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 .
Priority
This application is a national stage entry under 35 USC 371 of PCT/US2021/032601 (filed on 5/14/2021). Acknowledgement is made of Applicant’s claim for benefit to US Provisional applications 63/030,3739 (filed on 5/27/2020) and 63/025,936 (filed on 5/15/2020).
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/19/2025 is acknowledged.
Claims 46 and 51 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/19/2025.
Claims Status
Claims 3,5,16-18,20,23,26-27,39,43,46,51 and 56-62 are pending.
Claims 46 and 51 are withdrawn from consideration based on restriction election.
Claims 3,5,16-18,20,23,26-27,39,43, and 56-62 have been considered on the merits.
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 3,5,16-18,20, 23,26-27,39,43, and 56-62 are rejected under 35 U.S.C. 103 as being unpatentable over Brader et al (WO 2018/089540 A1; as cited in IDS filed on 5/11/2023) and in view of Eygeris et al (Nano Letters, 5/6/2020), evidenced by “Moderna’s Work on a Potential Vaccine Against COVID-19” (dated 3/16/2020; https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19), and GenBank OK120841.1.
Brader et al discloses a lipid nanoparticle (LNP) formulation, such that the LNP include therapeutics such as RNA and delivered to regulate polypeptide, protein or gene expression. They also disclose manufacturing LNP formulations (See, Abstract).
Regarding claim 3, 5, and 16: Brader et al teaches a stabilized LNP formulation comprising of a plurality of LNPs and a stabilizing agent that mitigates the degradation of LNPs or subpopulation. The LNP formulation (either liquid or lyophilized) that is stored at about 4 °C or higher (See, ¶00139). Brader et al teaches that a pharmaceutical composition in accordance with the present disclosure may be prepared, packaged, and or sold in bulk as a single unit dose, and or as a plurality of single unit doses (See, ¶00467). Brader et al teaches that storage refers to storing the disclosed LNP formulation product either in its final state or in-process state before final packing and the modes of storage include vials and syringes (See, ¶00140).
Therefore, Brader et al teaches a liquid pharmaceutical composition comprising RNA formulated in an LPN. The liquid is necessarily provided in a vial or container, the vial or container reads on an article that contains the formulation.
Brader et al teaches that one embodiment, the formulation is stable at temperatures from about 2°C to 8°C for at least 2 months (See, ¶00159). Brader et al further teaches that there is a particular embodiment where the formulation disclosed is stabilized at a temperature ranging between -20°C and 4°C at a nucleic concentration (e.g. an mRNA concentration) of up to 2 mg/mL for at least 12 weeks (See, ¶00161).
Therefore, Brader et al teaches an article…wherein the article has a shelf-life of at least three months when stored at greater than 0°C and less than or equal to 10°C.
Brader et al teaches that the amount of therapeutic (e.g. RNA, mRNA) in a LNP may depend on the size, composition, desired target and or application of the LNP, as well as the properties of the therapeutic. They further teach that amount of RNA useful in a LNP may depend on size, sequence, and other characteristics of the RNA and relative amounts of the therapeutic, along with other elements in the LNP may vary (See, ¶00450). It is also taught that a unit dose is discrete amount of the pharmaceutical compositions comprising a predetermined amount of the LNP (active ingredient) and the it is equal to the dosage of the active ingredient which would be administered to a subject and or a convenient fraction of such as dosage such as, one half or one third of such a dosage (See, ¶00467).
Brader et al differs from the claims in 2 aspects (1) the limitation wherein the article comprises a total amount of RNA and the equation associated with this limitation in claim 3 and 5, and (2) the limitation where the RNA in the formulation encodes for an infectious disease antigen and the disease is SARS-CoV-2.
However, each of these differences are considered prima facie obvious, as follows:
Regarding (1) the limitation about the total amount of RNA and the equation found in claims 3, the claims are requiring a product with X amount of RNA based on the equation in the claim. Brader et al renders this obvious because it teaches a formulation with to 2 mg/mL in a vial stored (See, ¶00161). One of ordinary skill of the art can work backwards to fill in the equation such that the values are less than or equal to 2mg/mL depending on the dose of individual full length RNA. Brader et al also provides motivation to optimize the RNA content in the invention. Therefore, it would have been obvious to formulate the product in the article to account for dosage, number of doses and degradation to achieve an amount to be in an article of LNP with RNA.
Regarding (2) the limitation where the RNA in the formulation encodes for an infectious disease antigen and the disease is SARS-CoV-2, Eygeris et al teaches LNP packaged mRNA vaccines have been deployed against infectious diseases such as COVID-19 (See, Abstract). Eygeris et al teaches that the first potential mRNA vaccine against SARS-CoV-19 (SARS-CoV-2) was administered just 63 days after the identification of the virus sequence (See, p4543 ¶1). Eygeris et al cite to Moderna’s website (accessed on 3/17/2020). Moderna’s website discloses that the mRNA vaccine is mRNA -1273. The mRNA-1273 is 3828 nucleotide sequence against the spike protein of SARS-CoV-2 (See GenBank OK120841.1). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the RNA in Brader et al in the context of LNP formulation in the article with mRNA-1273 used in vaccines for SARS-CoV-2, taught by Eygeris et al for a similar purpose. Both Brader et al and Eygeris et al teach mRNA in LNPs.
The use of mRNA-1273 encoding for SARS-CoV-2 in place of the non-specific RNA in Brader et al, is a predictable use of prior art elements according to their established functions, leading to the predictable result of an LNP formulation where the RNA encodes for SARS-CoV-2 in an article. This rationale aligns with the principle of KSR for a simple substitution of one known element for another to obtain predictable results, see MPEP 2143.
The limitation of claims 5 and 16 include those from claim 3, it is included in the rejections stated above and is read on by the motivation set forth by Brader et al to optimize the concentration of RNA and to utilize mRNA for the LNP formulation in the article.
Therefore, claim 3,5,and 16 is obvious over Brader et al in view of Eygeris et al.
Regarding claim 17-18: Following the discussion above, the mRNA-1273 is a 3828 nucleotide sequence. Brader et al teaches that there are embodiments with the polynucleotide can be greater than at least 400 nucleotides in length all the way to at least 5000 nucleotides or greater than 5000 nucleotides (See, ¶00299). The mRNA from the discussion above reads on the ranges for both claims 17-18.
Therefore, claims 17-18 are obvious over Brader et al in view of Eygeris et al.
Regarding claim 20: Following the discussion above, the mRNA-1273 encodes for the spike protein of SARS-CoV-2. This reads on the claim, wherein the infectious disease antigen is a SARS-CoV-2 prefusion stabilized Spike (S) protein.
Therefore, claim 20 is rendered obvious over Brader et al in view of Eygeris et al.
Regarding claim 23: Following the discussion above, Brader et al teaches that a pharmaceutical composition in accordance with the present disclosure may be prepared, packaged, and or sold in bulk as a single unit dose, and or as a plurality of single unit doses (See, ¶00467). The limitation of claim 23 include those from claim 3, it is included in the rejections stated above and is read on as the pharmaceutical composition comprises of the elements discussed for the product of claim 3 taught by Brader et al.
Therefore, claim 23 is rendered obvious over Brader et al and in view of Eygeris et al.
Regarding claims 26-27 and 60: Following the discussion above about the amount of RNA in the article of claim 3, the degradation of the RNA of the product in the article does not change the product itself. The type of degradation, i.e. transesterification, and the percentage of the degradation within the article has no patentable weight as a limitation. The limitation of claims 26-27 and 60 include those from claim 3, it is included in the rejections stated above and is read on by the motivation set forth by Brader et al to optimize the concentration of RNA in the article.
Therefore, claims 26-27 and 60 are rendered obvious over Brader et al in view of Eygeris et al.
Regarding claims 39 and 61: Following the discussion above, Brader et al teaches that storage refers to storing the disclosed LNP formulation product either in its final state or in-process state before final packing and the modes of storage include vials and syringes (See, ¶00140). Brader et al teaches that a pharmaceutical composition in accordance with the present disclosure may be prepared, packaged, and or sold in bulk as a single unit dose, and or as a plurality of single unit doses (See, ¶00467).
Therefore, the method of filling the article of claim 39 is implicit based on the Brader et al and the packaging and or storing the formulations in vials and syringes.
The limitations of claim 61 are read on by Brader et al and the storing and packaging of the formulation in vials and syringes.
Therefore, claims 39 and 61 are rendered obvious over Brader et al and in view of Eygeris et al.
Regarding claim 43: Following the discussion above about the amount of RNA in the article of claim 3, the limitation of claim 43 is included in the rejections stated above and is read on by the motivation set forth by Brader et al to optimize the concentration of RNA for the LNP formulation in the article.
Therefore, claim 43 is rendered obvious over Brader et al and in view of Eygeris et al.
Regarding claims 56-57: Following discussion above about the amount of RNA in the article of claim 3, the limitations of claims 56 and 57 are included in the rejections stated above and is read on by the motivation set forth by Brader et al to optimize the concentration of RNA.
Therefore, claims 56 and 57 are rendered obvious over Brader et al in view of Eygeris et al.
Regarding claims 58-59: Following the discussion above, the mRNA-1273 vaccine is 3828 nucleotides. This is slightly below the size required by claims 58-59, however, Brader et al teaches that the amount of therapeutic (e.g. RNA, mRNA) in a LNP may depend on the size, composition, desired target and or application of the LNP, as well as the properties of the therapeutic(See, ¶00450).
It would have been prima facie obvious for one of ordinary skill to optimize the number of nucleotides of the mRNA based on the motivation provided by Brader et al to enhance the efficacy of the liquid pharmaceutical in the article for a desired target. As such, determining the number of nucleotides would have been a matter of routine optimization. See MPEP 2144.05.
Therefore, claims 58-59 are rendered obvious over Brader et al in view of Eygeris et al.
Regarding claim 62: Following the discussion above, Brader et al teaches a pharmaceutical composition may be prepared in a variety of forms suitable for a variety of routes and methods of administrations, including liquid dosage forms, injectable forms and other routes (See, ¶00468). Brader et al teaches that the stabilized LNP formulation disclosed may have the feature of being an aqueous or frozen formulation (See, ¶0006). This reads on the limitations of claim 62.
Therefore, claim 62 is rendered obvious over Brader et al in view of Eygeris et al.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Brader et al and Eygeris et al as applied to claims 3,5,16-18,23,26-27,39,43, and 56-62 above, and further in view of Rauch et al (US 2019/0351048 A1).
Following the discussion above, Brader et al teaches a stabilized LNP formulation comprising of a plurality of LNPs and a stabilizing agent that mitigates the degradation of LNPs or subpopulation. The LNP formulation (either liquid or lyophilized) that is stored at about 4 °C or higher (See, ¶00139). Brader et al teaches that storage refers to storing the disclosed LNP formulation product either in its final state or in-process state before final packing and the modes of storage include vials and syringes (See, ¶00140). Brader et al further teaches that there is a particular embodiment where the formulation disclosed is stabilized at a temperature ranging between -20°C and 4°C at a nucleic concentration (e.g. an mRNA concentration) of up to 2 mg/mL for at least 12 weeks (See, ¶00160). Eygeris et al teaches the use of mRNA from SAR-CoV-2 with LNPs for vaccines.
Brader et al and Eygeris et al do not teach the use of SARS-CoV-2 prefusion stabilized Spike (S) protein as the infection disease antigen in the article formulation.
Rauch et al discloses an invention such that mRNAs suitable for use in mRNA-based vaccines against infections with MERS coronaviruses (See, ¶0001). Rauch et al teaches that MERS-CoV is a member of the severe acute respiratory syndrome coronavirus (SARS-CoV) (See, ¶0002). Rauch et al discloses an mRNA comprising at least one coding region encoding at least one antigenic peptide or protein derived from MERS-CoV or a fragment or variant of such a protein, induces efficiently antigen-specific immune responses against MERS-CoV (See, ¶0123). Rauch et al teaches an invention of a mRNA-based vaccine comprising mRNA encoding at least one antigen comprising of a MERS coronavirus protein, preferably a spike protein (S), are extremely effective in inducing an antigen specific immune response against MERS coronavirus (See, ¶0124). Rauch et al teaches that MERS coronavirus full length spike (S) protein consist of 1353 amino acids and in specific embodiments, full length spike (S) protein is modified in such a way that the prototypical prefusion conformation is stabilized (See, ¶0149).
Given that Brader et al teaches the use of mRNA in their methods, Eygeris et al teaches the use of unspecific mRNA related to SARS-CoV-2, and Rauch et al teaches the use of prefusion stabilized Spike (S) protein in a mRNA vaccine, there is a reasonable expectation that they would work equivalently. Brader et al and Eygeris et al provided motivations to optimize the mRNA utilized in the method and Rauch et al motivated to use of the Spike (S) protein due to the elicitation of an extremely effective antigen specific immune response. This conclusion of obviousness is based on the teaching suggestion motivation rationale. One would have had a reasonable expectation of success of combining the prefusion stabilize spike (S) protein of Rauch et al with the teachings of Brader et al and Eygeris et al.
Therefore, claim 20 is obvious over Brader et al and Eygeris in further view of Rauch et al.
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 for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3,5,16-18,23,26,27,39,43,46, and 56-62 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5,16-20,23-24,33,37,40,44-47 of copending Application No. 17/925,114 (reference application) in view of Eygeris et al (Nano Letters, 2020).
Regarding claim 3: Reference claim 3 recites an article, comprising: a liquid pharmaceutical composition comprising RNA formulated in a lipid nanoparticle, liposome, or lipoplex; wherein the article has a shelf-life of at least three months when stored at a temperature of greater than 0 °C and less than or equal to 10 °C; and wherein the article comprises a total amount of full length RNA, and the total amount of full length RNA is greater than or equal to (1 + the fraction of the full length RNA that would degrade in the liquid pharmaceutical composition over the shelf-life of the article) x (an individual dose of the full length RNA) x (the number of individual doses of the liquid pharmaceutical composition in the article).
The reference claim does not teach the use of RNA that encodes an infectious disease antigen, wherein the infectious disease is caused by or associated with SARS-CoV-2.
Eygeris et al teaches LNP packaged mRNA vaccines have been deployed against infectious diseases such as COVID-19 (See, Abstract). Eygeris et al teaches that the first potential mRNA vaccine against SARS-CoV-19 (SARS-CoV-2) was administered just 63 days after the identification of the virus sequence (See, p4543 ¶1).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the RNA in the reference application in the context of LNP formulation in the article with mRNA used in vaccines for SARS-CoV-2, taught by Eygeris et al for a similar purpose.
The use of mRNA encoding for SARS-CoV-2 in place of the non-specific RNA in reference application, is a predictable use of prior art elements according to their established functions, leading to the predictable result of an LNP formulation where the RNA encodes for SARS-CoV-2 in an article. This rationale aligns with the principle of KSR for a simple substitution of one known element for another to obtain predictable results, see MPEP 2143.
Although the claims at issue are not identical, they are not patentably distinct from each other because the steps provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 3, thus instant claim 3 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 5: Reference claim 5 recites the article of claim 3, wherein the total amount is greater than or equal to 1.05 x (an individual dose of the liquid pharmaceutical composition), such as greater than or equal to 1.2 x (an individual dose of the liquid pharmaceutical composition).
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because the steps provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 5, thus instant claim 5 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 16: Reference claim 16 recites the article of claim 3, wherein the RNA comprises mRNA.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because the steps provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 16, thus instant claim 16 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claims 17-18: Reference claim 17 recites the article of claim 3, wherein the RNA comprises greater than or equal to 400 nucleotides. Reference claim 18 recites the article of claim 3, wherein the RNA comprises less than or equal to 15,000, 14,000, 13,000, 12,000, 11,000, 10,000, 9000, 8000, 7000, or 6000 nucleotides.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because the range of nucleotides provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 17 and 18, thus instant claim 17 and 18 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 23: Reference claim 20 recites a pharmaceutical composition comprising mRNA encapsulated in a lipid nanoparticle, wherein the composition comprises a total amount of intact mRNA that is greater than an effective amount of intact mRNA, and wherein the composition comprises at least the effective amount of the intact mRNA after storage of the composition for a period of time.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because the pharmaceutical composition provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 23, thus instant claim 23 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 26: Reference claim 23 recites the article of claim 3, wherein the degradation is from transesterification of the full length RNA.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because the type of degradation provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 26, thus instant claim 26 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 27: Reference claim 24 recites the article, wherein the degradation is greater than or equal to 5% of the total amount of full length RNA in the liquid pharmaceutical composition per month.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because the type of degradation and the range provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 27, thus instant claim 27 is rendered obvious over the co-pending application in view of Eygeris et al.
Regrading claim 39: Reference claim 33 recites a method of filling an article, comprising: adding RNA formulated in a lipid nanoparticle, liposome, or lipoplex to the article to form an amount of a liquid pharmaceutical composition in the article; wherein the amount is greater than or equal to (1 + the fraction of the RNA that would degrade in the liquid pharmaceutical composition over the shelf-life of the article) x (an individual dose of the liquid pharmaceutical composition) x (the number of individual doses in the article).
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because method provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 39, thus instant claim 39 is rendered obvious over the co-pending application in view of Eygeris et al.
Regrading claim 43: Reference claim 37 recites the article of claim 3, wherein at least 40% of the total amount of full length RNA in the liquid pharmaceutical composition is full length if stored for three months at a temperature of greater than 0 °C and less than 10 °C.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because method provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 43, thus instant claim 43 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 46: Reference claim 40 recites a method of delivering an effective dose of an RNA to a subject, comprising; administering a liquid pharmaceutical composition comprising an RNA encoding a protein formulated in a lipid carrier to a subject, wherein a total dose of the RNA is administered to the subject, and wherein the total dose of RNA administered to the subject is at least 5% greater than an effective dose of the RNA.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because method provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 46, thus instant claim 46 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 56: Reference claim 44 recites the article of claim 3, wherein the article comprises a total amount of RNA and wherein the total amount of RNA includes 40%-95% full length RNA and 5%-60% RNA that is less than full length RNA.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because method provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 56, thus instant claim 56 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 57: Reference claim 45 recites the article of claim 3, wherein the total amount of full length RNA is greater than an effective amount of full length RNA, and wherein the liquid pharmaceutical composition comprises at least the effective amount of the full length RNA after storage of the liquid pharmaceutical composition for the shelf-life of the article.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because method provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 57, thus instant claim 57 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 58-59: Reference claim 46 recites the article of claim 3, wherein the RNA comprises greater than or equal to 500, 1000, 2000, 3000, 4000, 5000, 6000, 7000, or 8000 nucleotides.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because the range nucleotides in the RNA provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 58-59, thus instant claim 58-59 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 60: Reference claim 47 recites the article of claim 3, wherein the degradation is greater than or equal to 7%, greater than or equal to 8%, greater than or equal to 9%, greater than or equal to 10%, or greater than or equal to 12% of the total amount of full length RNA in the liquid pharmaceutical composition per month.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because method and degradation values provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 60, thus instant claim 60 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 61: Reference claim 4 recites the article of claim 3, wherein the article comprises a vial, a syringe, a cartridge, an infusion pump, and/or a light protective container.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because method provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 61, thus instant claim 61 is rendered obvious over the co-pending application in view of Eygeris et al.
Regarding claim 62: Reference claim 19 recites the article of claim 3, wherein the liquid pharmaceutical composition is formulated in an aqueous solution.
Following the discussion above surrounding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because method provided in the reference application and the specificity of the RNA used in the method provided by Eygeris et al, reads on the limitations of instant claim 62, thus instant claim 62 is rendered obvious over the co-pending application in view of Eygeris et al.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/CAROLINE M LARA/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633