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 .
Detailed Action
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 11/12/2025 is acknowledged.
Priority
Applicant' s claim for the benefit of a prior-filed parent provisional application 63/326,415, filed on 04/01/2022 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The effective priority for the instant application is 04/01/2022.
Claims Status
Claims 2-4, 6, 7, and 9-11 are canceled, no claims are newly added, claims 14-20 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1, 5, 8, 12-13 have been considered on the merits. All arguments have been considered.
Withdrawn Objections & Rejections
Applicant's response filed 06/17/2026 has been considered. Rejections and/or objections not reiterated from the previous Office action mailed 03/17/2026 are hereby withdrawn. The claim objection and the claim rejections under 112(a), 102 and 103 as recited in the previous action are withdrawn due to the amendments to the claims, as discussed further below in the Response to Arguments.
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application.
Claim Rejections - 35 USC § 112
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 12 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.
Claim 12 is indefinite because it is dependent on cancelled claim 11. For purposes of compact prosecution claim 12 is examined as dependent on claim 8.
Claim Rejections - 35 USC § 103 (New)
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.
Claims 1, 5, 8 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over by Roy et al (Scientific Reports (2016) 6:22067;1-14; cited previously) in view of Nakagawa et al (JAMA Otolaryngology (2009) 135:3;1-12; “Cyclooxygenase 2 Promoter–Based Replication-SelectiveAdenoviral Vector for Hypopharyngeal Cancer”), Unoki et al (Oncogene (2001) 20:1-9; “Growth-suppressive e€ects of BPOZ and EGR2, two genes involved in the PTEN signaling pathway”), Mezzina et al (Viral Vectors for Gene Therapy (2011) Chapter 9 Adeno-Associated Viruses; Merten and Al-Rubeai (Eds.) Springer Science+Buisiness Media, LLC; cited previously) and as evidenced by Lv104 datasheet (OmicsLink Lv104 [online]. GeneCopoeia corporation [retrieved on 03/09/2026]. Retrieved from the Internet: <URL: https://www.genecopoeia.com/wp-content/uploads/oldpdfs/tech/omicslink/pReceiver-Lv104.pdf; cited previously)
The rejection is necessitated by the amendments to the claims, but relies upon some previous art of record.
Regarding claims 1, 5, 8 and 12: Roy teach a viral vector comprising a nucleic acid encoding an ankyrin-rich BTB/POZ domain containing protein-2 (ABTB2), or bpoz-2 gene (abstract). Roy further teach BPOZ-2 is an ankyrin repeat and BTB/POZ domain containing protein-2 (p1 ¶1). Thus, absent evidence to the contrary ABTB2 and bpoz-2 are considered equivalent.
Roy teach the Bpoz-2 over expression construct was purchased from Genecopoeia (EX-Mm12657-Lv104) (p12 ¶3). The Lv104 datasheet shows the pReceiver-Lv104 vector comprises a CMV promoter (Lv104 datasheet).
Roy do not teach the vector comprises a Cox-2 promoter.
Nakagawa teach COX-2 is virtually undetectable in most tissues under physiologic conditions, but is upregulated in various cancers (p2 ¶6). Nakagawa further teach tumor specific expression of a transgene by using the Cox-2 promoter to drive transgene expression in Cox-2 expressing carcinoma (p7 ¶2).
It would have been obvious to one of ordinary skill in the art to modify the vector of Roy using the Cox-2 promoter to drive transgene expression, as taught by Nakagawa.
One of ordinary skill in the art would have been motivated to modify the vector as taught by Roy by using the Cox-2 promoter to drive transgene expression, as taught by Nakagawa, because Nakagawa teach the Cox-2 promoter drives transgene expression in Cox-2 expressing carcinomas.
One would have been motivated to drive BPOZ expression in Cox-2 expressing carcinomas because Unoki teach BPOZ has tumor-suppressive function which may function for a wide range of human cancers (p4 col1 ¶1, p7 col1 ¶3).
One would have had a reasonable expectation of success because Nakagawa discloses use of the Cox-2 promoter to drive tumor specific transgene expression delivered by a viral vector.
While Roy teach vector is a lentiviral vector (Figure 2A), Roy do not teach the viral vector is an adeno-associated viral vector.
Mezzina teach AAV vectors are safer than lentiviral vectors because AAV vectors are non-pathogenic and AAV vectors stay essentially episomal after gene transfer and therefore do not mediate insertional mutagenesis (p211 Abstract).
Mezzina further teach that AAV2 (AAV type 2) is the best characterized serotype, and the majority of gene transfer studies have been based on the AAV2 serotype (p212¶4).
It would have been obvious to one of ordinary skill in the art to modify the vector of Roy drawn to a lentiviral vector comprising a nucleic acid encoding ABTB2 by using an AAV2 vector as taught by Mezzina.
One of ordinary skill in the art would have been motivated to modify the teaching of Roy to use an AAV2 vector as taught by Mezzina in place of a lentiviral vector as taught by Roy because Mezzina teach lentivirus do not mediate insertional mutagenesis, and that the AAV2 serotype has been used for the majority of gene transfer studies.
One would have had a reasonable expectation of success because Mezzina discloses AAV2 has been used for the majority of gene transfer studies and one of ordinary skill in the art would understand that there is guidance for use of the vector in the art and thus the results would be predictable.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Regarding claim 13: The teachings of Roy are discussed above.
While the instant claim recites “pharmaceutical composition”. The term “pharmaceutical” does not impose or imply structure on the claimed composition.
Roy teach mice were injected with lentiviral particles of pboz-2 overexpression constructs (p12 ¶4). Injection of mice requires a pharmaceutical composition and thus reads on the “pharmaceutical composition” if the term did impart structure on the claimed composition.
Response to Arguments
The responses are directed to the Arguments filed 06/17/2026, all Arguments are considered.
Regarding Arguments directed to the objections:
Applicant's argument that the cancellation of claim 3 overcomes the objection is persuasive. The objection is withdrawn.
Regarding Arguments directed to 35 USC § 112(d):
Applicant's argument that the cancellation of claim 11 overcomes the rejection is persuasive. The rejection is withdrawn.
Regarding Arguments directed to 35 USC § 102:
Amended claims 1 and 8 recite limitations not addressed in the previous rejection; specifically the claims recite an adeno-associated viral vector and a promoter selected the group consisting of a Cox-2 promoter, a P48 promoter, a Pdx1 promoter, a Hnf6 promoter, a ngn3 promoter, a MAFA promoter, a Pax6 promoter, and a Pax4 promoter. Thus the amendments to the claims overcome the rejection as written and the rejection is withdrawn.
Regarding arguments relevant to the instant rejection; Applicant submits Roy et al fail to teach an adeno-associated viral vector. As discussed above in the new rejection under 103:
While Roy teach vector is a lentiviral vector (Figure 2A), Roy do not teach the viral vector is an adeno-associated viral vector.
Mezzina teach AAV vectors are safer than lentiviral vectors because AAV vectors are non-pathogenic and AAV vectors stay essentially episomal after gene transfer and therefore do not mediate insertional mutagenesis (p211 Abstract).
Mezzina further teach that AAV2 (AAV type 2) is the best characterized serotype, and the majority of gene transfer studies have been based on the AAV2 serotype (p212¶4).
It would have been obvious to one of ordinary skill in the art to modify the vector of Roy drawn to a lentiviral vector comprising a nucleic acid encoding ABTB2 by using an AAV2 vector as taught by Mezzina.
One of ordinary skill in the art would have been motivated to modify the teaching of Roy to use an AAV2 vector as taught by Mezzina in place of a lentiviral vector as taught by Roy because Mezzina teach lentivirus does not mediate insertional mutagenesis, and that the AAV2 serotype has been used for the majority of gene transfer studies.
One would have had a reasonable expectation of success because Mezzina discloses AAV2 has been used for the majority of gene transfer studies and one of ordinary skill in the art would understand that there is guidance for use of the vector in the art and thus the results would be predictable.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Regarding Arguments directed to 35 USC § 103:
Claims 4-5 and 10-12 depend from claims 1 and 8 and thus the amendments to the claims overcome the rejection as written and the rejection is withdrawn.
In response to arguments relevant to the instant rejection regarding claim 13: Applicant argues that Roy et al fails to teach a pharmaceutical composition comprising ABTB2 as recited in claim 8.
As discussed the instant rejection above;
The claims recite “pharmaceutical composition”. The term “pharmaceutical” does not impose or imply structure on the claimed composition.
Roy teach a viral vector comprising a nucleic acid encoding an ankyrin-rich BTB/POZ domain containing protein-2 (ABTB2) or bpoz-2 gene (abstract). Roy further teach BPOZ-2 is an ankyrin repeat and BTB/POZ domain containing protein-2 (p1 ¶1). Thus, absent evidence to the contrary ABTB2 and bpoz-2 are considered equivalent.
Roy teach the Bpoz-2 over expression construct was purchased from Genecopoeia (EX-Mm12657-Lv104) (p12 ¶3). The Lv104 datasheet shows the pReceiver-Lv104 vector comprises a CMV promoter (Lv104 datasheet).
Roy do not teach the vector comprises a Cox-2 promoter.
Nakagawa teach COX-2 is virtually undetectable in most tissues under physiologic conditions, but is upregulated in various cancers (p2 ¶6). Nakagawa further teach tumor specific expression of a transgene by using the Cox-2 promoter to drive transgene expression in Cox-2 expressing carcinoma (p7 ¶2).
It would have been obvious to one of ordinary skill in the art to modify the vector of Roy using the Cox-2 promoter to drive transgene expression, as taught by Nakagawa.
One of ordinary skill in the art would have been motivated to modify the vector as taught by Roy by using the Cox-2 promoter to drive transgene expression, as taught by Nakagawa, because Nakagawa teach the Cox-2 promoter drives transgene expression in Cox-2 expressing carcinomas.
One would have been motivated to drive BPOZ expression in Cox-2 expressing carcinomas because Unoki teach BPOZ has tumor-suppressive function which may function for a wide range of human cancers (p4 col1 ¶1, p7 col1 ¶3).
One would have had a reasonable expectation of success because Nakagawa discloses use of the Cox-2 promoter to drive tumor specific transgene expression delivered by a viral vector.
While Roy teach vector is a lentiviral vector (Figure 2A), Roy do not teach the viral vector is an adeno-associated viral vector.
Mezzina teach AAV vectors are safer than lentiviral vectors because AAV vectors are non-pathogenic and AAV vectors stay essentially episomal after gene transfer and therefore do not mediate insertional mutagenesis (p211 Abstract).
Mezzina further teach that AAV2 (AAV type 2) is the best characterized serotype, and the majority of gene transfer studies have been based on the AAV2 serotype (p212¶4).
It would have been obvious to one of ordinary skill in the art to modify the vector of Roy drawn to a lentiviral vector comprising a nucleic acid encoding ABTB2 by using an AAV2 vector as taught by Mezzina.
One of ordinary skill in the art would have been motivated to modify the teaching of Roy to use an AAV2 vector as taught by Mezzina in place of a lentiviral vector as taught by Roy because Mezzina teach lentivirals do not mediate insertional mutagenesis, and that the AAV2 serotype has been used for the majority of gene transfer studies.
One would have had a reasonable expectation of success because Mezzina discloses AAV2 has been used for the majority of gene transfer studies and one of ordinary skill in the art would understand that there is guidance for use of the vector in the art and thus the results would be predictable.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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 ANDREA LYNNE MORRIS SPENCER whose telephone number is (571)272-3328. The examiner can normally be reached Monday-Friday 9:00-5:00.
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/ANDREA LYNNE MORRIS SPENCER/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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