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 .
Response to Amendment
An amendment filed on 16 July 2026 is acknowledged. Claims 36 and 52 are amended, and claim 53 is newly added. Claims 36-53 are pending and are presented for examination on the merits.
In response to the amendments filed on 16 July 2026, the rejections under 35 U.S.C. 112(b) are changed; the rejections under 35 U.S.C. 112(a) are withdrawn; and the rejections under 35 USC 103 are modified.
Claim Rejections - 35 USC § 112
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.
Claims 36-53 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.
Independent claim 36 recites the limitation "the sample" in step c). There is insufficient antecedent basis for this limitation because the claim previously introduces both "a sample" in step a) and "a purified target RNA sample" in step b). Dependent claim 53 also recites this limitation.
Dependent claims 37-53 are rejected for depending from independent claim 36.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 36-41 and 44-53 are rejected under 35 U.S.C. 103 as being unpatentable over Bancel (US 2016/0024547, IDS; previously relied upon) in view of International Council for Harmonisation (IHC) ("ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology," 2006; newly cited), Spivak (US 2016/0017313, IDS; previously relied upon), and Azarani ("RNA analysis by ion-pair reversed-phase high performance liquid chromatography," Nucleic Acids Research, 2001, Vol. 29, No. 2, e7, IDS; previously relied upon).
Regarding claim 36, Bancel discloses a method for producing a pharmaceutical RNA product ([0005], [0007], producing clinical grade mRNA, [0023]), the method comprising the steps of:
a) preparing a sample comprising a target RNA by in vitro transcription (RNA transcript, abstract), wherein the target RNA is a mRNA of 500 to 10,000 nucleotides in length ([0066], [0082]) having a 5' Cap ([0076]) and poly(A) sequence (poly-A tail, [0076], [0084]);
b) purifying the target RNA, thereby providing a purified target RNA sample (Fig. 1; capping can be performed before further purification of the RNA transcript, [0070]; DNA template is separated chromatographically from the RNA transcript, [0089]; poly A capture-based affinity chromatography can be used to separate adenylated RNA from short aborts and other truncates, [0091]; [0095]);
c) detecting by-products in a portion of the purified target RNA sample by HPLC to determine a measure of the total amount of all by-products present within the sample (analysis performed after additional purification steps, [0095]; analytical reverse phase HPLC, [0096]; purity can be measured by peak area of full-length RNA transcript relative to total peak, which includes total by-products [0097]); and
d) further processing the remainder of the purified target RNA sample to produce a pharmaceutical RNA product ([0005], [0007], [0023]).
Bancel does not explicitly teach "determin[ing] the total amount of all by-products present within the sample by calculating the area of all peaks representing by-products and relating this area to the area of the peak of the target RNA."
However, Bancel teaches that purity can be determined via reverse phase HPLC and measuring peak area of full length RNA transcript relative to total peak ([0097]). Bancel's total peak area is the arithmetic sum of Bancel's peak area of full length RNA transcript (the claimed area of the peak of the target RNA) and the area of all peaks representing by-products. Accordingly, the claimed total amount of all by-products present within the sample can be obtained by a simple subtraction of Bancel's peak area of full length RNA transcript from Bancel's total peak area.
The International Council for Harmonisation (IHC), in guidance for validating analytical procedures for quantifying impurities in a drug product, discloses use of chromatography procedures (section 1.2, page 9) and teaches that total impurities are to be determined by area percent "with respect to the major analyte" (section 4.2, last sentence, page 11). The major analyte of the IHC guidance corresponds to the target RNA of Bancel. Accordingly Bancel in view of IHC teaches determining the total amount of all by-products present within the sample by calculating the area of all peaks representing by-products and relating this area to the area of the peak of the target RNA.
For the benefit of regulatory compliance, it would have been obvious to one of ordinary skill in the art before the time of filing to assess a drug product for total impurities according to the guidance of the IHC, thereby modifying Bancel's purity determination such that the total amount of all by-products present within the sample are determined by calculating the area of all peaks representing by-products and relating this area to the area of the peak of the target RNA.
While Bancel does not explicitly teach that said by-products comprise by-products having a length of 5 to 500 nucleotides, Bancel discloses by-products that are "short aborts and other truncates ([0091]). Given that Bancel discloses that the RNA transcript is 500 to 10,000 nucleotides in length ([0066], [0082]), it is implicit or obvious to Bancel that short aborts and other truncates of a RNA transcript that is 500 to 10,000 nucleotides in length comprise by-products having a length of 5 to 500 nucleotides.
Bancel is silent regarding the conditions of the analytical reverse phase HPLC of step c) and therefore does not disclose that the HPLC of step c) is performed at a temperature of at least 55 °C and uses a mixture of an aqueous solvent and an organic solvent as mobile phase and wherein the proportion of organic solvent is increased during the HPLC to provide a gradient. However, these conditions are known for analytical HPLC.
The analogous prior art of Spivak discloses a method for producing a pharmaceutical RNA product (mRNA, "large scale manufacturing of therapeutics," abstract), comprising
a) preparing a sample comprising a target RNA by in vitro transcription ([0057], [0072]), wherein the target RNA is a mRNA of 500 to 10,000 nucleotides in length (abstract, [0008], [0076], [0099]) having a poly(A) sequence ([0057], [0118]);
b) purifying the target RNA (Fig. 1B steps 112 and 114; P1 purification process, [0036], [0115]; or P2 purification process, [0037], [0115], which is affinity chromatography, [0103]), where by-products comprise short RNA transcripts of less than 400 nucleotides ([0005], [0121]), thereby providing a purified target RNA sample;
c) detecting by-products in a portion of the purified target RNA sample by HPLC (Figs. 1B step 116, 10A, and 10B, [0036], [0037], [0074]; [0115]) to determine the amount of an individual by-product ("quantifying each peak to get the percentage of each impurity," [0085]), said by-products having a shorter length (short transcripts, [0051], "different lengths of mRNA, [0115], [0118]), wherein the HPLC of step c) uses a mixture of an aqueous solvent and an organic solvent as mobile phase (Mobile Phase A and B, Table 4, page 8) and wherein the proportion of organic solvent (acetonitrile in Mobile Phase B, Table 4, page 8) is increased during the HPLC to provide a gradient (%B from initial time to 44 minutes, Table 5, page 8); and
d) further processing the remainder of the purified target RNA sample to produce a pharmaceutical product comprising the final RNA product (abstract, [0005], [0074]).
Spivak teaches that step 116 of Fig. 1B (RP-HPLC of step c) "can be performed under denaturing conditions, non-denaturing conditions, or partially denaturing conditions" ([0087]) and that denaturing conditions can include thermally denaturing conditions of elevated temperature of 55 to 75 °C ([0078]). Spivak cites Azarani ([0142]).
The analogous prior art of Azarani discloses analysis of an RNA ladder having lengths ranging from 155 to 1770 nucleotides (Fig. 1) and transcription reaction products (Fig. 3) by IP RP HPLC under "fully denaturing conditions at 75 °C (page 2, right col., first para.). Azarani teaches that "we noticed a decrease in resolution for RNA at lower analysis temperatures (Fig. 2). Consequently, all RNA analyses were performed at 75°C" (page 3, first para.).
For the benefit of selecting known HPLC conditions that provide improved resolution of RNA, it would have been obvious to one of ordinary skill in the art before the time of filing that the analytical reverse phase HPLC of Bancel is applied using the conditions disclosed by Spivak and Azarani such that the HPLC of step c) is performed at a temperature of at least 55 °C and uses a mixture of an aqueous solvent and an organic solvent as mobile phase and wherein the proportion of organic solvent is increased during the HPLC to provide a gradient.
The use of a known technique to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 37, Bancel discloses that in one embodiment the method excludes the use of DNase ([0010], [0042], [0091]) and therefore discloses that method does not comprise a step of treating the target RNA with a ribozyme. Moreover, Spivak's method of HPLC analysis does not comprise a step of treating the target RNA with a ribozyme, given that the presence of fragmentation is what is being studied in the stability tests ([0114]), and Azarani teaches away from exogenous RNAses because of the potential for RNA degradation (page 1, first para. of introduction).
Regarding claim 38, Bancel discloses that the by-products comprise at least two nucleic acid molecules with different length ("RNA transcripts that do not contain Poly A stretches (short aborts [plural] and other truncates [plural] formed during in vitro transcription)," [0091]). Likewise, Spivak teaches that the impurities are different length mRNA ([0115], [0118]). Moreover, Azarani's Fig. 3B illustrates that by-products in the crude transcript comprise at least two nucleic acid molecules with different lengths. The two left shoulder peaks of the target 5219 nucleotide peak are smaller size RNA transcripts and/or degraded RNA that would be expected to be difficult to resolve from the collected fraction of the target 5219 nucleotide peak.
Regarding claim 39, Bancel discloses that the RNA transcript includes a poly-A tail ([0076]), wherein a poly-A tail is at the 3' terminus ([0008], [0038]). Bancel further discloses that the short aborts and other truncates formed during in vitro transcription are RNA transcripts that do not contain Poly A stretches ([0091]). Accordingly, Bancel discloses that the by-products do not comprise the 3' terminus of the target RNA. Moreover, Spivak discloses that short abort sequences are generated during transcription ([0008], [0051]), and Azarani teaches that "early termination products of transcription also result in shorter RNA fragments" (page 3). One of ordinary skill in the art would understand that RNA polymerase builds an RNA strand in the 5' to 3' direction, and that short aborts and early termination products of transcription would result in a shorter RNA fragment that does not comprise the 3' terminus of the target RNA.
Regarding claim 40, both Spivak (Fig. 1B, [0087]) and Azarani (page 1, last two Introduction paragraphs) disclose performing RP-HPLC under denaturing conditions, which results in any short RNAs being single-stranded.
Regarding claim 41, Bancel is silent as to whether step b) is performed under denaturing conditions, including thermal denaturing conditions ([0078]). Spivak discloses that step b) is performed under denaturing conditions (Fig. 1B, steps 112 and 114, [0087]). Azarani discloses analysis of an RNA ladder having lengths ranging from 155 to 1770 nucleotides (Fig. 1) and transcription reaction products (Fig. 3) by IP RP HPLC under "fully denaturing conditions at 75 °C (page 2, right col., first para.). Azarani teaches that "we noticed a decrease in resolution for RNA at lower analysis temperatures (Fig. 2). Consequently, all RNA analyses were performed at 75°C" (page 3, first para.). For the benefit of selecting known HPLC conditions that provide improved resolution of RNA, it would have been obvious to one of ordinary skill in the art before the time of filing that the purification chromatography of Bancel is applied using the conditions disclosed by Spivak and Azarani such that step b) is performed under denaturing conditions.
The use of a known technique to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 44, Bancel discloses that the HPLC in step c) is reversed-phase HPLC (analytical reverse phase HPLC, [0096]) but does not disclose ion-pair, reversed-phase HPLC. Azarani teaches using ion-pair, reversed-phase HPLC to determine the quality and purity of RNA transcripts (page 3, second and third para.). Azarani teaches that components of an RNA ladder having lengths ranging from 155 to 1770 nucleotides were resolved by IP RP HPLC (abstract). For the benefit of resolution of small RNAs, it would have been obvious to one of ordinary skill in the art before the time of filing the replace the analytical RP HPLC of Spivak with the analytical IP RP HPLC of Azarani.
The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding claims 45-47, Bancel discloses that the HPLC in step c) is reversed-phase HPLC (analytical reverse phase HPLC, [0096]) but does not explicitly disclose that the HPLC in step c) uses a carbon-chain bonded silica column or that the column has a particle size of 0.5 to 5 micrometers and/or a pore size of 50 to 300 angstrom. Spivak discloses that the HPLC in step c) uses a Waters XBridge C18 column, 2.1 x 50 mm (Table 4, page 8) without disclosing the particle size or the pore size of this column. The examiner takes official notice that a Waters XBridge C18 column is a carbon-chain bonded silica column. The examiner takes official notice that a Waters XBridge C18 column, 2.1 x 50 mm is available with a particle size of 0.5 to 5 micrometers and with a pore size of 50 to 300 angstrom. For the benefit of selecting from a known type of Waters XBridge C18 column, it would have been obvious to one of ordinary skill in the art at the time of filing that Bancel's analytical reverse phase HPLC uses a carbon-chain bonded silica column having a particle size of 0.5 to 5 micrometers and/or a pore size of 50 to 300 angstrom.
The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding claim 48, Spivak discloses that at the beginning of the HPLC, the mobile phase contains a 5% proportion of organic solvent (20% Mobile Phase B, Table 5, where Mobile Phase B is 25% acetonitrile, Table 4, page 8), relative to the mobile phase, the rest being the aqueous solvent (TEAA buffer in Mobile Phases A and B, Tables 4 and 5, page 8).
Regarding claims 49-51, Spivak discloses that the organic solvent is acetonitrile (Table 4, page 8) and that the aqueous solvent comprises a buffer (triethylammonium acetate, TEAA, buffer Table 4, page 8).
Regarding claim 52, as applied to the rejection of claim 36 above, Spivak teaches that step 116 of Fig. 1B (RP-HPLC of step c) "can be performed under denaturing conditions, non-denaturing conditions, or partially denaturing conditions" ([0087]) and that denaturing conditions can include thermally denaturing conditions of elevated temperature of 55 to 75 °C ([0078]). Spivak cites Azarani ([0142]), and Azarani discloses resolution of RNA fragments at 65 °C (Fig. 2, lower trace). A temperature of 65 °C is interpreted as being "about 60 °C," as claimed.
For the benefit of selecting known HPLC conditions, it would have been obvious to one of ordinary skill in the art before the time of filing that the analytical reverse phase HPLC of Bancel is applied using the conditions disclosed by Spivak and Azarani such that the HPLC of step c) is performed at a temperature of at "about 60 °C." The use of a known technique to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 53, as applied to the rejection of claim 36 above, Bancel in view of IHC discloses that step c) comprises detecting by-products in a portion of the purified target RNA sample by HPLC to determine the total amount of all by-products present within the sample by calculating the area of all peaks representing by-products and relating this area to the area of the peak of the target RNA. Regarding the limitation that the detection of step c is "with single-nucleotide resolution of RNA oligomers," it is presumed to be either inherent to the HPLC conditions of Azarani, or in the alternative obvious with routine modification, that a pair of RNA oligomers with a single-nucleotide difference can be resolved. Evidence for inherency of this functional property is that Azarani discloses the claimed HPLC conditions. Regarding obviousness, optimizing peak resolution through experimental evaluation of HPLC solid phase, mobile phase, and temperature is routine. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Moreover, in this finding of obviousness of the limitations of claim 53, it is noted that whether or not individual by-product peaks are resolved from each other does not affect the claimed step of determining the total amount of all by-products by calculating the area of all peaks representing by-products and relating this area to the area of the peak of the target RNA.
Claims 42 and 43 are rejected under 35 U.S.C. 103 as being obvious over Bancel in view of IHC, Spivak, and Azarani as applied to claims 36-41 and 44-53 above, further in view of Ketterer (US 2010/0048883, IDS; previously relied upon).
Regarding claims 42 and 43, Bancel does not disclose that step b) comprises a step of purifying the target RNA by HPLC or reversed-phase HPLC.
Spivak discloses that purifying step b) is a "P1 purification process" ([0036], [0115]), which is not explained, or a "P2 purification process" ([0037], [0115]) which is affinity chromatography, [0103]), or uses a "reversed phase" (Fig. 1B, step 112, [0085]). While Spivak's description of the purifying step b) as using "reversed phase" strongly suggests reversed-phase HPLC, given the common use of reversed-phase HPLC, Spivak does not explicitly teach that this reversed phase is reversed-phase HPLC.
In the analogous art of the preparative-scale preparation of mRNA for therapeutic purposes ([0001], [0019]), Ketterer teaches preparative purification of transcripted RNA ([0012]) via reversed-phase HPLC (abstract, [0007]) using completely denaturing conditions to achieve better separation ([0060]). Ketterer discloses that high-purity RNA-containing fractions may be separated from other RNA-containing fractions which still contain undesired impurities, albeit in very small quantities ([0059]). Ketterer discloses that larger RNA as well as smaller RNA fragments with a length of 20-200, 20-100, 20-50 or 20-30 nucleotides may be separated ([0018], [0027]).
For the benefit of providing purer RNA on a preparative scale via a known technique, it would have been obvious to one of ordinary skill in the art before the time of filing that Bancel's purifying step is reversed-phase HPLC, as taught by Ketterer.
The use of a known technique to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Response to Arguments
Applicant's arguments filed on 16 July 2026 have been considered and are not fully persuasive and/or are moot in view of the new grounds of rejection.
The prior art of IHC has been added to the rejections of the claims under 35 USC 103 to address the newly added limitation of "determin[ing] the total amount of all by-products present within the sample by calculating the area of all peaks representing by-products and relating this area to the area of the peak of the target RNA."
Regarding the rejection of claims 42 and 43 over the additional reference of Ketterer, Applicant argues the following (bolding added):
The rejection of claims 42 and 43 also illustrates the overextension of the proposed combination. The asserted combination would require modifying Bancel's production method to include Ketterer's preparative HPLC purification for step b), while separately relying on Bancel, Spivak, and Azarani for an analytical HPLC detection step c). The Action has not adequately explained why a person of ordinary skill would have been motivated to construct that two-HPLC workflow and, in doing so, arrive at the claimed portion/remainder quality-control arrangement with the amended aggregate by-product calculation. Ketterer's preparative purification disclosure therefore does not overcome the deficiencies of the base combination.
In response, the use of two sequential HPLC steps, the first preparative and the second analytical, is conventional in analytical chemistry. All of Bancel, Spivak, and Azarani disclose two sequential chromatography steps, the second one being an analytical HPLC step. Spivak further describes the initial purifying step as using "reversed phase" (step 112, Fig. 1B, copied below), which strongly suggests reversed-phase HPLC. Azarani also discloses two sequential HPLC steps (para. bridging pages 6-7). The two sequential HPLC steps of claims 42 and 43, when considering the limitations of claims 42 and 43 as a whole, do not patently distinguish the claims from the prior art.
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE ADAMS whose telephone number is (571)270-5043. The examiner can normally be reached on M, T, Th, and F, 12-4 P.M.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE ADAMS/ Examiner, Art Unit 1797
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797
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