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 .
Preliminary amendment
The preliminary amendments filed on 08/06/2024 has been acknowledged. Claims 1-29 were canceled. New claims 30-48 have been added. Claims 30-48 are pending and considered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 30-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,083, 174 in view of Taubenberger et al. (JAMA, Published Online: May 9, 2007, 297;(18): 2025-2027. doi:10.1001/jama.297.18.2025).
In the instance case, the rejected claims are directed to an immunogenic composition and a method for using the same, wherein the composition is an RNA vaccine molecule, optionally carried by an alphavirus. The RNA composition comprises
(i) a first self-replicating RNA molecule encoding a polypeptide comprising a first antigen; and
(ii) a second self-replicating RNA molecule encoding a polypeptide comprising a second antigen,
wherein the first antigen and the second antigen are both HA from the same subtype of influenza virus, but the first antigen is from a different strain of influenza virus to the second antigen as follows:(a) the first antigen is HA from a pandemic influenza A subtype or an immunogenic fragment or variant thereof, and the second antigen is HA from a different thereof influenza A strain to the first antigen or an immunogenic fragment or variant thereof; or (b) the first antigen is HA from a seasonal influenza A subtype or an immunogenic fragment or variant thereof, and the second antigen is HA from a different seasonal influenza A strain to the first antigen or an immunogenic fragment or variant thereof;
The first antigen is HA from pandemic or seasonal influenza A subtype H1 or H3 or H5 an immunogenic fragment or variant thereof, and the second antigen is HA from a different seasonal influenza A subtype H3 strain to the first antigen or an immunogenic fragment or variant thereof.(Claims 35-36 37 and 47-48)
The claim 31 cites that first antigen and the second antigen are the only antigens from influenza virus in the self-replicating RNA molecules and method of using the same, wherein the self-replicating RNA molecule is made by alphavirus selected from a group consisting of Sindbis (SIN), Venezuelan equine encephalitis (VEE), Semliki Forest virus (SFV), or a combination thereof.
Further the RNA vaccine composition comprises a cationic lipid, a liposome, a microparticle, viral replicon particles (VRPs), an oil-in-water emulsion, or a cationic nano emulsion (Claim 42) . wherein the self-replicating RNA molecules are encapsulated in, bound to, or adsorbed on a cationic lipid, a liposome, a microparticle, viral replicon particles (VRPs), an oil-in-water emulsion or a cationic nano emulsion (Claim 43).
The reference claims are also directed to a An immunogenic composition and a method for using the same, wherein the influenza flu vaccine also comprises (i) a first self-replicating RNA molecule encoding a polypeptide comprising a first antigen and (ii) a second self-replicating RNA molecule encoding a polypeptide comprising a second antigen, wherein the first and second antigens are both from influenza virus, but the first antigen is from a different strain of influenza virus to the second antigen as follows: (a) the first antigen is HA from influenza A subtype H1 or an immunogenic fragment or variant thereof, and the second antigen is HA from a different H1 strain to the first antigen or an immunogenic fragment or variant thereof; or(b) the first antigen is HA from influenza A subtype H3 or an immunogenic fragment or variant thereof, and the second antigen is HA from a different H3 strain to the first antigen or an immunogenic fragment or variant thereof. Further, the first and second antigens are the only antigens from influenza virus in the self-replicating RNA molecules. Or further it is comprising: (iii) a third self-replicating RNA molecule encoding a polypeptide comprising a third antigen, wherein the third antigen is from influenza virus, but is from a different strain of influenza virus to both the first and second antigens. wherein the first, second, and third antigens are the only antigens from influenza virus in the self-replicating RNA molecules. The immunogenic, further comprising: (iv) a fourth self-replicating RNA molecule encoding a polypeptide comprising a fourth antigen, wherein the fourth antigen is from influenza virus, but is from a different strain of influenza virus to the first, second, and third antigens. The immunogenic composition comprises the first and second antigens are HA from influenza A subtype H1 or an immunogenic fragment or variant thereof and the third and fourth antigens are from influenza A subtype H3 or an immunogenic fragment or variant thereof. Still further comprising an adjuvant, still further, wherein the self-replicating RNA molecule is derived from an alphavirus. wherein the alphavirus is selected from the group consisting of: Sindis (SIN), Venezuelan equine encephalitis (VEE), Semliki Forest virus (SFV), and combinations thereof./ A pharmaceutical composition comprising the immunogenic composition of claim 1 and a pharmaceutically acceptable carrier comprising a cationic lipid. F11, While the reference teach that the influx virus used for making the Ran vaccine is the one comprising H1 and H3, They does not explitely teach the using H5. (columns 8-21
Prior to the current Application was filed, the state of art by Taubenberger et al. clearly teach that H5N1 epizootics are unique, however, in causing mortality in wild birds, occasional infections in mammals, severe human infections, and in rare instances possible human-to-human transmission. Given the potential for high morbidity and mortality, an approximation of the risk that H5N1 viruses will adapt to efficient human-to-human transmission would be extremely helpful for pandemic preparedness planning; despite the apparent inevitability of influenza pandemics, data accumulated over the past decade do not necessarily indicate pandemic emergence of H5N1.
Although it is impossible to predict the emergence of a future pandemic other than to strongly suspect that one will eventually occur, or to predict when or where a future pandemic will occur, what subtype it will be, and what degree of morbidity and mortality it will produce. Even though concern over the emergence of an H5N1 pandemic is clearly warranted.
To improve the ability to predict influenza pandemics, it is necessary to increase knowledge of the basic biology and ecology underlying host-switching events. The genetic changes that are needed to convert an influenza virus from one that has adapted to the enteric tract of wild waterfowl into a respiratory virus of horses, pigs, or humans are not fully understood. Enhanced surveillance and prospective study at the human-animal interface are crucial for understanding viral movement and evolution in an extraordinarily complex ecosystem. The H5N1 panzootic is a potent reminder of the constant and constantly changing risk posed by influenza A viruses. It is unknown whether H5N1 viruses will be able to adapt to humans and cause efficient person-to-person transmission; however, preparation for future influenza pandemics caused by H5N1 and any number of other viral possibilities is important.
Therefore, in view of the teaching by the expertise Dr. Toabenberger et al. it would have been obviously including H5N1 pandemic one of the clearly warranted into the influenza RNA vaccine preparation in order to protect a potential influenza pandemic caused by H5N1 in addition to the H1 and H3 pandemic strains with highly expected success because making HA antigen RNA molecule encoding the HA antigen is well known in in the state of art absence of any unpredictable result.
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.
(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 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 30-31, 35-36 and 37-48 are rejected under 35 U.S.C. 102(a) (2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US Patent No. 10022436B2 by Henderson for claims 32-34
Henderson presents an invention related to a self-replicating RNA molecules that encodes RNA molecule of viral antigen including more than one influenza HA antigen. For instance, it teaches that In some embodiments, the antigen encoded by a recombinant alphavirus replicon of the disclosure is an influenza virus hemagglutinin (HA) protein. In some embodiments, the antigen encoded by a recombinant alphavirus replicon of the disclosure is an influenza virus neuraminidase (NA) protein. In some embodiments, HA is derived from a viral strain of an influenza A, B, or C virus. In some embodiments, the antigen is derived from a viral strain of influenza A virus and comprises one or more HA subtypes including H1, H2, H3, H4, H5, H7, H8, H9, H10, H11, H12, H13, H14, H15, H16, H17, or HA18. In some embodiments, multiple replicons each encoding a different HA are used, such that an immunogenic response to more than one HA is elicited. In some embodiments, a single replicon encoding multiple different HA polypeptides are used, such that an immunogenic response to more than one HA is elicited. In some embodiments, the replicon composition is monovalent (the vaccine protects against one influenza strain, such as one HA subtype antigen, e.g., H1), bivalent (the vaccine protects against two influenza strains, such as two HA subtype antigens, e.g., H1 and H3), trivalent (the vaccine protects against three influenza strains, such three HA subtype antigens, e.g., H1, H3, and a circulating influenza B strain); quadrivalent (the vaccine protects against four influenza strains, such as four HA subtype antigens, e.g., H1, H3, influenza B Yamagata, and influenza B Victoria); or still higher valencies. In some embodiments, the HA antigens are determined based on the dominant influenza strains (or the predicted most dominant strains) causing pathogenesis in any particular season. In some embodiments, the microneedle composition is bivalent and comprises alphavirus replicons that encode an HA polypeptide from a viral strain of an influenza A H1 virus; and an HA polypeptide from a viral strain of an influenza A H3 virus. In some embodiments, the bivalent HA polypeptides are encoded in the same alphavirus replicon. In some embodiments, the bivalent HA polypeptides are encoded on separate alphavirus replicons. In some embodiments, the microneedle composition is trivalent and comprises alphavirus replicons that encode an HA polypeptide from a viral strain of an influenza A H1 virus; an HA polypeptide from a viral strain of an influenza A H3 virus; and an HA polypeptide from a viral strain of a circulating influenza B virus. In some embodiments, the trivalent HA polypeptides are encoded in the same alphavirus replicon. In some embodiments, the trivalent HA polypeptides are encoded on separate alphavirus replicons. In some embodiments, the microneedle composition is quadrivalent and comprises alphavirus replicons that encode an HA polypeptide from a viral strain of an influenza A H1 virus; an HA polypeptide from a viral strain of an influenza A H3 virus; an HA polypeptide from a viral strain of an influenza B Yamagata lineage virus; and an HA polypeptide from a viral strain of an influenza B Victoria lineage virus. In some embodiments, the quadrivalent HA polypeptides are encoded in the same alphavirus replicon. In some embodiments, the quadrivalent HA polypeptides are encoded on separate alphavirus replicons. In some embodiments, the HA subtype chosen for the immunogenic composition is dictated by the most dominant influenza strain(s) (or influenza strain(s) predicted to be the most dominant) during any given season. In some embodiments, the replicon encoding the HA antigen generates an immune response (especially an antibody response), to the influenza virus antigen in a subject when delivered to the subject. (Paragraph Columns 1-2, 54, 55-56)
In some embodiments, the 5′ nucleotide of a replicon has a 5′ triphosphate group. In some embodiments, in a capped RNA, the 5′ triphosphate group is linked to a 7-methylguanosine via a 5′-to-5′ bridge. In some embodiments, a 5′ triphosphate enhances RIG-I binding and thus promotes adjuvant effects. In some embodiments, a replicon comprises a 3′ poly-A tail. In some embodiments, the replicon includes a poly-A polymerase recognition sequence (e.g., AAUAAA) near its 3′ end. In some embodiments, a replicon for delivery to a subject is single-stranded. In some embodiments, single-stranded RNAs initiate an adjuvant effect by binding to TLR7, TLR8, RNA helicases, and/or PKR. In some embodiments, RNA is delivered in double-stranded form (dsRNA) and binds to TLR3. In some embodiments, TLR3 is triggered by dsRNA which is formed either during replication of a single-stranded RNA or within the secondary structure of a single-stranded RNA. In some embodiments, a replicon comprises (in addition to any 5′ cap structure) one or more nucleotides having a modified nucleobase.
In some embodiment also teaches that the self-replication RNA replicon is also made as a Dendrimers and Dendrimer Nanoparticles
In some embodiments, the dendrimer or surface reactive groups of the dendrimer are modified, which also includes cationic moiety modified dendrimers (e.g. oligoarnine, tertiary amine, quaternary ammonium, imidazolium, guanidium, or phosphonium modified dendrimers. (See column 27-39)
In some embodiments, the one or more bioactive agents (e.g., polypeptides or recombinant alphavirus replicons) are encapsulated in a liposome or just lipids.
In some embodiments, the hydrophilic portion of a lipid is modified by attachment (e.g., covalent attachment) of a polyethylene glycol (also referred to as PEGylation). In some embodiments, PEGylation increases stability and prevent non-specific adsorption of the liposomes. In some embodiments, lipids are conjugated to PEG using any suitable technique.
For the alphaviruses (e.g., VEE, sindbis, or SFV), and the like. Is also be selected for making alphavirus self-replication replicon.(Claims 38-40).
The cited reference also teaches that the self-replication RNA replicon can be formulated with a pharmaceutical excipients (Column 43-44). 1-2,
Therefore, the cited reference teaches limitation explicitly claims 30-31 and 35-48.
Or alternatively for clams 32-34, while the cited reference does not explicitly teaches the third or fourth or alternatively for a person ordinarily skilled in the art will be motivated using the self -replication module to make the third or fourth influence HA expression replicon virus and combined then together to induce an immune response with a readable expectation of success.
Conclusion
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671
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