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 .
Restriction/Election
Applicant’s election without traverse of Group I, claims 21-41, in the reply filed on 06/24/25 is acknowledged.
Claims 42-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/24/25.
Applicants further elected the species SEQ ID NO: 145. Claim 26 is withdrawn as not reading on the elected species.
Claims 21-25 and 27-41 are under examination. An Office action on the merits follows.
Objections
Claim 41 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 38 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. The sequence listing does not provide a defined sequence for SEQ ID NOs: 11 and 16. As such, there is no way to clearly define what is being claimed, in accordance with the sequence listing rules of 2414.01. Applicants may overcome this rejection by submitting a new copy of the sequence listing that defines these claimed SEQ ID NOs.
Claims 22, 23 and 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. It is unclear how SEQ ID NO: 145 relates to the loops of claim 21. Although it recites tryptophan residues at a specific position of 145, the claims do not clear state that they encompass SEQ ID NO: 145, or that SEQ ID NO: 145 is aligned with the embodiments of claim 21, as there are multiple Tn3 scaffolds, which may vary in sequences between the identified binding regions on the loop.
Claim Rejections 35 USC 103(A)
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 21 and 24-40 is/are rejected under 35 U.S.C. 103(A) as being anticipated by Coyle et al. (WO2013/055745) in view of Boyd et al. (J. Chromatogr. B 879 (2011) 955–960).
Coyle et al. teach Tn3 peptides having the following sequence, which corresponds to SEQ ID NO: 145 and the corresponding monomer subunits, having SEQ ID NO: 4, SEQ ID NO: 86, SEQ ID NO: 6, SEQ ID NO: 96. SEQ ID NO: 8 and SEQ ID NO: 139 [00387].
This reference teaches the structure of SEQ ID NO: 145: SQIEVKDVTDTTALITWSDDFGEYVWCELTYGIKDVPGDRTTIDLWYHHAHYSIGNLKPDTEYEVSLICRSGDMSSNPAKETFTT|GGGGGGGGGGGGGGG|RLDAPSQIEVKDVTDTTALITWSDDFGEYVWCELTYGIKDVPGDRTTIDLWYHHAHYSIGNLKPDTEYEVSLICRSGDMSNPAKETFTT|GGGGGGGGGG|DAHKSEVAHRFKDLGEENFKALVLIAFAQYLQQSPFEDHVKLVNEVTEFAKTCVADESAENCDKSLHTLFGDKLCTVATLRETYGEMADCCAKQEPERNECFLQHKDDNPNLPRLVRPEVDVMCTAFHDNEETFLKKYLYEIARRHPYFYAPELLFFAKRYKAAFTECCQAADKAACLLPKLDELRDEGKASSAKQRLKCASLQKFGERAFKAWAVARLSQRFPKAEFAEVSKLVTDLTKVHTECCHGDLLECADDRADLAKYICENQDSISSKLKECCEKPLLEKSHCIAEVENDEMPADLPSLAADFVESKDVCKNYAEAKDVFLGMFLYEYARRHPDYSWLLLRLAKTYETTLEKCCAAADPHECYAKVFDEFKPLVEEPQNLIKQNCELFEQLGEYKFQNALLVRYTKKVPQVSTPTLVEVSRNLGKVGSKCCKHPEAKRMPCAEDYLSWLNQLCVLHEKTPVSDRVTKCCTESLVNRRPCFSALEVDETYVPKEFNAETFTFHADICTLSEKERQIKKQTALVELVKHKPKATKEQLKAVMDDFAAFVEKCCKADDKETCFAEEGKKLVAASQ [0387].
Coyle also teaches a method of purification that comprises capturing the Tn3-HSA fusions from the culture supernatant by affinity chromatography using HSA affinity matrixes, (e.g., HiTrap Blue HP), washing and then eluting with an Octanoic Acid containing buffer [0459]. This reference teaches that the eluate was then loaded onto the Q-HP column after 3 -fold dilution in phosphate buffer [0460].
The difference between the prior art and the instant claims is that the prior art does not teach that a DE tryptophan is unoxidized.
Although the reference is silent as to the oxidation of residues, the claims are drawn to a composition, and not a method of making the protein. As such, the naturally occurring protein is unoxidized, and the art provides ample motivation to keep oxidation minimal, as it is art recognized that oxidation is a common occurrence throughout the purification process.
Boyd teaches that susceptibility of tryptophan (Trp) in a complementarity-determining region (CDR) to oxidation is a significant issue for large protein chain therapeutics due to the clinical efficacy and stability concerns, and they teach a method of reducing Trp oxidation with hydrophobic interaction chromatography (HIC) to separate an oxidized Trp containing population of an IgG1, and found that the best purification method was achieved using dual Dionex ProPac HIC-10 columns and removing the oxidized Trp population (abstract).
As such, it would have been obvious to one of ordinary skill in the art at the time of the invention to have taken the method of Coyle and used the oxidation reduction strategy of Boyd to reduce Trp oxidation. One would be motivated to do so because Boyd teaches that Trp residues are subject to oxidation, which decreases stability and bioavailability. As such, there is a reasonable expectation of success that one of the tryptophan residues of the scaffold will be unoxidized when using an oxidation reducing method of purification, as discussed in Boyd.
This meets the limitations of claims 21, 39, and 40, as the claims are drawn to the same SEQ ID NO: 145 as that of Coyle, any oxidated Trp residue may be separated out by the method of Boyd, as it is known in the art that reducing oxidated Trp improves stability and bioavailability. Claims 24, and 27-30 are rendered obvious because Coyle teaches the Tn3-HAS peptide compositions with the same linkers. Claims 31-37 are met because Coyle teaches the same structural features of the peptide with HSA with CDL40 specific monomer subunits attached to the HSA heterologous moiety. Claim 38 is not clear because the peptides are not defined in the sequence listing. However, it depends from claim 21 and appears to have the same structure as is disclosed by Coyle for portions of SEQ ID NO: 145. As such, claim 38 is rendered obvious for the same reasons.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
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