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
Claim status
Claims 1-20 are pending
Claims 12-20 are withdrawn
Claims 1-11 are under examination
Election/Restrictions
Applicant’s election of the following invention without in the reply filed on 2/13/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 1-11 and 13, drawn to a composition of vectors and kits, thereof.
Claim 12, and 14-20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable linking claim.
Applicant’s election of the following species is acknowledged.
Claim 1-11, drawn to a kit comprising a first and second vector.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/28/2023, 1/10/2025 10/21/2025, 2/24/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 3-11 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.
Claims 3-6 recite the limitation "the virus helper gene" in regard to Claim 1. There is insufficient antecedent basis for this limitation in the claims because Claim 1 is directed to “one or more virus helper genes”, thereby rendering instant claims indefinite as to which helper gene is encompassed by the scope of the claim. Dependent claims 7 & 8 are included in the basis of this rejection as dependent on claim 6, and not clarifying the one or more helper genes.
Claims 4-5 recite the limitation "a promoter capable of regulating expression" in regard to Claim 1. There is insufficient antecedent basis for this limitation in the claims because Claim 1 is also directed to “a promoter capable of regulating expression”, thereby rendering instant claims indefinite as to which promoter is encompassed by the scope of the claim.
Claims 9-10 recite the limitation " a promoter regulating expression by a drug" in regard to Claim 1. There is insufficient antecedent basis for this limitation in the claims because Claim 1 is also directed to “a promoter regulating expression by a drug”, thereby rendering instant claims indefinite as to which promoter is encompassed by the scope of the claim.
Claim 11 recites the limitation "the adeno-associated virus genes" in regard to Claim 1. There is insufficient antecedent basis for this limitation in the claims because Claim 1 is directed to “one or more adeno-associated virus genes”, thereby rendering instant claims indefinite as to which AAV gene is encompassed by the scope of the claim.
Appropriate correction is required.
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.
Claims 1, 3-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agilent (AAV Helper-Free System, Instruction Manual, rev. D0-2015, pgs 1-48, on-line 3/21/2016), as evidenced by Colosi et al., (US 7,037,713, filed 2/11/2002, patented 5/02/2006).
With respect to claim 1, Agilent teaches a kit comprising
[AltContent: textbox ([img-media_image1.png])]a first plasmid vector “pHelper” containing adenoviral helper genes E2A, E4 and VA RNA; and
a second plasmid vector “pAAV-RC” containing AAV genes Rep and Cap (see Fig. 1 excerpt adjacent).
In regard to the promoter capable of regulating expression of the adenoviral helper genes, Agilent cites their US Patents covering the disclosed technology (p. 2, 2nd para.). Specifically, US Patent 7,037,713 evidences the 11.6 kb pHelper plasmid (see Fig. 7 of Instructions of Agilent) contains the E2A, VA RNA, and E4 genes taken from a genomic fragment of adenovirus-2 with the proximal promoters intact (col 16, 3rd para. of Colosi), and it is well known that the adenoviral E2A gene promoter is primarily regulated by the adenoviral E1A protein. E1A (specifically the 13S product) acts as a transcriptional activator for the E2A early promoter.
In regard to the promoter not regulated by expression of a drug, again US Patent 7,037,713 evidences the 7.3 kb pAAV-RC plasmid (see Fig. 7 of Instructions) contains the Rep and Cap genes taken from a 4.3 kb genomic fragment of AAV-2 further comprising a TATA modified p5 promoter (col 15-16, 2nd para. of Colosi). Importantly, the native p19 and p40 promoters for Rep and Cap production are intact (see Fig. 4 of Colosi).
In regard to claim 3, as stated supra, the helper genes are derived from adenovirus 2.
In regard to claims 4 and 5, the phrase “a” promoter has been interpreted to include more than one promoter, and the pHelper plasmid comprises the regulated E2A promoter and E4 promoter abutting thereby causing the regions to be transcribed away from each other, while the promoter of the VA RNA genes directs transcription towards the E4 gene.
In regard to claim 6, as stated supra, the helper genes include E2A, E4 and VA RNA.
In regard to claim 7, Colosi evidences that an “intact” E4 region of about 3 kb was cloned into the pHelper, which naturally comprises the E4ORF6 gene.
In regard to claim 8, Colosi evidences that all VA RNAs of about 700 bp was cloned into the pHelper, which naturally comprises both the VA-I and VA-II RNAs.
In regard to claims 9-10, as stated supra, the AAV-RC genes are operably linked to promoters naturally carried by AAV (e.g., p19 and p40).
In regard to claim 11, as stated supra, the pAAV-RC genes include a Rep and Cap genes.
Accordingly, Agilent, as evidenced by Colosi, anticipates instant claims.
Claim Rejections - 35 USC § 103
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gao US 6,953,690, filed 9/20/2000, patented 10/11/2005), in view of Orberger et al., (WO 2002/38782, filed 11/13/2001, published 5/16/2002).
Gao teaches a composition comprising:
a first plasmid vector comprising the adenovirus helper gene E2A under control of a dex-inducible mouse mammary tumor virus promoter (i.e., pMMTV-E2A); and
a second plasmid comprising the AAV Rep and Cap genes under the control of the native p5 promoter (i.e., pP5-Rep/Cap) (Example 3, cols 21-22, see Fig. 3).
However, although Gao teaches these plasmids are for helper-free rAAV production in human cells, they are silent with respect to a kit comprising the vectors.
Nevertheless, Orberger teaches plasmid kits for the making of AAV vectors (see claims 33-36 of Orberger translation).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the composition of plasmid vectors as taught by Gao for helper-free production of rAAV and to combine them into a kit as taught by Orberger with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Orberger because having the plasmids in a kit with the different vectors being present in different compartments or container would improve convenience for transfecting host cells.
In regard to claim 3, as stated supra, the helper gene is derived from adenovirus.
In regard to claim 5, all of the helper genes (i.e., E2A) are under control of the MMTV promoter.
In regard to claims 9-10, as stated supra, the AAV Rep and Cap genes are operably linked to promoters naturally carried by AAV (e.g., p5).
In regard to claim 11, as stated supra, the AAV genes include Rep and Cap genes.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
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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