, applicant’s argument have been fully considered but they are not persuasive. RCA functions independently of biological function encoded by the template and predictably produces tandem repeats DNA from suitable circular template. Claim 16 does not recite any specialized RCA conditions or unexpected results. Also, Amiram et al. (Nat Mater. 2011;10(2):141-148) expressly used RCA to generate repetitive gene encoding repetitive polypeptides. Hence, applying RCA to a template encoding the claimed peptide repeat would have been a known technique yielding predictable poly-repeat DNA product.
RE: Applicant argues that Dolton does not cure Dogan’s deficiency and proposed combination would not have been obvious or predictably successful [pages 12-14].
Applicant’s argument is persuasive. The previous rejection is therefore withdrawn.
New Claim Rejections - 35 USC § 112(b)-Necessitated by amendments
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(s) 14, 22, and 24 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 14 recites “the unique pMHC complex”. However, amended claim 1 no longer provide antecedent basis for a “unique pMHC complex”. Claim 1 requires multiple identical repeat sequences, each engaged in a pHMC complex. It is unclear which pMHC complex is intended by “the unique pMHC complex” and whether encoding molecule must be linked to one pMHC complex, each pMHC complex, or the collection of pMHC complexes. Hence the claim is indefinite and the metes and bounds of the claim are unascertainable.
Claim 22 recites “the pMHC complex comprises” one of several listed alleles. An allele is a nucleic acid variant, whereas a pMHC complex is a protein complex. It is unclear whether the claim requires the pMHC complex to contain the recited nucleic acid, an MHC polypeptide encoded by the recited nucleic acid, or an allele specific MHC protein. Hence the claim is indefinite and the metes and bounds of the claim are unascertainable.
Claim 24 recites “the identical repeat sequences is 15-100 bp”, indicating the claim defines the length of peptide repeats in base pairs, which is unit for nucleic acids rather than peptides. It is unclear whether the claim intends each repeat to be 15-100 amino acid in length or each corresponding nucleic acid repeat to be 15-100 base pairs long.
Subject matter free of prior arts
Instant claims 1 and 15 contain subject matter free of prior arts. The following references were considered as the closest prior arts:
Dogan et al. (Eur. J. Immunol 34.2 (2004): 598-607, disclosed in IDS) discloses a phage-displayed library of noncovalent complexes of peptide and MHC (P/MHC), wherein soluble MHC molecules associate with peptides presented by a phage, thereby resulting in the formation of multivalent P/MHC phages. Complex formation is stabilized by the interaction of the soluble partner (MHC) with two components, peptide and β2-microglobulin, both of which are covalently linked to the phage [abstract]. However, Dogan does not teach poly-repeat peptide configuration of the displayed peptide.
Dolton et al. (Clin Exp Immunol. 2014;177(1):47-63., of record) teaches dextramers (dextran-based multimers), with the latter carrying greater numbers of both pMHC and fluorochrome per molecule [abstract]. However, Dolton does not teach formation of P/MHC phages.
It is not obvious to combine Dogan and Dolton references to arrive at the claimed a poly-repeat peptide comprising multiple identical repeat sequences, each of which is engaged in a pMHC complex. Dolton’s dextramer is attached to a dextran scaffold using streptavidin-biotin interaction. On the other hand, Dogan displays discrete peptide copies on a phage coat protein for association with soluble MHC. Neither reference teaches nor suggest replacing the discrete peptide with single genetically encoded tandem repeat polypeptide, where each repeat interacts with a separate MHC molecule.
Additionally, the modification would require consideration of peptide repeat length, linker structure, backbone flexibility, accessibility of each MHC-binding sequence, steric between adjacent MHC molecules, and compatibility of the enlarged peptide-MHC complex with phage production and display. Dolton’s results would not provide a reasonable expectation that its dextran-based spatial arrangement is well transferable to Dogan’s phage system or that repeats in a continuous peptide would bind a MHC molecule without steric. Hence, Dolton and Dogan do not provide sufficient technical teaching and suggestion for one of ordinary skill in the art to arrive at the claimed invention.
Claims 2-6, 8-14 and 16-24 depend on claims 1 and 15, thus also contain subject matter free of prior arts.
Conclusion
Claims 1-6, 8-24 contain subject matters free of prior arts.
Claims 14, 22, and 24 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Khai Quynh Tien Pham whose telephone number is (571)272-6998. The examiner can normally be reached M-T, 9-4 ET.
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/KHAI QUYNH TIEN PHAM/Examiner, Art Unit 1684
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
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