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 .
Response to Amendment
The amendment filed 12/19/2025 has been entered.
Any previous rejections not reiterated herein have been withdrawn.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1, 3-8, 10, 12, 14-16, 20 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Lieber et al. (US2015/0246949A1; "Lieber-2").
Lieber-2 teaches a polypeptide comprising an Ad3 adenovirus fiber polypeptide shaft domain motif (reads on applicant's SEQ ID NO:1), which may have substitutions or deletions; a peptide sequence that induces opening of a tumor
tight junction and binds to desmoglein-2; a multimerization domain; a conjugatable moiety for conjugating compounds, e.g., for covalent attachment and isolation, including CYB and CYD peptides, and GST and MBP affinity tags; and a spacer peptide that has structural flexibility, such as a peptide that comprises repetitions of amino acid residues such as Gly-Gly-Gly-Ser, or an antibody hinge region (Abstract; SEQ ID NO: 31; 1 0006-0013, 0087, 0089, 0091-0098, 0102-0120, and 0130-0132). The polypeptide may further comprise one or more compounds conjugated thereto such as therapeutics, diagnostics, and imaging agents (1 0006-0013 and 0102-0120), since the compounds are conjugated to the polypeptide, they must be through an amino acid, since that it what polypeptides contain. Lieber-2 further teaches a composition comprising the polypeptide and a pharmaceutically acceptable carrier (1 0006-0013 and 0102-0120). Although Lieber-2 teaches all the domains of the polypeptide as claimed, Lieber-2 does not explicitly teach the specific order of domains. However, Lieber-2 also teaches that the polypeptide elements are "operatively linked", which refers to an arrangement of elements wherein the domains are configured so that they function as a unit for their intended purpose. The term does not require that the domains are immediately adjacent on the polypeptide, as spacer/linker sequences may be present between the domains, the lengths of which can be quite variable. In one non-limiting embodiment, the spacer length between any two domains of the recombinant AdB-2/3 fiber polypeptides can be between about 0 amino acids and about 20 amino acids (T 0089). Regarding, the new limitation of claim 1 (e.g., one or more compounds shows improved delivery over unconjugated compounds),
first, Lieber-2 teaches the improved delivery, see for example, para. [0018], [0244], etc. and second, same compositions must have the same properties. As stated above Lieber-2 teaches a polypeptide comprising an Ad3 adenovirus fiber polypeptide shaft domain motif (reads on applicant's SEQ ID NO:1) which is conjugated to various same compounds, e.g., chemotherapeutics, etc. Regarding new claim 36, opening tumor tight junctions is taught by Lieber-2, see at least para. [0148], [0156] and [0244]. Additionally, as stated above, since Lieber-2 teaches the same conjugates as claimed, they must have the same properties.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the arrangement of the domains of the polypeptide of Lieber-2. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Lieber-2 explicitly states that domain rearrangement is possible as long as they are arranged so that they function as a unit for their intended purpose.
Response to Arguments
Applicant asserts that the prior art does not teach the newly added limitation in claim 1 regarding improved delivery.
This is not found persuasive. As state above, Lieber-2 does in fact teach improved delivery. Additionally, same compositions must have the same properties.
Applicant asserts that Lieber-2 does not disclose conjugation through an amino acid.
This is not found persuasive because polypeptides are made of amino acids, thus this is the only way compounds could be could be conjugated thereto.
Applicant argues that amended claim 1 does not require specific order of the domain.
The relevance of this argument is unclear because it is not clear how this assertion differentiates the instant claims over Lieber-2.
Applicant asserts that the present application is related to conjugates useful for delivery to epithelial tissue.
The relevance of this argument is unclear as the instant claims are drawn to a polypeptide and not a method of use. As discussed above Lieber-2 teaches the same polypeptide conjugates as claimed. However, it is noted, that this is the same use as Lieber-2, as can be seen by the abstract.
Conclusion
No claims are allowed at this time.
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 Michael G Hartley whose telephone number is (571)272-0616. The examiner can normally be reached 10-6:30.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618