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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3-13-26 has been entered.
Claims 2, 3, 5, 6, 13, 16-31, 33, 44 have been canceled. Claims 1, 4, 7-12, 14, 15, 32, 34-43, 45-49 remain pending.
Applicant's arguments filed 3-13-26 have been fully considered but they are not persuasive.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
The heading for Group I on pg 3 of the Restriction sent 10-23-24 had an error: It should have said ---Claims 1, 4, 7-12, 14, 15, 18, 32-49…--- as inferred from the inclusion of “method of treatment using the vector (claims 18, 32-42)” in the description of Group I. Applicants elected Group I, claims 1, 4, 7-12, 14, 15, 34-49, in the reply filed on 1-23-25. Applicants mentioned claim 30 and Group II at the bottom of pg 7 of the response filed 1-23-25 without traversing the Restriction. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election was treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, 4, 7-12, 14, 15, 32, 34-43, 45-49 remain under consideration.
Claim interpretation
The active step of “administering” in claim 32 has functional language indicating the “administering” causes a therapeutic effect, i.e. “wherein one or more symptoms of RP are ameliorated in the mammal”.
Claim objections
The language about the host cell at the bottom of claim 43 should be with the host cells in line 3 of claim 43; it should be consolidated and simplified, i.e. transfecting isolated packaging cells containing at least one helper plasmid with a plasmid encoding an AAV vector comprising i) a small hairpin… … SEQ ID NO: 42.
The steps of claim 43 should be delineated using a), b), c).
The phrase “to allow for AAV particle production” in claim 43 is an intended use and does not necessarily have to occur. The step can be written more clearly with functional language that says what must occur or is a “capability” of the “incubating” step, i.e. incubating the transfected packaging cells such that AAV particles are obtained.
The purifying step can be written more clearly to refer to the AAV particles obtained in step b) of claim 43, i.e. purifying the AAV particles from the packaging cells.
Claim 48 can be written more clearly as ---wherein the transfecting is performed using CaPO4, lipids, or polymeric molecules---.
Claim Rejections - 35 USC § 112
Written Description
Claims 1, 4, 7-12, 14, 15, 32, 34-42, 47, 49 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Withdrawn rejections
The rejection regarding claim 43 has been withdrawn in view of pg 10, lines 1-3, which teaches a single adeno-associated virus (AAV) vector is used to deliver both the RNA agent (e.g., small hairpin RNA or artificial microRNA) and the recombinant RHO gene and because the claim has been limited to making an AAV particle using a plasmid encoding an AAV vector that comprises both the shRNA and the sequence encoding RHO.
The rejection regarding therapeutic embodiments have been withdrawn in view of Example 8, pg 40, lines 5-13, and Fig. 19-22.
The rejection regarding administering the composition of claim 11 to the eye of a mammal with RP “associated with a mutant endogenous RHO allele” such that one or more symptoms of RP are ameliorated in the mammal as broadly encompassed by claim 32 has been withdrawn because claim 32 has been limited to administering a vector encoding the shRNA and RHO to a mammal whose genome comprises a mutant RHO allele.
The rejection regarding making an AAV particle by transfecting any host cell with an AAV vector as broadly encompassed by claim 43 other than transfecting an isolated packaging cell with a plasmid encoding a AAV vector along with a helper plasmid has been withdrawn in view of the amendment.
Pending rejection
The specification lacks written description for any vector containing the shRNA and the sequence encoding RHO as required in claim 1 other than an AAV vector or using any vector to treat a mammal that has RP and a mutant RHO gene as required in claim 32 other than an AAV particle.
Claim 1 is drawn to a vector comprising i) a nucleic acid encoding a shRNA molecule comprising the nucleic acid sequences of SEQ ID NO: 7+8; and ii) a nucleic acid sequence encoding RHO comprising the nucleotide sequence of SEQ ID NO: 42.
Claim 32 is drawn to a method of treating RP by administering a composition comprising the vector of claim 1 to the eye a mammal that has RP and a mutant RHO gene such that symptoms of RP are ameliorated.
The claims encompass a vector that is a plasmid that does not encode an AAV vector. The claims encompass vector that is a retrovirus, a lentivirus, an adenovirus, an adeno-associated virus, etc.
Pg 2, lines 16-20; pg 10, lines 1-3; pg 25, lines 6-8; pg 28, lines 15-17 teach a single adeno-associated virus (AAV) vector is used to deliver both the RNA agent (e.g., small hairpin RNA or artificial microRNA) and the recombinant RHO. Example 8, pg 36, lines 3-5, describes an AAV encoding the shRNA and RHO. Fig. 12C shows an AAV encoding the shRNA and RHO.
The examples are limited to an AAV vector comprising shRNA (pg 23, lines 25-31) and an AAV vector encoding RHO (pg 24, lines 19-22) sometimes on the same AAV vector (pg 25, lines 6-8; Fig. 12C).
The examples are limited to administering AAV particles in vivo (pg 25, lines 3-13; pg 28, lines 7 & 14).
The specification does not contemplate any vector that is a plasmid that does not encode an AAV vector as broadly encompassed by claims 1 and 32. The specification does not contemplate any vector that is a retrovirus, a lentivirus, an adenovirus, etc. other than an AAV vector as broadly encompassed by claims 1 and 32.
The specification does not correlate administering an AAV particle to a mammal to administering just the AAV vector in the absence of a viral particle as broadly encompassed by claim 32. The specification does not contemplate administering a vector that is a plasmid that does not encode an AAV vector as broadly encompassed by claim 32. The specification does not contemplate administering any vector or viral particles that are a retrovirus, a lentivirus, an adenovirus, etc. other than an AAV vector as broadly encompassed by claim 32.
Accordingly, the specification lacks written description for any vector containing the shRNA and the sequence encoding RHO as required in claim 1 other than an AAV vector or using any vector to treat a mammal that has RP and a mutant RHO gene as required in claim 32 other than an AAV particle.
Response to arguments
Applicants arguments are noted but do not address this aspect of the rejection.
New rejections
The specification lacks written description for using BHK or Sf9 packaging cells for making AAV viral particles as encompassed by claim 47. Claim 47 is drawn to making AAV particles using HEK293, BHK or Sf9 packaging cells. However, the specification is limited to making AAV particles using HEK293 packaging cells (pg 23, lines 8-9). Sf9 packaging cells are limited to making baculovirus (pg 22, line 9-11). BHK packaging cells are limited to making HSV (pg 22, line 11-13). The specification does not teach making AAV particles in BHK or Sf9 packaging cell lines. Accordingly, the specification lacks written description for using BHK or Sf9 packaging cells for making AAV viral particles as encompassed by claim 47.
The specification lacks written description for using Sf9 packaging cells to make baculovirus particles as encompassed by claim 49. Claim 49 is drawn to making AAV particles using Sf9 packaging cells and a “baculovirus containing the viral vector”. However, the specification is limited to making AAV particles using HEK293 packaging cells (pg 23, lines 8-9). Sf9 packaging cells are limited to making baculovirus (pg 22, line 9-11). BHK packaging cells are limited to making HSV (pg 22, line 11-13). The specification does not teach making AAV particles in Sf9 packaging cell lines using a baculovirus. Accordingly, the specification lacks written description for using Sf9 packaging cells and a baculovirus for making AAV viral particles as required in claim 49.
Enablement
Claims 1, 4, 7-12, 14, 15, 32, 34-42, 47, 49 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an AAV vector encoding RHO and an shRNA comprising SEQ ID NO: 7+8, and administering an AAV particle encoding RHO and an shRNA comprising SEQ ID NO: 7+8 to the eye of a mammal the has RP and a mutant RHO allele such that one or more symptom of RP is ameliorated does not reasonably provide enablement for any vector encoding shRNA and RHO or administering any vector other than an AAV particle. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
Withdrawn rejections
The rejection regarding claim 43 has been withdrawn in view of pg 10, lines 1-3, which teaches a single adeno-associated virus (AAV) vector is used to deliver both the RNA agent (e.g., small hairpin RNA or artificial microRNA) and the recombinant RHO gene and because the claim has been limited to making an AAV particle using a plasmid encoding an AAV vector that comprises both the shRNA and the sequence encoding RHO.
The rejection regarding therapeutic embodiments have been withdrawn in view of Example 8, pg 40, lines 5-13, and Fig. 19-22.
The rejection regarding administering the composition of claim 11 to the eye of a mammal with RP “associated with a mutant endogenous RHO allele” such that one or more symptoms of RP are ameliorated in the mammal as broadly encompassed by claim 32 has been withdrawn because claim 32 has been limited to administering a vector encoding the shRNA and RHO to a mammal whose genome comprises a mutant RHO allele.
The rejection regarding making an AAV particle by transfecting any host cell with an AAV vector as broadly encompassed by claim 43 other than transfecting an isolated packaging cell with a plasmid encoding a AAV vector along with a helper plasmid has been withdrawn in view of the amendment.
Pending rejection
The does not enable making/using any vector containing the shRNA and the sequence encoding RHO as required in claim 1 other than an AAV vector or using any vector to treat a mammal that has RP and a mutant RHO gene as required in claim 32 other than an AAV particle.
Claim 1 is drawn to a vector comprising i) a nucleic acid encoding a shRNA molecule comprising the nucleic acid sequences of SEQ ID NO: 7+8; and ii) a nucleic acid sequence encoding RHO comprising the nucleotide sequence of SEQ ID NO: 42.
Claim 32 is drawn to a method of treating RP by administering a composition comprising the vector of claim 1 to the eye a mammal that has RP and a mutant RHO gene such that symptoms of RP are ameliorated.
The claims encompass a vector that is a plasmid that does not encode an AAV vector. The claims encompass vector that is a retrovirus, a lentivirus, an adenovirus, an adeno-associated virus, etc.
Pg 2, lines 16-20; pg 10, lines 1-3; pg 25, lines 6-8; pg 28, lines 15-17 teach a single adeno-associated virus (AAV) vector is used to deliver both the RNA agent (e.g., small hairpin RNA or artificial microRNA) and the recombinant RHO. Example 8, pg 36, lines 3-5, describes an AAV encoding the shRNA and RHO. Fig. 12C shows an AAV encoding the shRNA and RHO.
The examples are limited to an AAV vector comprising shRNA (pg 23, lines 25-31) and an AAV vector encoding RHO (pg 24, lines 19-22) sometimes on the same AAV vector (pg 25, lines 6-8; Fig. 12C).
The examples are limited to administering AAV particles in vivo (pg 25, lines 3-13; pg 28, lines 7 & 14).
The specification does not contemplate any vector that is a plasmid that does not encode an AAV vector as broadly encompassed by claims 1 and 32. The specification does not contemplate any vector that is a retrovirus, a lentivirus, an adenovirus, etc. other than an AAV vector as broadly encompassed by claims 1 and 32.
The specification does not correlate administering an AAV particle to a mammal to administering just the AAV vector in the absence of a viral particle as broadly encompassed by claim 32. The specification does not contemplate administering a vector that is a plasmid that does not encode an AAV vector as broadly encompassed by claim 32. The specification does not contemplate administering any vector or viral particles that are a retrovirus, a lentivirus, an adenovirus, etc. other than an AAV vector as broadly encompassed by claim 32.
Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to make/use any vector containing the shRNA and the sequence encoding RHO as required in claim 1 other than an AAV vector or using any vector to treat a mammal that has RP and a mutant RHO gene as required in claim 32 other than an AAV particle.
Response to arguments
Applicants arguments are noted but do not address this aspect of the rejection.
New rejections
The specification does not enable using BHK or Sf9 packaging cells for making AAV viral particles as encompassed by claim 47. Claim 47 is drawn to making AAV particles using HEK293, BHK or Sf9 packaging cells. However, the specification is limited to making AAV particles using HEK293 packaging cells (pg 23, lines 8-9). Sf9 packaging cells are limited to making baculovirus (pg 22, line 9-11). BHK packaging cells are limited to making HSV (pg 22, line 11-13). The specification does not teach making AAV particles in BHK or Sf9 packaging cell lines. Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to use BHK or Sf9 packaging cells for making AAV viral particles as encompassed by claim 47.
The specification does not enable using Sf9 packaging cells to make baculovirus particles as encompassed by claim 49. Claim 49 is drawn to making AAV particles using Sf9 packaging cells and a “baculovirus containing the viral vector”. However, the specification is limited to making AAV particles using HEK293 packaging cells (pg 23, lines 8-9). Sf9 packaging cells are limited to making baculovirus (pg 22, line 9-11). BHK packaging cells are limited to making HSV (pg 22, line 11-13). The specification does not teach making AAV particles in Sf9 packaging cell lines using a baculovirus. Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to use Sf9 packaging cells and a baculovirus for making AAV viral particles as required in claim 49.
Indefiniteness
Claims 45-47, 49 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The phrase “the helper plasmids” [plural] in claim 45 lacks antecedent basis in claim 43 which is limited to “one or more helper plasmid” [singular].
Reference to “the helper cells” in claims 46, 47, 49 should be to ---the packaging cells--- in claim 43.
The art at the time of filing did not reasonably teach or suggest putting a sequence encoding a shRNA comprising the nucleic acids of SEQ ID NO: 7 and 8 together in one vector with a sequence encoding RHO comprising the nucleic acid sequence of SEQ ID NO: 42 as required in claims 1 and 43.
Conclusion
No claim is allowed.
Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638
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