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 .
Priority
This application is a continuation of application 15/552,163 filed on 08/18/2017, now abandoned. Applicant’s claim for the benefit of a prior-filed application provisional application 62/118,125 filed on 02/19/2015 and PCT/US16/18814 filed 02/19/2016 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/118,125 filed on 02/19/2015 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Regarding claim 1, the provisional application fails to provide support for a method of promoting site-specific nucleic acid integration into a host genome.
Additionally, regarding claims 17-19, the provisional application fails to provide support for the limitation of the AAV6 particle comprising a modified capsid protein comprising a non-tyrosine residue at a position that corresponds to a surface-exposed tyrosine residue in a wild-type AAV6 capsid protein, a non-threonine residue at a position that corresponds to a surface-exposed threonine residue in the wild-type AAV6 capsid protein, a non- lysine residue at a position that corresponds to a surface-exposed lysine residue in the wild-type AAV6 capsid protein, a non-serine residue at a position that corresponds to a surface-exposed serine residue in the wild-type AAV6 capsid protein, or a combination thereof, as well as the limitation of the modified capsid protein comprising a non-tyrosine residue and/or a non-threonine residue at one or more of or each of Y705, Y731, and T492 of a wild-type AAV6 capsid protein.
Accordingly, the effective priority date of the claims is granted as the filing date of PCT/US16/18814 filed 02/19/2016.
If applicant believes the earlier applications provide support for this disclosure, applicant should point out such support with particularity by page and line number in the reply to this Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/24/2024 is considered by the examiner.
Drawings
The drawings filed on 09/13/2024 are accepted.
Specification
The specification filed on 09/13/2024 is accepted.
Claim Objections
Claims 3 and 18 are objected to because of the following informalities:
It is recommended by the examiner to amend claim 3 to recite “wherein the rAAV particle is an AAV6 particle” to correct grammatical errors.
Additionally, it is recommended by the examiner to remove “or each of” from claim 18 for clarity, as “one or more of” reads on embodiment(s) where each residue is present.
Appropriate correction is 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 8 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 8 recites “the host cell is in situ in a host”. This recitation is unclear because in biology, “in situ” refers to methods to study a thing within its natural context but conducted outside of a living organism (e.g., studying a cell in a tissue sample, or nucleic acid in a cell), while “in vivo” refers to methods within a living organism (e.g., see Healthline NPL). Therefore, “in situ” and “in a host” contradict one another. As such, how can a host cell be in situ and also in a host? For examination purposes, claim 8 is interpreted to read on in situ and in vivo (e.g., a cell in a host) methods.
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(s) 1-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by University of Florida (US20140341852A1, published 11/20/2014).
Regarding claim 1, University of Florida discloses a method of promoting site-specific nucleic acid integration into a host genome (e.g., site-directed mutagenesis), the method comprising: delivering a recombinant adeno-associated virus (rAAV) particle comprising a nucleic acid vector to a host cell in the presence of a Rep protein (e.g., [0425], [0513]).
Regarding claim 2, University of Florida discloses the nucleic acid vector comprising AAV2 or AAV6 ITRs (e.g., [0425]).
Regarding claim 3, University of Florida discloses the particle being an AAV6 particle (e.g., [0541]).
Regarding claims 4-6, University of Florida discloses the host cell being a human liver, muscle, brain, eye, pancreas, kidney, or hematopoietic stem cell (e.g., [0031], [0034]).
Regarding claim 7 and 8, University of Florida discloses the host cell being ex vivo (e.g., cell or tissue culture from a host) or in a host (see 112(b) rejection above) (e.g., [0040], [0057]).
Regarding claim 9, University of Florida discloses the nucleic acid vector encoding the Rep protein (e.g., vector formed from triple plasmid transfection) (e.g., [0221]).
Regarding claims 10-13, University of Florida discloses the Rep protein being delivered to the host cell separately from the nucleic acid vector, and the Rep protein being expressed from a second nucleic acid that is delivered to the host cell. Additionally, University of Florida discloses the second nucleic acid being an mRNA that is transiently transfected into the host cell, as well as transfected into the host cell in a viral particle (e.g., plasmids used in triple transfection) (e.g., [0221], [0378], [0425]).
Regarding claims 14 and 15, University of Florida discloses the vector including a therapeutic protein, specifically human beta-globin (e.g., [0035]).
Regarding claim 16, University of Florida discloses the Rep protein being an AAV2 or AAV6 Rep protein (e.g., [0425]).
Regarding claims 17-19, University of Florida discloses the AAV6 particle comprising a modified capsid comprising a non-tyrosine residue and/or a non-threonine residue at one or more of or each of Y705, Y731, and T492 of a wild-type AAV6 capsid protein, wherein the non-tyrosine residue is phenylalanine and the non-threonine residue is valine (e.g.., AAV6-T492V+S663V vectors) (e.g., [0117], [0513]).
Claim(s) 1-4, 9-14, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Snyder (US20070015238A1, published 01/18/2007).
Regarding claim 1, Snyder discloses a method of promoting site-specific nucleic acid integration into a host genome (e.g., site-directed mutagenesis), the method comprising: delivering a recombinant adeno-associated virus (rAAV) particle comprising a nucleic acid vector to a host cell in the presence of a Rep protein (e.g., [0006], [0018])
Regarding claim 2, Snyder discloses the nucleic acid vector comprising AAV2 or AAV6 ITRs (e.g., [0006]).
Regarding claim 3, Snyder discloses the particle being an AAV6 particle (e.g., [0024]).
Regarding claim 4, Snyder discloses the host cell being a human cell (e.g., [0046]).
Regarding claim 9, Snyder discloses the nucleic acid vector encoding the Rep protein (e.g., vector formed from triple plasmid transfection) (e.g., [0041]).
Regarding claims 10-13, Snyder discloses the Rep protein being delivered to the host cell separately from the nucleic acid vector, and the Rep protein being expressed from a second nucleic acid that is delivered to the host cell. Additionally, Snyder discloses the second nucleic acid being an mRNA that is transiently transfected into the host cell, as well as transfected into the host cell in a viral particle (e.g., plasmids used in triple transfection to form vector) (e.g., [0041]).
Regarding claim 14, Snyder discloses the vector including a therapeutic protein, (e.g., [0038]).
Regarding claim 16, Snyder discloses the Rep protein being an AAV2 or AAV6 Rep protein (e.g., [0008]).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M JOHNSON whose telephone number is (703)756-1396. The examiner can normally be reached Monday-Friday 9am-5pm.
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ALLISON M. JOHNSON
Examiner
Art Unit 1638
/ALLISON MARIE JOHNSON/ Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights