DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Applicant’s amendments to the claims and arguments filed on February 20, 2026 have been received and entered. Claims 1, 45-48 have been amended, while claims 2-6, 8, 10, 12-24, 26-28, 30-35, 37, 39- 44 have been canceled. Claims 50 and 51 are newly added. Claims 1, 7, 9, 11, 25, 29, 36, 38, 45-50 and 51 are pending in the instant application.
Claims 1, 7, 9, 11, 25, 29, 36, 38, 45-50 and 51 are under consideration.
Withdrawn-Claim Rejections - 35 USC § 103
Claims 1, 24 and 43 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lo (WO/2000/69913, dated 11/23/2000)/Gillies et al (WO/2006/000448, dated 01/05/2006), Blumberg et al (US7547436, dated 06/16/2009), Tavernier et al (Journal of Controlled Release, 2011, 150, 238-247) and Guild et al (WO/2011/068810, dated 06/09/2011) as applied above for claim 1 and 40, and, Kariko et al (US20090286852, IDS). Applicants’ cancellation of claims 24 and 43 renders their rejections moot.
Withdrawn-Claim Rejections - 35 USC § 112-Scope of enablement
Claims 40-41, and 43 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, because the specification fails to provide an enablement for the full scope of the claimed invention. Applicants’ cancellation of claims 40-41, and 43 renders their rejections moot.
Maintained & New -Claim Rejections - 35 USC § 103-in modified from
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 7, 9, 11, 25, 29, 36, 45-49 and 51 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lo (WO/2000/69913, dated 11/23/2000)/Gillies et al (WO/2006/000448, dated 01/05/2006), Blumberg et al (US7547436, dated 06/16/2009), Tavernier et al (Journal of Controlled Release, 2011, 150, 238-247) and Guild et al (WO/2011/068810, dated 06/09/2011).
Regarding claim 1, Lo teaches a composition comprising a nucleic acid encoding a fusion comprising an immunoglobulin Fc region; and a target protein sequence comprising interferon-alpha (see claim 1 and 24 of ‘913), wherein the nucleic acid may be RNA (abstract, page 2, lines 29, page 3, lines 7, page 5, line 19). It is further disclosed that nucleic acid sequences encoding the interferon-alpha containing fusion protein can be combined with a pharmaceutically acceptable (see page 3, lines 4-5). Likewise, Gillies teaches a composition comprising a nucleic acid encoding a fusion comprising a signal sequence and an immunoglobulin Fc region linked by peptide bond with an interferon-β protein (see claim 15 and 20 of ‘448, page 25, lines 14-21, page 26, lines 23-26), wherein the nucleic acid may be DNA or RNA (page 11, line 5, page 28, line 29-30). It is further disclosed that nucleic acid sequences encoding the interferon-alpha containing fusion protein can be combined with a pharmaceutically acceptable carrier (see page 29, line 27, page 30, line 3). Gillies teaches that the immunoglobulin Fc region can include an immunoglobulin hinge region and an immunoglobulin heavy chain constant region. In one embodiment, the Fc region is derived from IgGl (see page 3, lines 28-32, page 4, lines 17, 25, page 21, claims 1 and 6-7) (limitation of claims 2 and 4). Blumberg provide evidence of delivering a fusion protein comprising the FcRn binding partner protein conjugate with cytokines or erythropoietin (EPO). It is further disclosed that the composition may be delivered via aerosol delivery to the pulmonary epithelium via intranasal delivery to the nasal epithelium (col. 4, lines 16-22, lines 10-12, col. 15, lines 54-) (limitation of claim 48). Blumberg teaches that the active ingredient can be conveniently delivered in the form of an aerosol spray presentation from pressurized packs or a nebulizer (see col. 15, lines 49-54). It is further disclosed that the FcRn binding partner conjugates are designed to deliver a wide variety of therapeutics including RNA nucleotides (see col. 6, lines 3).
Regarding claim 51, Blumberg teaches “FcRn binding partners", such as IgG or an FcRn binding portion thereof can be used to deliver an antigen or a therapeutic across an epithelial systemic circulation thereby eliciting a beneficial effect (see col. 5, lines 36-41, claim 1 of ‘436).
Lo/Gillies differs from claimed invention by not explicitly disclosing (i) composition is mRNA encoding fusion comprising an immunoglobulin Fc region and a target protein sequence and (ii) limitation of claim 7, 9 and 11, .
Prior to instant invention, Tavernier et al provide explicit motivation to use mRNA‐mediated transfection with major advantages over the use of pDNA (abstract). It is disclosed that the advantages include mRNA does not need to cross the nuclear barrier to exert its biological activity and in addition lacks CpG motifs (limitation of claim 16), which reduces its immunogenicity. Secondly, it provides insight as to how mRNA can be modified to increase its half‐life and in the necessities of exogenously produced mRNA to be successfully used in transfection protocols (abstract, see page 239, col. 1 to col. 2). Tavernier et al disclose different techniques of mRNA delivery (see page 241, col. 2). Tavernier et al disclose that the 5′ ends of mRNA are modified post-transcriptionally in the nucleus with a methylated m7GpppN cap structure (see page 240, col. 2, para. 2). Tavernier differs from claimed invention by not explicitly disclosing the limitation of claim 7, 9, 11.
Guild et al cure the deficiency by teaching a method a expressing a protein in subject, wherein the subject has a protein deficiency, comprising, said method comprising administering a composition comprising an mRNA and a transfer vehicle, wherein the mRNA encodes a functional protein, and wherein the mRNA comprises a modification, wherein the modification confers stability to the administered mRNA (see claim 63 of ‘810), wherein following expression of said mRNA by a target cell a functional protein is produced. Guild provide motivation to formulate nucleic acid (mRNA) composition in a lipid or liposomal transfer vehicle to facilitate delivery to the target cells and/or stabilize the nucleic acid contained therein (see page 4, lines 21-23)
With respect to claim 7, Guild et al teach that the mRNA molecule comprises a 5' untranslated region (see claim 68 of ‘810), wherein the 5' untranslated region is from CMV IEl (see claim 69 of 810).
Regarding claim 9, Guild et al teach the method, wherein the mRNA molecule comprises a Cap 1 structure (see claim 72 of ‘810).
With respect to claim 11, It is further disclosed that the mRNA molecule comprises a 3' untranslated region (see claim 73 of ‘810), wherein the 3' untranslated region is from hGH (see claim 75 of ‘810).
Regarding claims 1, 49, Guild et al teach that mRNA molecule comprises one or more modified nucleosides that includes pseudouridine to enhance stability and translational capacity, as well as diminishing immunogenicity in vivo (page 13, lines 14-16).
With respect to claim 17, Guild teaches the composition comprises, wherein the mRNA encodes a protein that is deficient in an individual (see claim 63 of ‘810) particularly in the management and treatment of a large number of diseases, in particular diseases which result from protein and/or enzyme deficiencies (see page 3, liens 1-5).
With respect to claim 25, Guild teaches that the transfer vehicle includes PEI (see page 19, line 5).
With respect to claim 1, 40, Guild teaches a mRNA composition, wherein the lipid nanoparticle comprises one or more non- cationic lipids (see claim 78 ‘810), wherein the lipid nanoparticle comprises one or more PEG- modified lipids (see claim 79 of 810), wherein the lipid nanoparticle comprises a cholesterol (see claim 80 of ‘810).
Regarding claim 29 and 36, Guild teaches that the transfer vehicle is a lipid nanoparticle (see claim 83, 810), wherein transfer vehicle comprises a mixture of the lipids CHOL, DOPE, DLinDMA and DMG-PEG-2000 (see page 4, lines 24-26, and claim 26 of‘810).
With respect to claim 47. Guild teaches that the polypeptide (IFN-beta) is secreted by the cell (see example 3).
Therefore, it would have been prima facie obvious for a person of ordinary skill to combine the teachings of prior art to combine the teachings of prior art to modify the composition comprising a nucleic acid encoding a fusion comprising an immunoglobulin Fc region; and a target protein sequence comprising interferon-alpha by using FcRn a, to induce expression of a functional polypeptide in a subject, wherein the nucleic acid is a RNA, as disclosed in Lo/ Gillies by using a mRNA composition in transfer vehicle as disclosed in Guild in a method for inducing the expression of functional polypeptide, as instantly claimed, with a reasonable expectation of success, at the time of the instant invention. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so because prior art explicitly provide motivation to substitute a plasmid DNA composition with mRNA-based delivery composition to express functional polypeptide because art teaches (i) use of conjugate of an FcRn binding partner and the interferon (therapeutic protein) facilitates optimal delivery of interferon across an epithelial barrier (Blumberg), (ii) mRNA does not need to cross the nuclear barrier to exert its biological activity and (iii) it lacks CpG motifs that reduces its immunogenicity (supra). Further, one of ordinary skill in the art would be further motivated to formulate the nucleic acid (mRNA) composition in a lipid or liposomal transfer vehicle in order to facilitate delivery of the composition to the target cells and/or stabilize the nucleic acid contained therein as reported by Guild. One of skill in the art would have been expected to have a reasonable expectation of success in using modified mRNA‐mediated composition formulated in transfer vehicle for transfection as compared to use of pDNA because prior art successfully reported (i) mRNA‐mediated transfection to express functional polypeptide and (ii) modifying mRNA molecule formulated in transfer vehicle provided stability to express functional polypeptide in target cells (see Tavernier and Guild). It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 1, 50 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lo (WO/2000/69913, dated 11/23/2000)/Gillies et al (WO/2006/000448, dated 01/05/2006), Blumberg et al (US7547436, dated 06/16/2009), Tavernier et al (Journal of Controlled Release, 2011, 150, 238-247) and Guild et al (WO/2011/068810, dated 06/09/2011) as applied above for claim 1 and 40, and, Kariko et al (US20090286852, IDS).
The teaching of Lo/Gillies, Blumberg, Tavernier and Guild have been described above and relied in same manner here. The combination of references differs from claimed invention by not explicitly disclosing that the) the composition formulated for lung epithelium.
Kariko teaches administration to the lung by intratracheal aerosolization (para 0246) and via an inhaler that delivers RNA. The mRNA is formulated and delivered and expressed in the lung epithelium (see figure 14, example 23 ). Kariko further teaches mRNA composition that is formulated for the delivery of the composition via the respiratory tract behaves similar to intravenously administered mRNA (see example 15).
Therefore, it would have been prima facie obvious for a person of ordinary skill to combine the teachings of prior art to modify the composition comprising a mRNA encoding a fusion comprising an immunoglobulin Fc region; and a target protein sequence comprising interferon-alpha by using FcRn as disclosed in Blumberg to formulated for the lung epithelium delivery as suggested in Kariko, to induce expression of a functional polypeptide in the lung epithelium, as instantly claimed, with a reasonable expectation of success, at the time of the instant invention. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do SO because art teaches mRNA composition that is formulated for the delivery of the composition via the respiratory tract behaves similar to intravenously administered mRNA\ (see Kariko). One of skill in the art would have been expected to have a reasonable expectation of success because prior art successfully reported delivery of mRNA to pulmonary epithelium (above). It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: ww.uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 1, 38, and 47 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lo (WO/2000/69913, dated 11/23/2000)/Gillies et al (WO/2006/000448, dated 01/05/2006), Blumberg et al (US7547436, dated 06/16/2009), Tavernier et al (Journal of Controlled Release, 2011, 150, 238-247) and Guild et al (WO/2011/068810, dated 06/09/2011) as applied above for claim 1, and Guild (2, WO2012/170930, dated 12/13/12, EFD6/8/2011)/or Mutzke (WO2011069587, dated 6/16/2011).
The teaching of Lo/Gillies, Blumberg, Tavernier and Guild have been described above and relied in same manner here. The combination of reference differs from claimed invention by not explicitly disclosing wherein said composition is lyophilized.
The deficiency is cured by Guild (2) who reported a composition comprising mRNA encoding an enzyme which is abnormally deficient in an individual with a lysosomal storage disorder and a transfer vehicle comprising lipid nanoparticle, wherein said composition is lyophilized or said composition is a reconstituted lyophilized composition (see claims 1-2, 17-18 of ‘930), wherein the polypeptide is h alpha-galactosidase (GLA) protein (a lysosomal protein (page 44). Likewise, Mutzke emphasizes the lyophilization of nucleic acids including mRNA encoding therapeutic protein composition that is particularly suitable for enhancing and improving storage and shipping capabilities of nucleic acids for multiple purpose (abstract, page 7, lines 22, page 10, line 17, page 11, line 20, page 12, lines 10-30, claims 1, 8 of ‘587).
Therefore, it would have been prima facie obvious for a person of ordinary skill to combine the teachings of prior art to modify the composition comprising a mRNA encoding a fusion as disclosed in Lo/Gillies, Blumberg in view of Guild by lyophilizing the composition as suggested in Guild(2)/ Mutzke , as instantly claimed, for enhancing and improving storage and shipping capabilities of the nucleic acids composition, with a reasonable expectation of success, at the time of the instant invention. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so in order to improve the storage and shipping capabilities of nucleic acids for multiple purpose (see above). One of skill in the art would have been expected to have a reasonable expectation of success because prior art successfully reported lyophilizing and reconstituting lyophilized mRNA compositions. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 1 and 9 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lo(WO/2000/69913, dated 11/23/2000)/Gillies et al (WO/2006/000448, dated 01/05/2006), Blumberg et al (US7547436, dated 06/16/2009), Tavernier et al (Journal of Controlled Release, 2011, 150, 238-247) and Guild et al (WO/2011/068810, dated 06/09/2011) as applied above and further in view of Labourier et al (US Patent application no 20050287539, dated 12/29/2005).
The teaching of Lo/Gillies, Blumberg, Tavernier and Guild have been described above and relied in same manner here. The combination of references teaches a composition comprising (a) at least one mRNA molecule, at least a portion of which encodes a therapeutic polypeptide fused to a polypeptide capable of binding to an Fc receptor; and (b) a transfer vehicle. However, combination of reference differs from claimed invention by not explicitly disclosing that the (i) wherein the mRNA comprises m7GpppG cap.
However, prior to instant invention, Labourier et al teach cap analog refers to a non-extendible di-nucleotide that has cap functionality and facilitates translation or localization, and/or prevents degradation of the transcript, when incorporated at the 5' end of a transcript, typically having an m7GpppG or m7GpppA structure (see para. 22).
Therefore, it would have been prima facie obvious for a person of ordinary skill to combine the teachings of prior art to modify the composition comprising a mRNA encoding a fusion comprising an immunoglobulin Fc region as disclosed in Lo/Gillies, Blumberg to modify the mRNA comprises 5' cap as suggested by Labourier, to induce expression of a functional polypeptide in a subject, as instantly claimed, with a reasonable expectation of success, at the time of the instant invention. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of skill in the art would have been expected to have a reasonable expectation of success because prior art successfully reported mRNAs that included a 5' cap structure including m7GpppG. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Response to arguments
Applicant disagree with the rejection arguing none of the cited references either alone or in combination teach or suggest the claimed invention. Applicant argues that prior art of Lo/Gillies disclose plasmid DNA encoding Fc-fusion protein, however, neither reference specifically disclose mRNA encoding such protein. Applicant state that mRNA therapy was deemed to be highly unpredictable because of its instability and immunogenicity (exhibit A, Ni et al 2002). Applicant conclude that a person of skill in the art would not have had any reasonable expectation of success in arriving at the claimed inventions directed to mRNA based on references disclosing DNA. Applicants’ arguments have been fully considered, but are not found persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicants in part rely on the selective reading of the teachings of Lo /Gillies. to formulate the grounds for teaching away. In the instant case, applicant in part agree that Lo /Gillies teaches DNA encoding Fc-fusion protein. However, both Lo /Gillies contemplated nucleic acid encoding Fc-fusion protein may be DNA or RNA. In this context, it is Tavernier who explicitly provide motivation of using mRNA as compared to plasmid DNA as (1) it is safer than pDNA and does not integrate into the genome of the transfected cell, (ii) do not require extraneous promoter and (iii) devoid of immunogenic CpG motifs (see page 239, col. 1, para. 2-3). Guild et al cure the deficiency by teaching inducing expression of a protein in subject using a composition comprising a mRNA and a transfer vehicle, wherein the mRNA encodes a functional protein, and wherein the mRNA comprises a modification, wherein the modification confers stability to the administered mRNA (see claim 63 of '810), wherein following expression of said mRNA by a target cell a functional protein is produced, wherein said administration results in extended or prolonged activity of the compositions comprising mRNA encoding functional protein or enzyme (see page 11, lines 15- 25). It is further disclosed that liposome, encapsulate the nucleic acid without compromising biological activity (see page 18, lines 8-9, page 20, lines 20-21, page 25, lines 25-30). Thus, Guild et al cure the deficiency in Lo/Gillies by successfully reporting inducing prolonged expression of mRNA encoding protein within transfer vehicle. Therefore, the fact that mRNA encoding protein may be administered to express protein to a greater extent is an expected result that is safer than use of pDNA, and is the goal behind using mRNA encoding protein.
In response to applicant’s argument that none of the references teach mRNA encoding fusion protein via pulmonary delivery, it is noted that Blumberg provide explicit guidance that compositions containing therapeutics conjugated to a FcRn binding partner could be delivered to intestinal epithelium (abstract). It is further disclosed that "FcRn binding partners", such as IgG or an FcRn binding portion thereof is used to deliver a therapeutic across an epithelial systemic circulation thereby eliciting a beneficial effect (see col. 5, lines 35-41). As stated above, one of ordinary skill in the art motivated to substitute a plasmid DNA composition with mRNA-based delivery composition to express functional polypeptide because art reported (i) use of conjugate of an FcRn binding partner and the interferon (therapeutic protein) facilitates optimal delivery of interferon across an epithelial barrier in to systemic circulation (Blumberg), (ii) mRNA does not need to cross the nuclear barrier to exert its biological activity and (iii) it lacks CpG motifs that reduces its immunogenicity (supra). Further, one of ordinary skill in the art would be further motivated to formulate the nucleic acid (mRNA) composition in a lipid or liposomal transfer vehicle in order to facilitate delivery of the composition to the target cells and/or stabilize the nucleic acid contained therein as reported by Guild. One of skill in the art would have been expected to have a reasonable expectation of success in using modified mRNA‐mediated composition formulated in transfer vehicle for transfection as compared to use of pDNA because prior art successfully reported (i) mRNA‐mediated transfection to express functional polypeptide and (ii) modifying mRNA molecule formulated in transfer vehicle provided stability to express functional polypeptide in target cells (see Tavernier and Guild).
In response to applicant’s argument that mRNA therapy is highly unpredictable, it should be noted that none of the pending claims require any mRNA therapy or any expression in any target cell and/or tissue. Therefore, applicant’s reliance of Ni (2002) showing mRNA are highly immunogenic in human DC is not relevant to claimed composition that is not limited to any mRNA therapy. Further, Applicant should note that obviousness does not require absolute predictability of success; for obviousness under 35 U.S.C. § 103, all that is required is a reasonable expectation of success. See In re O'Farrell, 7 USPQ2d 1673 (CAFC 1988). To the extent that Guild et al. describe the inducing expression of protein by administering mRNA encoding protein and transfer vehicle, the rejection is applicable to the instant case. Applicants' selective reading of Lo/Gillies ignores the teachings of the reference of Guild et al. There is no requirement for Lo/Gillies to teach that which is clearly taught by Guild et al. Absent evidence of any unexpected superior result or any other secondary consideration, a person of skill in the art would be motivated to combine the teachings of prior art to modify the composition of Lo/Gillies for an aerosol delivery to the pulmonary epithelium to a subject a composition comprising a mRNA encoding a fusion comprising an immunoglobulin Fc region; and a target protein sequence using the concept of delivering modified mRNA that is encapsulated within transfer vehicle as disclosed in Guild and Blumberg/Kariko with a reasonable expectation of success.
On pages 7-9 of the applicant's arguments, applicant re-iterates and relies on their previous arguments that have been discussed in preceding section. The arguments are substantially the same as those addressed in the foregoing response.
As stated in previous office action, performance of mRNAs varied significantly with delivery vehicle, there were several consistencies. For example, two of the modified mRNAs – m5C/s2U (25% substitution) and m5U – did not improve protein expression when incorporated into any of the four delivery vehicles. This confirms that there are many important factors in mRNA design, and that incorporations of base modifications known to decrease immune stimulation does not guarantee improved translation. The m5C/s2U modification had no impact on total expression when incorporated into C12–200 and 200Oi10 nanoparticles, and it decreased expression for cKK-E12 and ZA3-Ep10. The m5U modification was always detrimental to efficacy, inducing up to 90% reductions in total Luc expression (see Melamed et al Journal of Controlled Release 341 (2022) 206–214, art of record page 210, col. 1, para. 3, previously cited as evidence).
In the instant case, there is no evidence that a generic composition comprising at least one mRNA molecule and a nanoparticle would exhibit unexpected results similar to one demonstrated by a very specific formulation disclosed in post filing art A to C (previously made of record).
Therefore, in view of the fact patterns of the instant case, and the ground of rejection outlined by the examiner, applicants' arguments are not compelling and do not overcome the rejection of record.
Examiner’s note:
A telephone call was made to applicant’s representative on April 15, 2026 to discuss allowable subject matter. It was indicated that WO2012/170930 teaches the specific composition of lipid nanoparticle that is disclosed in formulation 1 to 6 of instant application and therefore a declaration to obviate the reference of record would be required. No agreement was reached.
Should applicant provide evidence that WO2012/170930 is not by others and not available as prior art and amend the claim to recite a specific composition that provide evidence of unexpected and/or superior results , instant obviousness rejection may be overcome pending further consideration. Representative claim for consideration:
A composition comprising
(a) at least one mRNA molecule, at least a portion of which encodes a fusion protein comprising a signal sequence and a polypeptide fused to a FcRn binding peptide or IgG immunoglobulin Fc domain capable of binding to a neonatal Fc receptor, wherein the mRNA molecule comprises a 5' cap structure, a 5' untranslated region and 3' untranslated region; and
(b) a transfer vehicle, wherein the transfer vehicle is a lipid nanoparticle comprising (i) C12-200, DOPE, CHOL, and DMG-PEG-2000 at a molar ratio of 40:30:25:5, (ii) DODAP, DOPE, cholesterol, DMG-PEG2K at a molar ratio of 18:56:20:6, (iii) HGT4003, DOPE, cholesterol and DMG-PEG2K at a molar ratio of 50:25:20:5, (iv) HGT5000, DOPE, cholesterol and DMG-PEG2K at a molar ratio of 40:20:35:5 or (v) HGT5001, DOPE, cholesterol and DMG-PEG2K at a molar ratio of 40:20:35:5,
wherein the at least one mRNA molecule comprises one or more modified nucleosides and is encapsulated within the lipid nanoparticle,
wherein the composition is formulated for pulmonary delivery, and wherein delivery of the composition results in systemic circulation in a subject administered the composition
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANOOP K. SINGH whose telephone number is (571)272-3306. The examiner can normally be reached Monday-Friday, 8AM-5PM.
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/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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