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 .
Amendments
In the reply filed 5/01/2026, Applicant has amended Claims 1 and 20, and cancelled claims 4-19.
Claims 1-3 and 20 are under consideration.
Withdrawn 35 USC § 102
The prior rejection of Claim 20 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by O’Shea (WO2016/049201, filed 9/23/2015, published 3/31/2016, see IDS filed 4/19/2023) is withdrawn in light of Applicant’s amendment of instant claim to limit the adenovirus to comprising SEQ ID NO:6, which is a limitation O’Shea does not teach.
Withdrawn 35 USC § 103
The prior rejection of Claims 1 and 3 under 35 U.S.C. 103 as being unpatentable over Betz et al., (US 2005/0136042, filed 8/11/2004, see IDS filed 4/19/2023), in view of Lieber et al., (US 7,094,398, filed 6/01/2000, see IDS filed 4/19/2023) is withdrawn in light of Applicant’s amendment of instant claim to limit the adenovirus to comprising SEQ ID NO:6, which is a limitation neither Betz nor Liber teach.
The prior rejection of Claim 2 under 35 U.S.C. 103 as being unpatentable over Betz et al., (US 2005/0136042, filed 8/11/2004, see IDS filed 4/19/2023), in view of Lieber et al., (US 7,094,398, filed 6/01/2000, see IDS filed 4/19/2023), as applied to claim 1, in further view of Baltzer et al., (US 7,105,494, filed 4/28/2000, see IDS filed 4/19/2023) is withdrawn in light of Applicant’s amendment of instant claim to limit the adenovirus to comprising SEQ ID NO:6.
Allowed Claims
In view of Applicant’s amendments to the claims and arguments of record, the rejections of record are withdrawn.
Claims 20 is allowed.
The closes prior art does not teach nor reasonably suggest a synthetic adenovirus comprising SEQ ID NO:6.
Specifically, the closest prior O’Shea (US2013/0231267, filed 2/15/2013, published 9/05/2013, see IDS filed 6/1/2023), teaches methods and compositions for expressing a transgene in a subject comprising a synthetic adenovirus comprising a chimeric fiber protein (Abstract, [0002-0009]). Furthermore, O’Shea (2013) teaches the nucleic acid sequences for an E1/E3 modified synthetic Ad5 vector comprising a GFP-luciferase reporter gene, SV40 polyA containing two copies of a miR-122 binding site, a hexon with a E451Q substitution, and an Ad5/11 chimeric fiber protein comprising the fiber stem of Ad5 and the knob domain of Ad11 (see map from Fig. 43 below, as well as Fig. 44 “Ad5/11 EF1a-GFP”, and “E3-031” from Table 3, p. 25).
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150
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However, the prior art O’Shea does not teach the synthetic adenovirus comprising SEQ ID NO:6, which is 40,150 nucleotides in length encoding the adenovirus AdSyn-CO277 vector, which comprises an Ad5 backbone, a DE1-EF1a-Cre-miR122 construct, a chimeric Ad5/Ad11 fiber knob, and hexon with a E451Q substitution.
New 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.
Claims 1-3 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 1 recites the broad recitations wherein the adenovirus comprises a “transgene”, and has a “Ad11” fiber protein or chimeric fiber protein, and the claim also recites that the adenovirus comprises “SEQ ID NO: 6”, which is the narrower statement of the limitations because SEQ ID NO: 6 encodes for the specific Cre recombinase transgene, and has a chimeric Ad5/Ad11 fiber knob (see p. 27, Example 2 of Applicant’s specification). Claims 2 and 3 are included in the basis of this rejection because they do not clarify the transgene or fiber knob.
New 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 3 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.
Specifically, claim 3 draws to a method of expressing a transgene comprising administering a synthetic adenovirus comprising a transgene that is a reporter gene, which does NOT narrow the scope of claim 1 where the transgene is a Cre recombinase (as encoded by SEQ ID NO: 6). Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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