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
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 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.
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1, 4, 8-11, 15, 18-20 and 25-30, in the reply filed on Jun. 4, 2026 is acknowledged. It is noted that claims 5-7 should be included in Invention I.
Claims 1, 4-11, and 18-30 remain pending in the current application, claims 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The requirement for the restriction of Inventions I and II is still deemed proper and is therefore made FINAL.
Claims 1, 4-11, 15, 18-20 and 25-30 have been considered on the merits.
Status of the Claims
Claims 1, 4-11, and 18-30 are currently pending.
Claims 21-24 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 2-3, 12-14, and 16-17 are cancelled.
Claims 1, 4-11, 15, 18-20 and 25-30 have been considered on the merits.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms Lipofectamine® 2000 on pg. 9 line 30; Wallac 1420 Victor3™ plate reader on pg. 59 line 8; Lipofectamine® 3000 on pg. 59 line 10; TRIzol™ Reagent on pg. 59 line 20; RevertAid™ First Strand cDNA Synthesis Kit on pg. 59 line 21; LightCycler® 480 instrument on pg. 59 line 22; and GraphPad Prism® 7.0 software on pg. 60 line 2, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claims 1, 4-11, 15, 18-20 and 25-30 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.
In claim 1, lines 1-4, the phrase “A recombinant adeno-associated virus (rAAV) vector genome that has reduced the generation of double stranded RNA in AAV vector transduction and/or to inhibit an innate immune response that may result from AAC vector transduction”, renders the claim and its dependents indefinite, since it is unclear whether these limitations are meant to be steps that expected to occur, an intended use of the rAAV vector genome, or characteristics of the rAAV vector genome. For the purposes of compact prosecution, the phrase will be interpreted to mean “A recombinant adeno-associated virus (rAAV) vector genome that has reduced generation of double stranded RNA in AAV vector transduction and/or is capable of inhibiting an innate immune response that may result from AAC vector transduction”. In other words that these limitations are being interpreted to refer to characteristics of the rAAV vector genome.
In claim 4, the phrase "wherein the 5' ITR and/or the 3' ITR is modified to diminish or eliminate promoter activity from the 5' ITR and/or the 3' ITR", renders the claim and its dependents indefinite, since it is unclear if these limitations are intended uses or characteristics the rAAV vector genome ITRs must have. In addition, if the phrase is intended to be a functional limitation or characteristic of the ITRs, it is unclear
what structure or feature of the ITR imparts this characteristic. For the purposes of
compact prosecution, in the claims will be interpreted to mean that ITRs
must have diminished or no promoter activity.
In claim 29, the phrase "A recombinant adeno-associated virus (rAAV) vector genome that has reduced generation of double stranded RNA in AAV vector transduction by reducing or preventing transcription initiated by a 3' ITR, wherein an rAAV vector comprising the rAAV vector genome exhibits reduced generation of an innate immune response from host cell transduction", renders the claim and its dependents indefinite, since it is unclear if these limitations are intended uses or characteristics the rAAV vector genome and the rAAV vector containing the rAAV vector genome must have. In addition, if the phrase is intended to be functional limitations or characteristics of the rAAV vector genome and the rAAV vector containing the rAAV vector genome, it is unclear what structure or feature of the rAAV vector genome and the rAAV vector containing the rAAV vector genome imparts this characteristic. For the purposes of compact prosecution, in the claim will be interpreted to mean that rAAV vector genome has reduced generation of double stranded RNA in AAV vector transduction and the rAAV vector containing the rAAV vector genome has reduced generation of an innate immune response that may result from a host cell transduction.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under USC 112 for the reasons set forth above.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (a) written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-11, 15, 18-20 and 25-30 are 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 claims 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to one or more nucleic acid molecules that encode an interfering RNA (RNAi) that targets cytoplasmic dsRNA sensor; and/or a nucleic acid molecule that encodes an inhibitor of MAVS signaling, which have a wide array of activities and/or effects. Thus, the claims are broadly drawn to any RNAi that targets cytoplasmic dsRNA sensor and any nucleic acid molecule that encodes an inhibitor of MAVS signaling. The claims encompass any RNAi that targets cytoplasmic dsRNA sensor and any nucleic acid that inhibits any part of MAVS signaling which are not described by their function, structure or relation thereto. The genus for the inhibitory factor is highly variant, inclusive to numerous structural variants because a significant number of structural differences between genus members is permitted.
For a RNAi that targets cytoplasmic dsRNA sensor, the specification only describes that MDA5 and RIG-I are cytoplasmic viral RNA sensors capable of activating type I interferon signaling pathways (0008 of the published application). In addition, the specification describes siRNA for the dsRNA sensors MDA5, RIG-1 and protein kinase (PKR) (0336 of the published application). The specification does not disclose the diverse genus of RNAi and cytoplasmic dsRNA sensors. The specification does not place any structure, chemical or functional limitations on the embraced by genus “a RNAi that targets cytoplasmic dsRNA sensor”. The specification instead states “examples of an interfering RNA (RNAi) of this invention include small interfering RNA (siRNA), short hairpin RNA (shRNA), microRNA (miRNA), long double stranded RNA (long dsRNA), antisense RNA, ribozymes, etc., as are known in the art, as well as any other interfering RNA or inhibitory RNA now known or later identified” (0072 of the published application). The recitation of “a RNAi that targets cytoplasmic dsRNA sensor” does not convey a common structure or function and is not so defined in the specification. In sum, specification and the claim do not provide any guidance on the structure of the “a RNAi that targets cytoplasmic dsRNA sensor”.
For a nucleic acid molecule that encodes an inhibitor of MAVS signaling, the specification describes that “MAVS signaling can also be inhibited by various molecules from virus infection. For example, a serine protease NS3-4A from hepatitis C virus, the proteases from Hepatitis A virus and GB virus B, and hepatitis B virus (HBY) X protein. During viral infection, some endogenous proteins, such as poly(rC)-binding protein 2, the 20S proteasomal subunit PSMA7, and mitofusin 2, can inhibit MAVS signaling.” (0344 of the published application). In addition, the specification describes specific siRNA sequences for MAVS, SEQ ID NO: 1-4 (0296 of the published application). The specification does not disclose the diverse genus of nucleic acids that encodes an inhibitor of MAVS signaling. The specification does not place any structure, chemical or functional limitations on the embraced by genus “a nucleic acid that encodes an inhibitor of MAVS signaling”. The specification instead states “examples of an inhibitor of MAVS signaling include a serine protease NS3-4A from hepatitis C virus, proteases from Hepatitis A virus and GB virus B, and hepatitis B virus (HBY) X protein, poly(rC)-binding protein 2, the 20S proteasomal subunit PSMA 7, and mitofusin 2, as well as any other inhibitor of MAVS signaling now known or later identified” (0023 of the published application). The recitation of “a nucleic acid that encodes an inhibitor of MAVS signaling” does not convey a common structure or function and is not so defined in the specification. In sum, specification and the claim do not provide any guidance on the structure of the “a nucleic acid that encodes an inhibitor of MAVS signaling”.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all of the potential species of nucleic acid molecules that encode an iRNA that may target a cytoplasmic dsRNA sensor and a nucleic acid molecule that encodes an inhibitor of MAVS signaling. The possible variations of compounds are limitless with potentially thousands of compounds that may exhibit the claimed activities. The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
The specification lacks sufficient variety of species of nucleic acids targeting cytoplasmic dsRNA sensors and the MAV signaling pathway to reflect this variance in the genus since the specification does not provide any examples of such a genus of compounds other than a short list of MAV signaling pathway members and dsRNA sensors. Accordingly, the specification fails to provide adequate written description for the genus of “a RNAi that targets cytoplasmic dsRNA sensor” and “a nucleic acid that encodes an inhibitor of MAVS signaling” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these compounds, the specification does not describe the claimed antagonist in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these extracts at the time of filing of the present application. Thus, the written description requirement has not been satisfied.
Claim 4 is drawn to the rAAV vector genome where the 5’ITR and/or the 3’ITR is modified to diminish or eliminate promoter activity from the 5’ITR and/or the 3’ITR. This limitation is being interpreted as characteristics of the ITRs as explained in the rejection under 35 U.S.C. §112 (b). Thus, the claims are broadly drawn to any ITR that has the function of diminished or no promoter activity. Therefore, the claims encompasses any ITRs which are not described by their structure or relation thereto. The specification only lists this function and does not disclose the structure or feature of the ITRs that impart any of the claimed functions other than that it has been modified (0013, 0067 and 0249 of published application). Additionally, the specification discloses using alternative ITRs known to have no promoter function from a different serotype (0332-0334 of published application). The specification does not disclose the diverse genus or the structures of the ITRs that is responsible for these characteristics or functions.
Claim 29 is drawn to a rAAV vector genome that has reduced generation of double stranded RNA in AAV vector transduction by reducing or preventing transcription initiated by a 3' ITR and an rAAV vector comprising the rAAV vector genome that has reduced generation of an innate immune response in a host cell transduction. This limitation is being interpreted as characteristics of the rAAV as explained in the rejection under 35 U.S.C. §112 (b). Thus, the claims are broadly drawn to any rAAV that has reduced generation of double stranded RNA and reduced generation of an innate immune response in a host cell transduction. Therefore, the claims encompasses any rAAV which are not described by their structure or relation thereto. The specification does not disclose the structure or feature of the rAAV that imparts any of the claimed functions other than suggesting a poly A sequence in the 3’ to 5’ orientation upstream of the 3’ITR and downstream of the NOI, a 5’ and/or 3’ITR with diminished promoter activity, an interfering RNA that targets a cytoplasmic DNA sensor, and a nucleic acid molecule that encodes and in inhibitor of MAVS signaling (0011 and 0013-0015 of published application). Many of these structures as explained above suffer from lack of description. The specification does not disclose the diverse genus or the structures of the rAAV that is responsible for these characteristics or functions.
Claim Rejections - 35 USC § 112 (a) scope of enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-11, 15, 18-20 and 25-30 are 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:
a recombinant adeno-associated virus (rAAV) vector genome that has reduced generation of double stranded RNA (dsRNA) in AAV vector transduction and/or is capable of inhibiting an innate immune response that may result from AAV vector transduction, comprising a AAV 5’ inverted terminal repeat (ITR), a nucleotide sequence of interest (NOI) operably associated with a promoter and an AAV 3’ ITR and further comprising a nucleic acid encoding small interfering (siRNA) for MDA5 and MACS,
does not reasonably provide enablement for any of the one or more poly A (pA) sequences listed in claim 1 A); one or more nucleic acid molecules that encode an interfering RNA (RNAi) that targets cytoplasmic dsRNA as recited in claim 1 B); or all nucleic acid molecules that encode an inhibitor of MAVS signaling as recited in claim 1 C) so that the rAAV vector genome has reduced generation of double stranded RNA (dsRNA) in AAV vector transduction and/or the ability to inhibit an innate immune response that may result from AAV vector transduction. Similarly, the specification does not provide enablement for a recombinant adeno-associated virus (rAAV) vector genome that has reduced generation of double stranded RNA in AAV vector transduction by reducing or preventing transcription initiated by a 3' ITR, wherein an rAAV vector comprising the rAAV vector genome exhibits reduced generation of an innate immune response from host cell transduction as recited in claim 29. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, the enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to (rAAV) vector genome that has reduced generation of double stranded RNA (dsRNA) in AAV vector transduction and/or is capable of inhibiting an innate immune response that may result from AAV vector transduction, comprising a AAV 5’ inverted terminal repeat (ITR), a nucleotide sequence of interest (NOI) operably associated with a promoter and an AAV 3’ ITR and further comprising one of the listed poly A (pA) sequences listed in claim 1 A); one or more nucleic acid molecules that encode an interfering RNA (RNAi) that targets cytoplasmic dsRNA as recited in claim 1 B); and/or a nucleic acid molecule that encodes an inhibitor of MAVS signaling as recited in claim 1 C). Thus, the claims taken together with the specification imply that any of the listed pA sequences, any nucleic acid molecule that encode an interfering RNA (RNAi) that targets cytoplasmic dsRNA and any nucleic acid molecule that encodes an inhibitor of MAVS signaling, results in a rAAV vector with reduced generation of double stranded RNA (dsRNA) in AAV vector transduction and/or the ability to inhibit an innate immune response that may result from AAV vector transduction. Similarly, claim 29 is directed to any recombinant adeno-associated virus (rAAV) vector genome that has reduced generation of double stranded RNA in AAV vector transduction by reducing or preventing transcription initiated by a 3' ITR, and an rAAV vector containing the rAAV vector genome capable of a reduced generation of an innate immune response from host cell transduction when transduced.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The prior art in general teaches that inhibiting an innate immune response to viral vectors is complex. For instance, Pupo et al. (Molecular Therapy, 2022) reports that there are still challenges with AAV vectors including pre-existing humoral immunity to AAV capsid (pg. 3515 Col. 2 para. 5). Pupo states that there still many question regarding rAAV-mediate immune responses (pg. 3532 last para.). Additionally, Pupo reports that the serotype of the ITR can modify gene transfer efficiency and the sequence of the ITR may need to be considered depending on the promoter and target tissue (pg. 3528 Col. 1 para. 2). Pupo further reports that the selection of the polyadenylation signal can affect the transgene expression levels and that short poly(A) signals can have a negative impact on expression levels (pg. 3528 Col. 2 para. 2). In addition, Habjarn et al. (Current Opinion in Virology, 2015) (ref. of record) reports that the natural ligands of cytoplasmic sensors are not well understood (pg. 36 last para.). Habjan further reports that there are numerous cellular pathways that are involved and second messengers that contribute to immunity to viral pathogens and that cell processes are similarly prominent in contributing to virus defense (pg. 36 last para.). Hamilton et al. (Frontiers in Immunology, 2021) also reports on the numerous challenges in overcoming the humoral and cellular immune responses to AAV-based therapies (abstract and Introduction).
Thus, as the state of the art stands, the rAAV vector with the claimed characteristics of reduced generation of dsRNA in AAV vector transduction and/or the ability to inhibit an innate immune response that may result from AAV vector transduction would be unpredictable depending on the such factors but not limited to the specific cell type being transduced, the particular dsDNA sensor, the particular ITRs and poly A tails, and the particular nuclear acid inhibitor of MAVS signaling, and the particular target of MAVS signaling.
(5) The relative skill of those in the art:
The relative skill of those in the art is high.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The instant specification, in Example 1, provides evidence that dsRNA inhibits AAV transduction (0307-0308 of published application), AAV transduction is able to activate dsRNA innate immune response in cells (0309-0310 of published application) and in humanized mice (0318-0319 of published application), transfection with siRNA for MDA5 and MACS increases transgene expression and inhibits IFN- β expression in AAV transduced cells (0320-0321 of published application). In Example 2, the promoter function of the ITRs are hypothesized to cause potential bi-directional transcription and result in forming dsRNA. It is further speculated that by adding pA sequences between the ITRs and the NOI, transcription initiation by the ITRs can be blocked (0331 of published application). Additionally, it speculated that silencing of the dsRNA sensors, MDA5, RIG-I and protein kinase (PKR) will be able to block innate immune response triggered by cytoplasmic dsRNA sensors (0336 of published application). In Example 3, it is demonstrated that the transcripts in a reverse orientation can be generated from AAV transduction (0347-0348 of published application) and that there is an increase in AAV transduction in cells where MAVS is knockdown (0349-0355 of published application).
However, the specification does not provide any guidance for the numerous nucleic acids that encode for RNAi that targets any potential cytoplasmic dsRNA sensor. The specification does not provide any guidance for the numerous nucleic acids that encode an inhibitor for any component of MAVS signaling. The applicants have provided no additional data demonstrating the claimed rAAV vector with the potential nucleic acid sequences recited in A), B) or C) would provide the limitations of a rAAV vector with reduced generation of double stranded RNA (dsRNA) in AAV vector transduction and/or the ability to inhibit an innate immune response that may result from AAV vector transduction. The specification does not provide any guidance for the numerous possible ways a rAAV vector genome can have reduced generation of double stranded RNA by reducing or preventing transcription initiated by a 3’ITR.
Therefore, there is no conclusive evidence in the instant disclosure to indicate that the instantly claimed composition as claimed provides the limitations of a rAAV vector with reduced generation of double stranded RNA (dsRNA) in AAV vector transduction and/or the ability to inhibit an innate immune response that may result from AAV vector transduction.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the claimed invention within the broad scope as instantly claimed.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fitzsimons et al. "Insulators coupled to a minimal bidirectional tet cassette for tight regulation of rAAV-mediated gene transfer in the mammalian brain." Gene Therapy 8.22 (2001): 1675-1681.
Fitzsimons teaches a recombinant adeno-associated virus (rAAV) vector genome (abstract). Fitzsimons teaches the rAAV containing an AAV 5’ inverted terminal repeat (ITR), then a SV40 poly A signal in the 3’ to 5’ direction, then a multiple cloning site for insertion of a nucleotide of interest (NOI) operably linked to a CMV promoter, a second nucleotide operable linked to a second promoter, then a bovine growth factor poly A sequence in the 5’ to 3’ direction, then another AAV 3’ ITR (Fig. 3). Fitzsimons teaches that the inverted terminal repeats significantly increased the level of basal and induced luciferase expression (NOI) and found that inserting insulators between the ITR and NOI provided enhancer blocking activity (pg. 1676 Col. 2 para. 2).
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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