DETAILED ACTION
This action is in reply to papers filed 02/04/2026.
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 .
Election/Restrictions/Status of Claims
Applicant previously elected without traverse Group 1 and Species H (CELO virus), drawn to claims 1, 2, and 5-7, in the reply filed on 07/14/2025.
Claims 1 and 4 are pending and examined herein. Claim 4 previously depended from withdrawn claim 3, but has been amended to depend from claim 1.
Claims 8-22 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 2-3 and 5-7 are cancelled.
Objections and Rejections Rendered Moot
The cancellation of claims 2 and 5-7 renders objections and rejections thereof moot.
Drawings
The amended drawings filed 02/04/2026 are objected to because they do not include figures aside from corrected Fig. 3 and Fig. 5. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: The amended phrase “the aviadenoviral vector is derived a” (line 3) should read “the adenoviral vector is derived from a.” Appropriate corrections are required.
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 1 remains 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 1 recites the phrase “the aviadenoviral vector” (lines 3 and 4), which lacks antecedent basis. For purposes of examination, this phrase is interpreted as referring to the “aviadenoviral gene transfer vector” of line 1.
Claim 1 recites the phrase “aviadenoviral genome is partially deleted of open reading frames 1, 15, and 2” (line 8). It is unclear whether “partially deleted” describes the aviadenoviral genome, or open reading frames 1, 15, and 2. Thus, it is unclear whether this phrase means that a) the aviadenoviral genome comprises a partial deletion, which results in the deletion, which may be complete or partial, of open reading frames 1, 15, and 2, or b) the aviadenoviral genome comprises a partial deletion, which spans the entirety of open reading frames 1, 15, and 2. Interpretation (a) is the broadest reasonable interpretation of the claim, and will therefore be used for purposes of examination.
Claim 1 recites the phrase “wherein the open reading frames 1, 15, and 2 are partially replaced by heterologous transgenes” (lines 10-11). It is unclear whether this means that a) open reading frames 1, 15, and 2 are each partially replaced by a discrete heterologous transgene, or b) heterologous transgenes span across, but do not fully encompass, open reading frames 1, 15, and 2. The broadest reasonable interpretation of the claim, which includes both interpretations (a) and (b), will be used for purposes of examination.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 does not further limit the subject matter of claim 1. Claim 4, as amended, is drawn to the aviadenoviral gene transfer vector of claim 1, which is derived from a CLEO virus. Chiocca (Journal of Virology, 1996, 70(5): 2939-2949) shows that the CELO virus possesses no identifiable E1 region (Abstract). Therefore, the adenoviral gene transfer vector of claim 1, which is derived from a CELO virus, inherently does not comprise an E1 region.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 remains rejected, and amended claim 4 is rejected, under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Cotten (US 6,841,158 B1; cited in IDS filed 01/07/2025), as evidenced by Chiocca (Journal of Virology, 1996, 70(5): 2939-2949).
Regarding claim 1: Cotten discloses a recombinant CELO virus, which comprises a deletion at the left end of the viral genome (Abstract) and is useful as a vaccine for animals and for gene therapy and vaccine applications in humans (Abstract; reads on gene transfer vector). Cotten discloses that CELO based vectors are naturally replication defective in human cells (col 2, ln 21-25; col 7, ln 19-24).
Cotten discloses a CELO virus mutant with a deletion of nucleotides 40,065-43,684 (Fig 9; col 21, Table 2; claim 43) and a complete deletion, partial deletion, or an insertion of foreign DNA (reads on heterologous transgene) within the region spanning nucleotides 794-1330 (claim 44). The instant specification shows that nucleotides 40,037 through 42,365 of the CELO virus genome corresponds to ORFs 9, 10, and 11 (p 38, para 121; p 39, para 124; Fig. 1) and that nucleotides 794-1330 of the CELO virus genome corresponds to ORF 1 (p 38, para 123).
Regarding claim 4: The CELO virus possesses no identifiable E1 region, as evidenced by Chiocca (Abstract). Therefore, the CELO adenoviral vector disclosed in Cotten inherently does not comprise an E1 region.
Response to Arguments
Claim Rejections - 35 USC § 102
Applicant argues: Applicant respectfully submits that Cotten fails to disclose the claimed feature "wherein the aviadenoviral vector is replication deficient." To the contrary, Cotton expressly teaches replication-competent CELO viruses. For example, Cotten states at column 3, lines 48-52:
Apart from allowing the insertion of an expression cassette for genes, the recombinant CELO virus of the invention has been shown to be able to replicate without complementation both in LMH cells and in chicken embryos.
Thus, Cotten affirmatively discloses that the recombinant CELO virus is capable of replication without complementation. A reference that teaches replication-competent viral vectors does not disclose, either expressly or inherently, a replication-deficient aviadenoviral vector as required by the pending claims.
In response: Applicant’s arguments have been fully considered, but are not persuasive. Cotten discloses that CELO based vectors are naturally replication defective in human cells (col 2, ln 21-25; col 7, ln 19-24). Instant claim 1 recites the limitation “the adenoviral vector is replication deficient” (line 4). Claim 1 does not specify that the adenoviral vector is replication deficient in chicken cells, such as LMH cells, or in chicken embryos. Therefore, the teachings of Cotten anticipate the broadest reasonable interpretation of claim 1.
Applicant argues: Moreover, Cotten emphasizes the advantages of replication-competent viruses for use as vaccination vectors. For example, Cotten states at column 1, lines 46-55:
Furthermore, more robust immune responses might be expected from a replication competent virus; thus a vector is most useful in a host where replication is partially or fully permissive.
Accordingly, Cotten not only fails to disclose a replication-deficient aviadenoviral vector, but instead consistently teaches away from such vectors by highlighting the benefits of replication competence.
In response: Applicant’s arguments have been fully considered, but are not persuasive.
First, Cotten discloses that CELO based vectors are naturally replication defective in human cells (col 2, ln 21-25; col 7, ln 19-24). Moreover, Cotten states: “An additional conceptual advantage of CELO based vectors of the invention is that CELO, like the bovine, ovine, and canine adenoviruses, is naturally replication defective in human cells. Thus, replication of these vectors will not occur in human patients even in the presence of a wildtype human adenovirus infection” (col 7, ln 19-24). Therefore, Cotten teaches the advantages of using a naturally replication defective vector in human patients, and thus does not teach away from a replication-deficient aviadenoviral vector.
Furthermore, the question whether a reference “teaches away” from the invention is inapplicable to an anticipation analysis. See MPEP 2131.05, Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
Conclusion
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 Risa Takenaka whose telephone number is (571)272-0149. The examiner can normally be reached M-F, 12-7 EST.
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/RISA TAKENAKA/Examiner, Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632