Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.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 March 31, 2026 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Status of Claims
Claims 1, 2, 4, 5, 8, 11-18 and 101-108 are currently pending. Claims 1, 2, 4, 5, 8, 11-13, 15, 16-18, 104, 106 and 107 have been amended by Applicants’ amendment filed 03-31-2026. Claims 9 and 10 have been canceled by Applicants’ amendment filed 03-31-2026. No claims have been added by Applicants’ amendment filed 03-31-2026.
Applicant's election without traverse of Group I, claims 1-17, directed to a method of manufacturing a therapeutic polynucleotide using a system; and the election without traverse of Species as follows:
Species (A): wherein purifying the therapeutic polynucleotide comprises removing double-stranded mRNA using a cellulose material within the one or more reactors (instant claim 7);
Species (B): the method of claim 1 further comprising formulating the therapeutic polynucleotide with a delivery vehicle in one or more reactors (instant claim 3);
Species (C): wherein the system transports the reagents between the one or more fluid depots and the plurality of reactors by fluid power (instant claim 11);
Species (D): wherein the therapeutic polynucleotide is an mRNA (instant claim 9), in the reply filed August 3, 2023.
Claims 18-20 were previously withdrawn further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim. It is noted that Applicant specifically withdrew claim 18, drawn to a therapeutic polynucleotide made using the method of claim 1, in the reply filed 08-03-2023.
Claims 2, 8, 10, 13, 15-17 102-105 and 107 were previously withdrawn, and claim 108 is newly withdrawn, from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
The restriction requirement was deemed proper and was made FINAL.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 1, 4, 5, 11, 12, 14, 101 and 106 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed August 10, 2020 claims the benefit of US Provisional Patent Application 62/914,374, filed October 10, 2019; and US Provisional Patent Application 62/885,170, filed
August 9, 2019; and US Provisional Patent Application 62/885,159, filed August 9, 2019.
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, US Provisional Patent Applications 62/914,374, filed October 10, 2019; 62/885,170, filed August 9, 2019; and 62/885,159, filed August 9, 2019, fail to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. The specific method steps recited in independent claim 1 does not have support for: a fluid permeable sponge that is manipulatable by an elastic membrane; encapsulating the single-stranded mRNA therapeutic polynucleotide with an amphipathic nanoparticle in one or more second chamber portions; and/or delivering a synthetic double-stranded DNA template to one or more of the plurality of second chamber portions. Therefore, the priority date for the presently claimed invention is August 10, 2020, the filing date of US Patent Application 16/989,833.
Applicants are invited to specifically indicate the location of the cited phrase pertinent to claim 1 of the instant application.
Response to Arguments
Applicant’s arguments filed March 31, 2026 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) Applicant has provided a Table listing where support can be found for limitations in the instant claims including: (i) support for “fluid permeable insert” can be found in USSN 62/914374 in paras. [0008]-[0010], [0067]-[0082], [0241], [0245] and [0252]-[0254]; Figs. 19B, and 20A-B; USSN 62/885170 in paras. [0061] and [0156], and claims 6 and 7; and USSN 62/885159 para. [0125]; and claims 65 and 66 (Applicant Remarks, pg. 8, last partial paragraph through pg. 9); and (ii) support for “delivering a synthetic double-stranded DNA template to one or more of the plurality of second chamber portions” can be found in USSN 62/914374 in paras. [0013]-[0017]; [0022]-[0027], [0033]-[0035], [0050]-[0065],[0072], [0107], [0108], [0256]; and Figures 6 and 7; USSN 62/885170 in paras.[0012], [0022], and [0048]; and USSN 62/885159 paras.[0140]-[0143], [0145]; and claims 41-48 and 54-61.
Regarding (a), as an initial matter, the as-filed Specification and original claims do not teach or recite a definition for the term “sponge.” It is known that a “sponge” is substance that is full of holes, soft when wet, and able to absorb a lot of liquid as evidenced by Cambridge Dictionary (pg. 3, first full paragraph); in microfluidics, a “sponge” is a bioinspired biomolecule cleaning device analogous to a natural porous sponge for highly efficient molecule adsorption as evidenced by Fan (pg. 8375, Figure 1); and a polyurethane, cellulose and natural sponges are known in the art, which are used as substrates for microfluidic sampling as evidenced by Ding (Abstract). Clearly, the term “fluid-permeable sponge” imparts certain structural characteristics to the component, which are not associated with the term ”permeable insert material” as taught in USSN 62/914374.
The Examiner did not find a teaching for: (1) “fluid permeable sponge being located within a second chamber portion” in any of the cited Specification paragraphs, figures and/or claims cited by Applicant. USSN 62/914374 – the Specification teaches a permeable insert material, which can include a cover, which can be fibrous or layered. Figure 19 teaches a permeable insert, 1969; Figure 20A teaches a solid porous insert; Figure 20B teaches a porous collagen insert. USSN 62/885170 – the Specification teaches reactors comprising cellulose; and a cellulose membrane, while the claims recite one or more reactors and the use of cellulose. USSN 62/885159 – the Specification and claims teach incorporating a material within the fluid side 917 of a chamber or channel, where the material can be cellulose material. However, there is no teaching of a fluid permeable sponge including a fluid permeable sponge that is manipulatable by an elastic membrane.
The Examiner did not find a teaching for (2) “delivering a synthetic double-stranded DNA template to one or more of the plurality of second chamber portions.” USSN 62/914374 – the Specification teaches a microfluidic path device for forming a DNA template; delivering a template precursor material from one or more storage depots to a first reactor region; a method of making synthetic dsDNA template for in vitro transcription using a closed path system; pneumatically transferring the branched amplified DNA ligated product to a digestion reactor; delivering a DNA template through directed fluid flow; and transferring mRNA away from the first reactor. USSN 62/885170 – the cited portions of the Specification teach that permeable implants inserts can be configured to remove an impurity; methods of forming a DNA template for IVT with a microfluidic path device; and transporting reagents between one or more storage depots of the plurality of storage depots and a plurality of reactors on the one or more microfluidic devices. USSN 62/885159 – the Specification teaches that a therapeutic mRNA is produced a first microfluidic path device may be used for DNA template production as part of a template microfluidic path device; the device can include input ports, and chambers; while the claims recite fluidic lines; coordinating the movement of fluid through a plurality of chambers; and fluid ports connected to chambers. However, there is no teaching of “delivering a synthetic double-stranded DNA template to one or more of the plurality of second chamber portions.”
It is also noted that the US Provisional Patent Applications do not teach the limitation of “encapsulating the single-stranded mRNA therapeutic polynucleotide with an amphipathic nanoparticle in one or more second chamber portions.” Thus, the priority date for the presently claimed invention is August 10, 2020, the filing date of US Patent Application 16/989,833.
Withdrawn Objections/Rejections
Applicants’ amendment and arguments filed March 31, 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or
objection not specifically addressed below are herein withdrawn.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 4, 5, 11, 12, 14, 101 and 106 is withdrawn under 35 U.S.C. 103 as being unpatentable over Stern et al. (hereinafter “Stern”) (US Patent Application Publication No. 20120164036, published June 28, 2012; of record) in view of Baiersdorfer et al. (hereinafter “Baiersdorfer”) (US Patent Application Publication 20190153425, published May 23, 2019; effective filing date April 22, 2016; of record) as evidenced by Jovanovich et al. (hereinafter “Jovanovich”) (US Patent Application Publication 20070248958, published October 25, 2007; of record); and Barbosa et al. (hereinafter “Barbosa”) (Bioresources, 2013, 8(1), 1043-1054; of record); and BpH (BiopHorectics, 2025, 1-2; of record); and Ziegenhals et al. (hereinafter “Ziegenhals”) (Frontiers in Molecular Biosciences, 2023, 1-9; of record); and Millipore Sigma (Millipore Sigma, 2025, 1); and Millipore Sigma C6288 (Millipore Sigma C6288, 2025, 1; of record).
The combined references of Stern and Baiersdorfer is withdrawn in favor of including a reference comprising additional specific amphipathic nanoparticles.
In view of the withdrawn rejections, Applicant’s arguments are rendered moot.
Maintained Objections/Rejections
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1, 4, 5, 11, 12, 14, 101 and 106 is maintained under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 is indefinite for the recitation of the term “much of the thickness” such as recited in claim 1, lines 22-23 and 30 because the term is a relative term that renders the claim indefinite. The term “much of” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite amount of the thickness of the first plate and/or the thickness of the second plate as compared to the total thickness, which qualifies as “much of the thickness” of a plate (e.g., a portion, 50%, 75%, 99%, etc.) such that one of ordinary skill in the art would not be reasonably appraised of the scope of the invention.
Claim 1 is indefinite for the recitation of the term “passing the RNA mixture through a fluid-permeable sponge” such as recited in claim 1, line 54 because although step (b) uses liquid reagents, steps (b)-(f) are not recited to take place within a fluid or solvent. Moreover, the RNA mixture is not recited to be dissolved in the one or more liquid reagents, solvent, buffer, etc., such that it is unclear how the RNA mixture can be passed through a liquid permeable sponge and, thus, the metes and bounds of the claim cannot be determined.
Claim 4 is indefinite for the recitation of the term “concentrating” such as recited in claim 4, lines 1-2 because claim 4 depends from instant claim 1, wherein claim 1 does not recite that the mRNA ‘therapeutic polynucleotide composition’ is within a solution and/or is dissolved in a solution, such that it is unclear what is being “concentrated” in a microfluidic process chip and, thus, the metes and bounds of the claim cannot be determined.
Claim 5 is indefinite for the recitation of the term “the obtained mRNA therapeutic polynucleotide composition” such as recited in claim 5, lines 1-2. There is insufficient antecedent basis for the term “the obtained mRNA therapeutic polynucleotide composition” in the claim because claim 1, line 51 recites the term “to form an mRNA therapeutic polynucleotide composition.” The Examiner suggests that Applicant amend the claim to recite, for example, “the mRNA therapeutic polynucleotide composition is designed.”
Claim 11 is indefinite for the recitation of the term “processing fluid pressure” such as recited in claim 11, line 4 because claim 11 depends from instant claim 1, wherein claim 1 does not recite the presence of a ‘processing fluid’ and/or any fluid within the system; and it is unclear how a “fluid pressure” is provided. Moreover, the term “processing fluid pressure” is not taught in the as-filed Specification, such that it is unclear how a “processing fluid pressure” is different from applying a “fluid pressure” and, thus, the metes and bounds of the claim cannot be determined.
Claim 106 is indefinite for the recitation of the term “sized and/or shaped to conform substantially to the volume of all or a portion of one or more second chamber portion” such as recited in claim 106, lines 2-3 because claim 106 depends from instant claim 1, wherein claim 1, lines 58-59 recite the term “the fluid permeable sponge spanning the second chamber portion…that the fluid permeable sponge is located within” such that the fluid permeable sponge of claim 1 is already sized and/or shaped to conform substantially to the volume of all or a portion of the one or more second chamber portions and, thus, the metes and bounds of the claim cannot be determined.
Claims 2, 12, 14 and 101 are indefinite insofar as they ultimately depend from instant claim 1.
Claim Rejections - 35 USC § 112(d)
The rejection of claim 11 is maintained, and claims 4 and 106 are newly rejected, under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends
Claim 4 recites (in part): “further comprising concentrating the mRNA therapeutic polynucleotide composition” in lines 1-2 because claim 4 depends from instant claim 1, wherein claim 1 does not recite that the mRNA ‘therapeutic polynucleotide composition’ is within a solution and/or is dissolved in a solution, and/or does not provide any component from which the composition is “concentrated” in a microfluidic process chip. Thus, claim 4 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites (in part): “transporting one or more reagents between the one or more fluid vials of the plurality of fluid vials and the plurality of second chamber portions by applying a processing fluid pressure to the sealed and closed fluidic path” in lines 1-4 because claim 11 depends from instant claim 1, wherein claim 1 does not recite the presence of a ‘processing fluid’ and/or any fluid in the system aside from liquid reagents. Thus, claim 11 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 106 recites (in part): “the fluid-permeable sponge being sized and/or shaped to conform substantially to the volume of all or a portion of at least one or more second chamber portion of the plurality of second chamber portions” in lines 1-3 because claim 106 depends from instant claim 1, wherein claim 1, lines 58-59 recites the term “the fluid permeable sponge spanning the second chamber portion…that the fluid permeable sponge is located within” such that the fluid permeable sponge of claim 1 is already sized and/or shaped to conform substantially to the volume of all or a portion of the one or more second chamber portions. Thus, claim 106 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 4, 5, 11, 12, 14, 101 and 106 is maintained under 35 U.S.C. 103 as being unpatentable over Stern et al. (hereinafter “Stern”) (US Patent Application Publication No. 20120164036, published June 28, 2012; of record) in view of Baiersdorfer et al. (hereinafter “Baiersdorfer”) (US Patent Application Publication 20190153425, published May 23, 2019; effective filing date April 22, 2016; of record) and further in view of Waymouth et al. (hereinafter “Waymouth”) (US Patent Application Publication No. 20180028688, filed July 27, 2017, published February 1, 2018; effective filing date July 27, 2016; of record) as evidenced by Jovanovich et al. (hereinafter “Jovanovich”) (US Patent Application Publication 20070248958, published October 25, 2007; of record); and Barbosa et al. (hereinafter “Barbosa”) (Bioresources, 2013, 8(1), 1043-1054; of record); and BpH (BiopHorectics, 2025, 1-2; of record); and Ziegenhals et al. (hereinafter “Ziegenhals”) (Frontiers in Molecular Biosciences, 2023, 1-9; of record); and Millipore Sigma (Millipore Sigma, 2025, 1); and Millipore Sigma C6288 (Millipore Sigma C6288, 2025, 1).
Regarding claims 1 (in part), 4, 5 (in part), 11, 12, 14, 101 and 106, Stern teaches that the invention provides for devices and methods for interfacing microchips to cartridges and pneumatic manifolds, wherein the design of the cartridges, microchips, and pneumatic manifolds can allow for the use of magnetic forces to capture magnetic beads in a chamber formed between the microchip and the cartridge, or a chamber within the microchip including for mRNA amplification and purification (interpreted as one or more microfluidic path devices; interpreting the beads, microchip, chamber and/or cartridge as fluid depots and/or reactors in a sealed and closed fluidic path; interpreting a manifold as a folded structure; interpreting mRNA as a single stranded therapeutic polynucleotide; and pneumatic transport, claims 1, 12 and 100) (Abstract). Stern teaches that the microfluidic chip can be constructed from any material known to those skilled in the art, wherein the fluidics and pneumatic layer are constructed from glass and the elastomeric layer is formed from PDMS and/or the elastomer can be replaced by a thin membrane of deformable material such as Teflon, silicon or other membrane (interpreting the insert membrane to comprise any membrane material including encompassing a cellulose membrane including carboxylate coating; interpreting a thin membrane as an impermeable sheet, claims 1, 101 and 108) (paragraph [0090]). Stern teaches that the Eberwine protocol has been streamlined and simplified by commercial vendors such as Ambion, such that as shown in FIG. 25, the Ambion procedure comprises three binary (two component) additions followed by an RNA purification process, wherein each binary addition can be followed by incubations at specific temperatures, such that the initial reverse transcription (RT) reaction can have three inputs (primer, total RNA, and reverse transcriptase [RT] Mix); however, total RNA and primer can conveniently be premixed; and that synthesized RNA can be labeled at this stage by incorporation of biotin labeled ribonucleotides (interpreting synthesized RNA as a forming synthetic dsDNA; manufacturing a polynucleotide; and purifying the polynucleotide, claim 1) (paragraph [0109], lines 1-10 and 15-17; and Figure 25). Stern teaches that Figure 27 illustrates the script for the three-step Eberwine chemistry, which is organized into three sections for Reverse Transcription (RT), Second Strand (SS) Synthesis, and In Vitro Transcription (IVT), wherein each section has in common three steps: (i) buffer priming, (ii) reaction mixing, and (iii) Fluorinert insertion (interpreting second strand synthesis as forming a synthetic template; IVT as transcription from the template to produce a polynucleotide; and encompassing a site of care, claims 1 and 14) (paragraph [0136], lines 1-6 and Figure 27). Stern teaches that priming removes air to ensure precise volume control of mixed solutions; while Fluorinert insertion, after mixing, elevates the reaction mixture into the pipette tip for best contact with the TEC-Tip Manifold, and also eliminates evaporation during extended incubations, such that any inert fluid can be used in place of Fluorinert (e.g., Fluorinert 77) including inert fluids of low viscosity (interpreting second strand synthesis as forming a synthetic template; and interpreting the removal of air as configured to be in fluid communication with one or more microfluidic path devices, and in a sealed and closed fluidic path protected from atmospheric contact, claim 1) (paragraph [0136], lines 6-13 and Figure 27). Stern teaches that the base further comprises a pneumatic floater that is positioned within the support structure that can be rigid, wherein the pneumatic floater can be supported by springs that allow for an air-tight seals between the pneumatic floater and the microfluidic chip; and the base can further comprise a pneumatic insert that is fluidically connected with the cartridge (interpreted as a permeable insert; pneumatic insert; configured to be secured in sealed fluid communication with one or more fluid path devices; a closed fluidic path protected from atmospheric contact; encompassing a site of care fluidly connected; applying pressure; deflection of the membrane; liquid permeable; folded structure; being sized and shaped; and pneumatic transportation of reagents, claims 1, 11, 12, 14,100, 105, and 106) (paragraph [0007]). Stern teaches that the reservoirs can be used as holding chambers, reaction chambers (e.g., that comprise reagents for carrying out a reaction), chambers for providing heating or cooling (e.g., that contain thermal control elements or that are thermally connected to thermal control devices), or separation chambers (e.g. paramagnetic bead separations, affinity capture matrices, or chromatography), and/or any type of chamber can be used in the devices described herein, e.g. those described in U.S. Patent Publication Number 2007/0248958 (Jovanovich) (interpreting a plurality of chambers and a plurality of reservoirs as a plurality of fluid vials; microfluidic path devices; fluid-contacting chamber sides; delivery vehicle; pressure receiving chamber sides; reactors; deformable membrane; fluidic channel on one side and a pressure chamber on the other side; and sealed and closed, claims 1, 4, 11, 12 and 106) (paragraphs [0061] and [0094]), wherein it is known that pneumatic displacement chamber formed by etching, where pressure can be applied to the membrane or close the valve by simple deformation of the flexible membrane as evidenced by Jovanovich (paragraph [0094]). Stern teaches in Figure 1 that tat the microfluidic chip (103) can be interfaced with a cartridge (101); the chip having a chamber (105), wherein the chamber can be used as a reaction chamber, a mixing chamber, or a capture chamber to capture magnetic particles such as magnetic beads, paramagnetic beads, solid phase extraction material, monoliths, or chromatography matrices (interpreting chips and cartridges as fluid depots in sealed communication with microfluidic path devices; chambers as reactors or fluid depots; and interpreting capture particles as encompassing amphipathic nanoparticles, claim 1) (paragraph [0080]). Stern teaches that on-chip valves can be used to pump reagents and samples to chambers and reservoirs in the cartridge and the microfluidic chip through channels (interpreting valves and channels as reactors for transporting reagent between fluid depots; reservoirs and chambers as fluid depots; transporting by fluid power; and pneumatic transport, claims 1, 11 and 12) (paragraph [0114]). Figure 1 is shown below:
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Figure 1
wherein the cartridge (101) comprises: a chip (103), a port (115), cartridge reservoir (107) (interpreted as a first chamber portion), cartridge reservoir opening (117), pneumatic manifold (113) (interpreted as comprising an elastic membrane, wherein pressure manipulates the membrane), microfluidic chamber (105), wherein the chamber can capture solid phase extraction materials or chromatography matrices (interpreting the chamber as a first chamber portion or a second chamber portion; and interpreting extraction or matrix materials as including cellulose), magnetic component (109), wherein other devices can be interfaced with the microfluidic chip including separation devices (interpreting an interfacing device as a second chamber portion) (paragraphs [0080]-[0082]; and Figure 1). Stern teaches that each of the steps can be carried out on the devices described herein; and that reagents and samples can be supplied through ports in the cartridge and then delivered to the microfluidic chip, such that on-chip valves can be used to pump the reagents and samples into chambers and reservoirs in the cartridge and the microfluidic chip through channels (interpreted as transporting and delivering samples including mRNA and a dsDNA template, claim 1) (paragraph [0014]). Stern teaches pneumatic inserts (FIG. 5), on their other (distal) sides that can provide for distal side connections that can allow air to escape or enter the incubation channels (which can be serpentine channels) as they are filled and emptied, respectively, or they can be used to supply positive pressure or vacuum to the channel (interpreted as fluid-contacting sides or pressure receiving chamber sides, claim 1) (paragraph [0073], lines 11-17). Stern teaches that detectors, separation devices such as gas chromatographs, capillary electrophoresis, mass spectrometers, etc; as well as, light sources, or temperature control devices can be positioned next to the microfluidic chip or used in conjunction with the microfluidic chip (interpreting the devices and chip to be a system and/or one or more microfluidic path devices, claim 1) (paragraph [0082]). Stern teaches that Figure 5 illustrates the Fluidic Manifold can comprise two parts: Reservoir and Reservoir Bottom, wherein the Reservoir can comprise a surface comprising channels or troughs, such that the Reservoir Bottom can serve to seal Reservoir channels and provides access holes (vias) to the attached chip; and that the chip can be attached to the bottom surface of the Fluidic Manifold with laser-cut pressure sensitive adhesive (interpreted as configured to be secured in sealed fluid communication with one or more fluid path devices; interpreting a reservoir as a fluid depot; and a closed fluidic path protected from atmospheric contact, claim 1) (paragraph [0073], lines 20-23; and Figures 5 and 7). Figures 5 and 7 are shown below:
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Figure 7
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Figure 5
Stern teaches that the target RNA can be relevant for many important clinical diagnostic applications analyzing samples containing few cells, such as samples derived from fine needle aspirates (FNA) or laser capture microdissection (LCM) (interpreted as encompassing sites of care, claim 14) (paragraph [0106], lines 25-28). Stern teaches the Figure 14 illustrates that the microfluidic chip (103) can be formed of a fluidics layer (203), an elastomeric layer (205), and a pneumatic layer (207), wherein the fluidics layer an contain features such as a chamber (105), as well as, channels, valves and ports, wherein the channels can be microfluidic channels used for the transfer of fluids between chambers and/or ports (interpreting the elastomer layer as an impermeable sheet, claim 101) (paragraph [0084], lines 1-5). Figure 14 is shown below:
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Stern teaches Figure 16, wherein the fluidic layer (203) can be constructed of one or more layers of material and/or two layers of material; and channels (301, 303, 305) can be formed at the interface between the two layers of material, and a chamber (105) can be formed by complete removal of a portion of one layer of material, such that the channels can have any shape, e.g., rounded and on one side (301), rectangular (303), or circular (305) (interpreted as an upper plate and a lower plate; and a plurality of chambers, claim 1) (paragraph [0087]; and Figure 16). Stern teaches the elastomer can be replaced by a thin membrane of deformable material such as Teflon, silicon or other membrane (interpreted as encompassing a cellulose membrane, claim 1) (paragraph [0090]). Stern teaches that after synthesis, amplified RNA (aRNA) can be purified to remove enzymes, buffers, salts, unincorporated nucleotides, pyrophosphate, etc., such that purification can rely on commercial kits exploiting the association of aRNA with silica membranes or beads (paragraph [0110]), wherein cellulose acetate (CA)/silica nanocomposite membranes are known in the art as evidenced by Najasi et al. (Abstract). Stern teaches that separation and cleanup can include solid phase reversible immobilization (SPRI), which utilizes a variety of chemistries and, wherein other chemistries include PEG/salt-driven association of nucleic acids with magnetic beads that can be covered with carboxylated polymers (interpreted as comprising a carboxylate coating, claim 108) (paragraph [0116]). Stern teaches pharmaceutically active peptides or proteins include a peptide that can be used in the treatment of a subject where the expression of a peptide would be of benefit, such as to ameliorate the symptoms of a disease or disorder (interpreted as an amphipathic nanoparticle; and peptoid including an amino-lipidated peptoid, claim 6) (paragraph [0159], lines 1-6). Stern teaches that one or more additional and/or supplementary active compounds can comprise an immuno-therapeutic agent inducing or effecting a targeted immune reaction, wherein immunotherapeutic agents include proteins or peptides (interpreted as encompassing amino-lipidated peptoids, claim 6) (paragraphs [0191], lines 1-4 and 13). Stern teaches that a cartridge can have reservoirs with volumes capable of holding nanoliters, microliters, milliliters, or liters of fluid (interpreted as sized to conform substantially to the volume of all or a portion of the fluid-contacting chamber size, claim 106) (paragraph [0061], lines 16-18). Stern teaches that the beads can be used to capture, concentrate, and then purify specific target antigens, proteins, carbohydrates, toxins, nucleic acids, cells, viruses, and spores, wherein the beads can have a specific affinity reagent, typically an antibody, aptamer, or DNA that binds to a target; that the beads can be added to complex samples such as aerosols, liquids, bodily fluids, extracts, or food; and that the purified and concentrated targets can be transported, denatured, lysed or analyzed while on-bead, or eluted off the bead for further sample preparation or analysis (interpreting beads as delivery vehicle; interpreting viruses to comprise dsRNA; DNA to encompass dsDNA; addition to bodily fluids, etc.; interpreting concentrating the target as concentrating the therapeutic polynucleotide; reverse transcription as forming a therapeutic polynucleotide composition; and interpreted as encompassing sites of care, claims 1 and 4) (paragraph [0117]). Stern teaches that Figure 27 shows the script for the three-step Eberwine chemistry is organized into three sections for reverse transcription (RT), second strand (SS) synthesis, and in vitro transcription (IVT), wherein each section has in common three steps including: (i) buffer priming, (ii) reaction mixing, and (iii) Fluorinert insertion (interpreting RT to product dsDNA; and IVT of viruses to comprise dsRNA, claim 1) (paragraph [0136], lines 1-6; and Figure 27), wherein it is known that dsRNA is a by-product of in vitro transcription as evidenced by Ziegenhals (Introduction). Stern teaches that the devices of the invention can accommodate the use of magnetic beads, such as by being supplied to a port of a cartridge, and pumped to desired chambers or reservoirs within the microfluidic device or cartridge (interpreting beads and chambers as reactors in a microfluidic path device; interpreting magnetic beads as delivery vehicles; and chambers and reservoirs as fluid depots, claims 1 and 4) (paragraph [0119]). Stern teaches that RNA-bead complexes are captured with a magnet, and the carboxylated SpeedBeads are washed with EtOH, dried, and RNA is eluted in a small volume of water (interpreted as transporting reagents; purifying an single-stranded polynucleotide; interpreting SpeedBeads as a delivery vehicle comprising a carboxylate, which is interpreted to be an amphipathic nanoparticle; and interpreting SpeedBeads as NTX-DV-0024, claims 1 and 4-6) (paragraphs [0116]), wherein it is known that carbonyl and carboxyl groups are important components of bleached cellulosic pulp as evidenced by Barbosa (Abstract, lines 1-2); as well as, the use of carboxymethyl cellulose for the separation of proteins and nucleic acids as evidenced by BpH (pg. 2). Stern teaches that the sample comprises RNA, wherein the RNA can be messenger RNA (mRNA) (interpreted as mRNA, claims 1 and 9) (paragraphs [0036]; [0106], lines 1-3 and 13; and Figures 19 and 24-26).
Stern does not specifically exemplify amphipathic nanoparticles (claim 1, in part); and that the mRNA therapeutic polynucleotide composition as being designed to transport mRNA polynucleotide to a human (claim 5, in part).
Regarding claim 1 (in part) and 5 (in part), Baiersdorfer teaches that it is important to remove dsRNA from the IVT mRNA that will be used as a therapeutic (paragraph [0002], lines 11-12). Baiersdorfer teaches a simple, fast, and cost-effective method of providing ssRNA in a yield and purity comparable to the ssRNA obtained by using HPLC, which does not affect long NRAs, and/or which does not degrade RNA (paragraph [0008]). Baiersdorfer teaches a method for providing ssRNA, comprising (i) providing an RNA preparation comprising ssRNA produced by in vitro transcription; (ii) contacting the RNA preparation with a cellulose material under conditions which allow binding of double-stranded RNA (dsRNA) to the cellulose material; and (iii) separating the ssRNA from the cellulose material under conditions which allow binding of dsRNA to the cellulose material to produce the RNA preparation comprising ssRNA by in vitro transcription (paragraphs [0009]-[0010]). Baiersdorfer teaches a negative purification procedure, in step (ii) and/or (iii) the mixture of the RNA preparation, the cellulose material, and the first buffer is provided in a tube and step (iii) comprises (1) applying gravity or centrifugal force to the tube such that the liquid and solid phases are separated; and (2) either collecting the supernatant comprising ssRNA or removing the cellulose material; or alternatively in step (ii) and/or (iii) the mixture of the RNA preparation, the cellulose material, and the first buffer is provided in a spin column or filter device and step (iii) comprises (1' applying gravity, centrifugal force, pressure, or vacuum to the spin column or filter device such that the liquid and solid phases are separated; and (2') collecting the flow through comprising ssRNA (interpreted as purifying by removing the dsRNA from the therapeutic polynucleotide using cellulose material, claim 1) (paragraph [0015]). Baiersdorfer teaches the positive purification procedure, step (ii) comprises (1) mixing the RNA preparation comprising ssRNA with the cellulose material under shaking and/or stirring; and (2) separating the cellulose material to which dsRNA and ssRNA are bound from the remainder (interpreted as purifying by removing the dsRNA from the therapeutic polynucleotide using cellulose material, claim 1) (paragraph [0017]). Baiersdorfer teaches cellulose purification of IVT RNA, wherein “cellulose material” includes any cellulose fibers, CF-11, cellulose powder, commercially available celluloses such as from Sigma-Aldrich and Macherey-Nagel (paragraphs [0029]; [0035]; and [0076]), wherein it is known that Sigma-Aldrich sells cellulose sponges and cellulose fibers as evidenced by Millipore Sigma (pg. 1) and Millipore Sigma C2688 (pg. 1). Baiersdorfer teaches that the purification method of Example 1 was adapted for using microcentrifuge spin columns to separate unbound RNA from cellulose, wherein the advantage of this technique is the complete removal of liquid and thus unbound RNA from cellulose by centrifugation (paragraph [0273], lines 1-6). Baiersdorfer teaches that IVT RNA contains dsRNA contaminants due to aberrant activity of T7 RNA polymerase, such that dsRNA induces inflammatory cytokines (such as interferon) by activating different cellular sensors, including RIG-I, MDA5 and TLR3, and also inhibits translation directly by activating protein kinase R (PKR) and oligoadenylate synthetase (OAS), wherein to test whether IVT RNA subjected to a method of the present invention induces less inflammatory cytokines and/or can be translated more efficiently compared to IVT RNA which has not been subjected to a method of the present invention (paragraph [0291], lines 1-11). Baiersdorfer teaches that excipients, particularly carriers, with which ssRNA can form complexes or form vesicles in which the ssRNA is enclosed or encapsulated, results in increased stability of the ssRNA compared to naked ssRNA, wherein excipients include lipid-containing carriers such as cationic lipids, liposomes, cationic liposomes, micelles and nanoparticles (interpreted as a delivery vehicle; an amphipathic nanoparticles; and an amino-lipidated peptoid, claims 1 and 5) (paragraph [0205], lines 1-10). Baiersdorfer teaches the administration of the active agent (i.e., the ssRNA of the invention and optionally one or more additional/supplementary active compounds) by certain routes of administration, where it can be necessary to coat the active agent with, or co-administer the compound with, a material to prevent its inactivation and/or to increase the effectiveness of the active agent (in particular the ssRNA of the invention) to be translated such that, for example, the active agent can be administered to an individual in an appropriate carrier, for example, lipid-containing carriers (in particular cationic lipids), liposomes such as water-in-oil-in-water CGF emulsions; as well as, conventional liposomes (Strejan et al., J. Neuroimmunol., 7: 27 (1984)), in particular cationic liposomes), micelles, nanoparticles in which the ssRNA is enclosed or encapsulated, or a diluent including pharmaceutically acceptable diluents include saline and aqueous buffered solutions (interpreted as an amphipathic nanoparticle; and an amino-lipidated peptoid, claim 1) (paragraph [0217]). Baiersdorfer teaches that the ssRNA and pharmaceutical compositions of the invention can be used in the treatment of a condition, disorder or disease including infectious disease, undesirable inflammation and/or cancer (paragraph [0176]). Baiersdorfer teaches in Figure 4, a comparison of the performance of different types of cellulose in removing dsRNA from IVT RNA, wherein the unbound and bound fractions of 100 μg of 1,500 nt-long m1 Y-modified IVT RNA after 1 cycle of purification using different celluloses, microcentrifuge spin columns and buffer containing 16% (v/v) EtOH were analyzed by dot blotting; and samples of 80 ng, 400 ng and 2,000 ng of RNA were analyzed for dsRNA contaminants using dsRNA specific antibody (paragraph [0281]). Baiersdorfer teaches analyzing the impact of the buffer’s ionic strength on the efficiency of dsRNA removal by cellulose (interpreted as removing dsRNA) (paragraph [0283]). Baiersdorfer teaches a pharmaceutical composition comprising such ssRNA optionally together with a pharmaceutically acceptable excipient for use in a method of treating a condition, disorder or disease as specified herein including cancer (interpreting binding RNA to cellulose material as formulating the therapeutic polynucleotide with a delivery vehicle, claim 1) (paragraphs [0024] and [0177]). Baiersdorfer teaches a positive purification procedure, where in step (ii) the cellulose material is provided in a column; step (ii) comprises loading the RNA preparation onto the column under conditions which allow binding of dsRNA and ssRNA to the cellulose material, and in step (ii) the RNA preparation is provided and loaded onto the column as a liquid comprising ssRNA and a second buffer, wherein the second buffer comprises water, ethanol and a salt, preferably sodium chloride, in a concentration which allows binding of dsRNA and ssRNA to the cellulose material; and step (iii) comprises eluting the ssRNA from the cellulose material under conditions which allow binding of dsRNA to the cellulose material and do not allow binding of ssRNA to the cellulose material; (interpreted as purifying the RNA using cellulose material; and formulating the therapeutic polynucleotide with a delivery vehicle, claim 1) (paragraph [0024]). Baiersdorfer teaches that ssRNA or pharmaceutical compositions of the invention cross the BBB (if desired) can be formulated, for example, in liposomes, such that for methods of manufacturing liposomes, see, e.g., U.S. Pat. Nos. 4,522,811; 5,374,548; and 5,399,331, wherein the liposomes can comprise one or more moieties which are selectively transported into specific cells or organs, and thus enhance targeted drug delivery (interpreting formulating ssRNA in liposomes as formulating a polynucleotide for delivery to a target tissue; and designed to be transported to a target tissue, claims 1 and 5) (paragraph [0230]). Baiersdorfer teaches that prior to step (ii), the RNA preparation is subjected to at least one purification treatment including binding the nucleic acids to magnetic beads (interpreting magnetic beads as formulating the therapeutic polynucleotide with a delivery vehicle, claim 1) (paragraph [0026]).
The combined references of Stern and Baiersdorfer do not specifically exemplify additional amphipathic nanoparticles; and transport mRNA polynucleotide to a human (claim 5, in part).
Regarding claims 1 (in part), Waymouth teaches complexes, compositions and methods for the delivery of therapeutic, diagnostic and imaging agents including nucleic acid, into a cell, wherein the complexes, compositions and methods may facilitate complexation, protection, delivery and release of oligonucleotides and polyanionic cargos into target cells, tissues, and organs both in vitro and in vivo including to a human (interpreted as being designed for delivery to a target tissue in a human, claim 5) (Abstract; and paragraph [0125]). Waymouth teaches nanoparticle compositions including a plurality of cell-penetrating complexes including cationic amphipathic polymers of the formula H-L1[(LP1)z1-(IM)z2-(LP2)z3]z4-L2-H, wherein L1 and L2 are independently a bond or a lipophilic polymer domain; IM is the pH-sensitive immolation domain; z1, z3 and z4 are independently integers from 0 to 100, wherein at least one of z1 or z3 is not 0; and z2 is an integer from 2 to 100; and L1 can be a peptide (e.g., an amino acid sequence), wherein the term “lipophilic polymer domain”, often referred to as “lipid block”, refers to a region of the cationic amphipathic polymer that is not hydrophilic, such that the lipophilic polymer domain can have low solubility in water (interpreted as encompassing amino amphipathic nanoparticles; designed to be delivered to tissues and organs; and amino-lipidated peptoid nanoparticles, claim 5) (paragraphs [0006]-[0007]; and [0113]). Waymouth teaches in Figures 5A and 5B, data illustrating in situ vaccination using CARTs and mRNA coding for immunostimulatory protein (paragraph [0016]; and Figure 5). Waymouth teaches that Figure 6 illustrates charge-alternating releasable transporters (CARTs) for RNA delivery (paragraph [0017]; and Figure 6). Figure 6 is shown below:
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Figure 6
Waymouth teaches that the term "amphipathic polymer" refers to a polymer containing both hydrophilic and hydrophobic portions, wherein the hydrophilic to hydrophobic portions are present in a 1 to 1 mass ratio, 1 to 2 mass ratio, 1 to 5 mass ratio, 5 to 1 mass ratio, etc. (interpreted as an amphipathic nanoparticle, claims 1, 5 and 6) (paragraph [0112]). Waymouth teaches that gene delivery is achieved by formulation of the mixed amphipathic oligomer with an mRNA cargo in the presence of third components selected to tune stability and size of the resulting complex, increase cellular uptake, tune rate of mRNA release from the complex, and enhance expression of the cargo mRNA, wherein tertiary components including coordinating metals, dynamic non-covalent crosslinkers, and solubility modulators such as lipids and PEGs (interpreted as encompassing amino amphipathic nanoparticles; and amino-lipidated peptoid nanoparticles, claim 5) (paragraph [0286]). Waymouth teaches that the methods of the invention can treat and/or prevent a disease or condition using a cell-penetrating complex (paragraph [0315]). Waymouth teaches regenerated cellulose dialysis membranes (interpreted as cellulose membranes, claim 1) (paragraph [0353], lines 18-19). Waymouth teaches acceptable pharmaceutical compositions including carboxymethylcellulose, methyl cellulose, and ethyl cellulose (interpreted as celluloses, claim 1) (paragraph [0333]).
It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of delivering therapeutic, diagnostic and/or imaging agents including nucleic acids into a cell as exemplified by Waymouth, it would have been prima facie obvious before the effective filing date of the claimed invention to modify the method of producing RNA-bead complexes including producing RNA for important clinical diagnostic applications via microfluidic systems as disclosed by Stern to include methods of removing dsRNA from the IVT mRNA IVT as taught by Baiersdorfer, and the methods of synthesizing amphipathic nanoparticles and/or amphipathic nanoparticle compositions as taught by Waymouth with a reasonable expectation of success in the fast, efficient and cost-effective removal of contaminating dsRNA and RNA/DNA hybrids from the mRNA IVT before the production of a polynucleotide therapeutic including the production of a plurality of cell-penetrating complexes; in complexing, delivering and/or releasing purified oligonucleotides and polyanionic cargos into target cells, tissues, and organs both in vitro and in vivo; and/or in tuning the stability and size of the complex to increase cellular uptake of RNA or RNA-bead complexes, to tune the rate of mRNA release from the complex, and/or to enhance the expression of the cargo mRNA. It would have been prima facie obvious because Stern teaches the microfluidic preparation of mRNA and/or mRNA-bead complexes including complexes that can be added to complex samples such as aerosols, liquids, bodily fluids, extracts or food before or after binding to target material including for the detection of microorganisms in food, bodily fluids, and other matrices; as well as, for analyzing samples containing a few cells. Baiersdorfer teaches the simple, fast, and cost-effective method of removing transcriptional by-products including dsRNA from an IVT mixture by of contacting the mixture with cellulose materials. Waymouth teaches nanoparticle compositions including cell-penetrating complexes including cationic amphipathic polymer complexes for the delivery of therapeutic, diagnostic and imaging agents including nucleic acids into target cells, tissues, and/or organs for the treatment and/or prevention of a disease or condition, wherein cells include bacterial cells, viral cells, fungal cell, and pathogenic microbial agents. Thus, it would be prima facie obvious to use the nanoparticle compositions taught by Waymouth, wherein the mRNA is prepared in the devices exemplified by Stern, and purifying the mRNA using the methods and cellulose materials as taught by Baiersdorfer to deliver purified mRNA or mRNA-bead complexes such as nanoparticle compositions including a plurality of cell-penetrating complexes such as cationic amphipathic polymers into target cells including into human cells and/or into pathogenic microbial cells for the treatment or detection of disease and/or infection.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly rejected under 35 USC §103 as obvious over the art.
Response to Arguments
Applicant’s arguments filed March 31, 2026 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) Applicant has amended independent claim 1 to clarify at least one distinction between the claimed subject matter and the cited references, as noted above. None of the cited references, alone or in combination, teach the claimed method (Applicant Remarks, pg. 12, third and fourth full paragraphs).
Regarding (a), Applicant did not distinctly and specifically point out the supposed errors in the Examiner’s action as required by 37 CFR 1.111(b). Thus, the claims remain rejected for the reasons already of record.
New Objections/Rejections
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 1, 4, 5, 11, 12, 14, 101 and 106 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over: claims 86-100 of copending US Patent Application No. 19/228,087.
US19/228,087 teaches: a method comprising: communicating a first template to a process chip, the first template being located in a first well of a first tray; communicating a first set of one or more reagents to the process chip; performing in vitro transcription (IVT) utilizing the first template and the first set of one or more reagents, thereby creating a first RNA solution; communicating the first RNA solution to a first well of a second tray; communicating a second template to the process chip, the second template being located in a second well of the first tray; communicating a second set of one or more reagents to the process chip; performing in vitro transcription (IVT) utilizing the second template and the second set of one or more reagents, thereby creating a second RNA solution; and communicating the second RNA solution to a second well of the second tray (claim 86).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims encompass a method of carrying out IVT on at least one microfluidic process chip.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 4, 5, 11, 12, 14, 101 and 106 are rejected.
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/AMY M BUNKER/Primary Examiner, Art Unit 1684