DETAILED ACTION
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
Applicant's election with traverse of Group I in the reply filed on 11/12/2025 is acknowledged. The traversal is on the ground(s) that the statement of burden is unsupported.
This is not found persuasive because burden consists not only of specific searching of classes and subclasses, but also of searching multiple databases for foreign references and literature searches. Burden also resides in the examination of independent claim sets for clarity, enablement and double patenting issues.
The requirement is still deemed proper and is therefore made FINAL.
Claims Status
The duplicate claim 12 has been canceled, no claims are newly added, claims 14-20 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-13 have been considered on the merits. All arguments have been considered.
Withdrawn Objections & Rejections
Applicant's response filed 11/12/2025 has been considered. Rejections and/or objections not reiterated from the previous Office action mailed 09/25/2025 are hereby withdrawn.
The objections in regards to claims 12 and 13 as recited in the action mailed 09/25/2025 are withdrawn in view of the claim amendments filed 11/12/2025.
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application.
Claim Objections
Regarding claim 3: The claim recites the “non-viral vector is a lentiviral vector”. This is considered a typographical error because lentiviral vectors are viral vectors. The claim is interpreted as “the viral vector is a lentiviral vector” and the claim is interpreted as such.
Appropriate correction is required.
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.
Regarding claim 11: The claim is not a complete sentence. The claim recites “wherein adeno-associated viral vector”. The claim is interpreted as “wherein the vector is an adeno-associated viral vector”.
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 11 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.
Regarding Claim 11: The claim requires the viral vector of claim 10 to be an adeno-associated viral vector. Claim 10 already requires the vector to be an adeno-associated viral vector. Therefore claim 11 fails to further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 6, 8-9 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roy et al (Scientific Reports (2016) 6:22067;1-14) and 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).
Regarding claims 1-3: Roy et al teach lentiviral administration of ankyrin-rich BTB/POZ domain containing protein-2, or bpoz-2 gene, decreases alpha-syn in mouse neurons (abstract). Roy teach GFP-linked BPOZ-2 is packaged in lentiviral particles and delivered to the mouse brain (Figure 2A). This reads on a lentiviral vector as required by the instant claims.
Regarding claim 6: 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).
Regarding claims 8-9 and 13: 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 instant claim limitations. Lentiviral particles read on “a viral vector” as required by claim 9.
Thus, the reference anticipates the claimed invention.
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 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 4-5, 7 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Roy et al as applied to claim 1-3, 6, 8-9 and 13 above, and further in view of Mezzina et al (Viral Vectors for Gene Therapy (2011) Chapter 9 Adeno-Associated Viruses; Merten and Al-Rubeai (Eds.) Springer Science+Buisiness Media, LLC).
Claims 1-3, 6, 8-9 and 13 are anticipated by Roy and thus are also rendered the claims obvious (see above).
Regarding claims 4-5, 10-12: The teachings of Roy are discussed supra. Roy do not teach the vector is an AAV 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 replace the lentiviral vector of Roy drawn to a nucleic acid encoding ABTB2 with an AAV2 vector as taught by Mezzina.
One of ordinary skill in the art would have been motivated to replace the lentiviral vector as taught by Roy with an AAV2 vector as taught by Mezzina because Mezzina teach lentivirals are non-pathogenic and 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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Roy et al as applied to claim 1-3, 6, 8-9 and 13 above, and further in view of Jeong et al (Eur J Nucl Med Mol Imaging (2013) 40:1607-1617).
Claims 1-3, 6, 8-9 and 13 are anticipated by Roy and thus are also rendered the claims obvious (see above).
Regarding claim 7: The teachings of Roy are discussed supra. As discussed supra, Roy teach the promoter is a CMV promoter. Roy do not teach the promoter is a NeuroD/BETA2 promoter.
Jeong teach the NeuroD promoter drives expression of a reporter transgene (luciferase) in neural cells (p1607 ¶1, p1608 ¶2).
It would have been obvious to one of ordinary skill in the art to adapt the vector of Roy drawn to a vector comprising a CMV promoter by using the NeuroD promoter as taught by Jeong.
One of ordinary skill in the art would have been motivated to modify the vector as taught by Roy by using the NeuroD promoter as taught by Jeong because Jeong teaches the NeuroD promoter is a neuronal promoter (p1611 col2 ¶2) and the invention of Roy is directed to administration of bpoz-2 in neurons (abstract).
One would have had a reasonable expectation of success because Jeong teaches that, as expected, NeuroD promoter activity was increased in cells that also expressed neuron-specific markers (p1614 col1/2 ¶4/1).
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.
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/ANDREA LYNNE MORRIS SPENCER/Examiner, Art Unit 1631
/TAEYOON KIM/Primary Examiner, Art Unit 1631