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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/6/2026 has been entered.
Response to Amendment
The amendment filed 07/06/2026 has been entered.
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-8, 10, 12, 14-16, 20, 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Lieber et al. (US2015/0246949A1; "Lieber-2"), for the reasons set forth in the office action mailed 02/05/2026.
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 conjugate-able moiety for conjugating compounds, e.g., for covalent attachment and isolation,
including CYB and CYD peptides (thus reading on new claim 37 comprising a cys), 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 show 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’s arguments filed 07/06/2026 have been fully considered but are not found persuasive.
Applicant asserts that the prior art does not teach the newly added limitation
in claim 1 regarding improved delivery and are not administered in combination with a polypeptide.
This is not found persuasive. As stated above, Lieber-2 does in fact teach
improved delivery. Additionally, same compositions must have the same properties.
Applicant’s arguments appear to be referring to method limitations to distinguish claims drawn to a product. Note the instant are drawn to a polypeptide which is clearly a product. Thus, the newly added limitation of “are administered in combination with the polypeptide” does not differentiate over the product as “administering” is a method step. At best, this is a functional limitation. However, as stated in the rejection Lieber-2 teaches a polypeptide comprising an Ad3 adenovirus fiber polypeptide shaft domain motif (reads on applicant's SEQ ID NO:1). This is the same polypeptide claimed. Thus, they must have the same properties. Note the instant claims do not necessitate or exclude any conjugation to “compounds” but only state “when conjugated” see wherein clause in claim 1. Any administration of the instant product or that of the prior art is not relevant in differentiating the instantly claimed product from the prior art.
Applicant also asserts that “why would one of ordinary skill in the art modify the co-administration system of the prior art to a conjugated system with a reasonable expectation of success.”
As stated above, the administration is not relevant to the product claims and the instant claims do not require said conjugation but state, “when conjugated” they have an improved delivery. As discussed Lieber-2 teaches the
same polypeptide conjugates as claimed and teaches their administration to a subject, thus are at least capable of meeting the same intended use and functional limitation as claimed. Applicant’s arguments fail to specifically state how the claimed product is different from that of the prior art.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at 5712721424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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