Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/09/2025 has been entered.
Response to Arguments
Applicant’s arguments, filed 12/09/25, with respect to the rejection(s) of claim(s) under 35 USC 112 have been fully considered and are persuasive in light of the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration and because of the broadening of the claim limitations, a new ground(s) of rejection is made under 35 USC 112 and 35 USC 103 as unpatentable over Trainer in view of Bergh as explained below.
Claim Objections
Claim 81 is objected to because of the following informalities: line 17 currently reads “based the captured light scattering data”. The examiner believes this to be a typo and is missing the word “on” such that the limitation reads “based on the captured light scattering data.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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 81-89 and 125 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the fluid chamber and the mixing assemblies. Both the fluid chamber and the mixing assemblies are part of the process chip. The fluid chamber is described structurally in relationship to the dynamic light scattering assembly, a fluid chamber inlet, a fluid chamber outlet, a first fluid and a second fluid. The process chip further comprises a plurality of mixing assemblies with a plurality of inlets and outlets and a fluid input manifold. However the mixing assemblies, plurality of inlets and outlets, and fluid input manifold are not structurally related to the fluid chamber or dynamic light scattering assembly. There is no suggestion or understanding that the two different components are fluidically connected such that they are essentially two different inventions existing on the same process chip. Clarification is required.
Claim 81, line 11-12 discloses receiving light scatter by particles in response to “a first optical fiber emitting light” however fails to disclose an optical fiber that actually emits light into the fluid chamber and instead discloses a dynamic light scattering assembly the directs light into the chamber. There is no optical fiber. It is unclear if there is both an optical fiber and the dynamic light scattering assembly emitting light into the chamber or if they are otherwise connected or equivalent. Correction is required.
Claim 105 is unclear. The claim discloses the first fluid component containing mRNA encapsulated in a delivery vehicle. However, the specification only discloses the mRNA in a first fluid and the delivery vehicle in the second fluid (P.0129, P.0176, P.0227) and fails to disclose having both the mRNA and delivery vehicle in the first fluid together. It is unclear at which point the claim limitation refers to the first fluid: if it refers to the first fluid alone or once the first fluid is mixed with the second fluid. Clarification is required.
The balance of claims dependent upon claim 81 are likewise rejected for failing to correct the deficiency described above.
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.
Claim(s) 81-90, 102, 103, 104, 105, 106, 107, 123, and 125 are rejected under 35 U.S.C. 103 as being unpatentable over Trainer U.S. Publication 2008/0208511 in view of Bergh et al. U.S. Patent #7,150,994.
With respect to claim 81, Trainer discloses an apparatus for determining particle characteristics comprising:
A fluid chamber, the fluid chamber including a fluid chamber inlet and a fluid chamber outlet (Figure 55, fluid chamber = particle dispersion conduit, inlet = bottom, outlet is at the top)
An optically transmissive material adjacent to the fluid chamber (The sample cell is made of optically transmissive material, P.0136, windows for the cell)
A dynamic light scattering assembly, the process chip being configured to be removably positioned in relation to the dynamic light scattering assembly, the dynamic light scattering assembly being configured to direct the light through the optically transmissive material and into the fluid chamber, the dynamic light scattering assembly further being configured to receive light scattered by particles in fluid in the fluid chamber in response to a first optical fiber emitting light into the fluid chamber (P.0071, P.0136, dynamic light scattering assembly = dynamic light scattering system, P.0278, P.0340,
A processor being configured to determine one or both of size and size distribution of particles in the fluid based the captured light scattering data (P.0178, P.0206, P.0167, processor = computer)
The fluid chamber being configured to receive a first fluid and a second fluid, the second fluid including a particle containing solution having a known size (P.0209, P.0269, P.0295, first fluid = unknown particles, second fluid = particles of known size)
However, Trainer fails to disclose the structure of the process chip.
Bergh et al. discloses a parallel flow process optimization reactor comprising:
The process chip further comprising a plurality of mixing assemblies, each mixing assembly of the plurality of mixing assemblies having a plurality of inlets and an outlet, each mixing assembly of the plurality of mixing assemblies being configured to form a mixture of fluid from the plurality of inlets and communicate the mixture through the outlets (Figure 4B, Col.19, l 22-Col.20, l 41, mixing assemblies = mixing zones 540, inlets = 541, outlet = 545)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the combined feed control subsystem of Bergh for the input particle flow of Trainer since it provides flexibility for variably controlling output compositions (Col.20, l 42-51) in order to optimize chemical reactions involving multiple variables (Col.2, l 27-50).
With respect to claim 82, Trainer in view of Bergh discloses all of the limitations as applied to claim 81 above. However, Trainer fails to disclose the fluid chamber to receive a first fluid from a first channel and a second fluid from a second channel.
Bergh discloses a device for a parallel flow process reactor comprising:
a first fluid in a first channel and a second fluid in a second channel (Figure 4B, first fluid = Variable PP Reactants, first channel = 530, second fluid = Make-Up Gas, second channel 534)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the first and second channels as in Bergh to supply a particle sample to the measurement of Trainer since having variable inputs allows for a broader use of the particle measurement of Trainer. Being able to adjust and vary the inputs makes the measurement of Trainer more useful, saving money by using a single device for many different measurements.
With respect to claims 83, 84, 85, Trainer in view of Bergh disclose all of the limitations as applied to claim 82 above. In addition, the first fluid is not part of the claimed apparatus and the makeup of that fluid cannot structurally differentiate the apparatus.
With respect to claim 86, 87, Trainer in view of Bergh disclose all of the limitations as applied to claim 82 above. In addition, Trainer discloses:
The second fluid including at least some of the particles (P.0269, second fluid = mono-sized particles of known size)
The particles of the second fluid including beads (P.0269, beads = mono-sized particles of known size, there is no technical definition of beads)
With respect to claims 88, 89, 90, and 123, Trainer in view of Bergh disclose all of the limitations as applied to claim 87 above. In addition, the first fluid is not part of the claimed apparatus and the make-up of that fluid cannot structurally differentiate the apparatus.
With respect to claim 102, Trainer discloses a method for determining particle sizes comprising:
Communicating a fluid mixture through a process chip, the fluid mixture including particles (Figure 5, process chip = sample cell with spherical cavity, P.0132, P.0136 “flowing particle dispersion” and “particles passing through the cell”)
Emitting light toward the fluid mixture via a first optical fiber, the particles in the fluid mixture scattering the emitted light (Figure 5, light = light source, P.0136, P.0151, P.0383)
Receiving the light scattered from the particles in the fluid mixture, the received light being received by a second optical fiber obliquely oriented relative to the first optical fiber, the first and second optical fibers being secured to a body positioned near the process chip (P.0136, P.0151, Figure 5, wherein it is inherent that all elements are secured in a way as to make them fixed with respect to each other)
Performing autocorrelation on the received light (P.0262, P.0438)
Determining either a size of the particles in the fluid mixture using at least the autocorrelation (P.0262, P.0438)
Using a second fluid component including a particle containing solution with particles of known size (P.0269, mono-sized particles of known size)
However, Trainer fails to disclose the details with respect to communicating the fluid through the process chip.
Bergh et al. discloses a parallel flow process optimization method comprising:
Communicating fluid through a process chip including communicating a first fluid component through fluid input port to a fluid input manifold channel to thereby communicate the first fluid component to a first mixing assembly that is fluidically coupled with the fluid input manifold channel (Figure 4B, process chip = 525 feed control subsystem, first fluid component = make-up gas, fluid input port = 485, fluid input manifold channel = 534, first mixing assembly = first mixing zone 540)
The fluid input manifold channel also being fluidically coupled to a second mixing assembly, the first fluid component including at least some of the particles (Figure 4B, second mixing assembly = second mixing zone 540, Col.17, l 30-33, particles = molecules)
Communicating a second fluid component to the first mixing assembly and mixing the first and second fluid components together to form a fluid mixture (Figure 4B, Col.19, l 22-Col.20, l 41, mixing assemblies = mixing zones 540, inlets = 541, outlet = 545)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the combined feed control subsystem of Bergh for the input particle flow of Trainer since it provides flexibility for variably controlling output compositions (Col.20, l 42-51) in order to optimize chemical reactions involving multiple variables (Col.2, l 27-50).
With respect to claim 106 and 107, Trainer in view of Bergh discloses all of the limitations as applied to claim 102 above. In addition Trainer discloses:
The second fluid component including at least some particles (P.0269, mono-sized particles of known size)
The particles including beads (P.0269, mono-sized particles = beads)
With respect to claim 125, Trainer discloses an apparatus for determining particle characteristics comprising:
A process chip including a fluid chamber, the fluid chamber including a fluid chamber inlet and a fluid chamber outlet (Figure 55, fluid chamber = particle dispersion conduit, inlet = bottom, outlet is at the top, process chip = distribution system)
An optically transmissive material adjacent to the fluid chamber (The sample cell is made of optically transmissive material, P.0136, windows for the cell)
A dynamic light scattering assembly, the process chip being configured to be removably positioned in relation to the dynamic light scattering assembly, the dynamic light scattering assembly being configured to direct the light through the optically transmissive material and into the fluid chamber, the dynamic light scattering assembly further being configured to receive light scattered by particles in fluid in the fluid chamber in response to a first optical fiber emitting light into the fluid chamber (P.0071, P.0136, dynamic light scattering assembly = dynamic light scattering system, P.0278, P.0340,
A processor being configured to determine one or both of size and size distribution of particles in the fluid based the captured light scattering data (P.0178, P.0206, P.0167, processor = computer)
The fluid chamber being configured to receive a first fluid and a second fluid, the second fluid including a particle containing solution having a known size (P.0209, P.0269, P.0295, first fluid = unknown particles, second fluid = particles of known size)
The apparatus further comprising the second fluid (P.0295, second fluid is within the device)
However, Trainer fails to disclose the structure of the process chip.
Bergh et al. discloses a parallel flow process optimization reactor comprising:
The process chip further comprising a plurality of mixing assemblies, each mixing assembly of the plurality of mixing assemblies having a plurality of inlets and an outlet, each mixing assembly of the plurality of mixing assemblies being configured to form a mixture of fluid from the plurality of inlets and communicate the mixture through the outlets (Figure 4B, Col.19, l 22-Col.20, l 41, mixing assemblies = mixing zones 540, inlets = 541, outlet = 545)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the combined feed control subsystem of Bergh for the input particle flow of Trainer since it provides flexibility for variably controlling output compositions (Col.20, l 42-51) in order to optimize chemical reactions involving multiple variables (Col.2, l 27-50).
With respect to claims 103, 104, and 105, Trainer in view of Bergh discloses all of the limitations as applied to claim 102 above. However, Trainer and Bergh fail to disclose the first fluid including mRNA encapsulated with a delivery vehicle.
It would have been obvious to one of ordinary skill in the art at the time of the invention to measure particles of mRNA as the particles in Trainer and one of the fluids in Bergh since measuring mRNA is necessary for therapeutic treatments and analysis. Measuring mRNA particles is well known in the art as exampled by U.S. Patent #7,312,085 and U.S. Patent #8,658,418. Additionally, the examiner takes official notice that it is well known to transport the mRNA particles encapsulated in a delivery vehicle since the mRNA are generally too small for analysis.
Citation
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bott U.S. Patent #4,676,641 discloses a system for measuring size distribution of particles in a fluid
Marshall et al. U.S. Publication 2018/0059005 discloses a microfluidic mixer method for particle bearing fluids
Kornilovich et al. U.S. Patent #9,963,739 discloses a polymerase chain reaction system
Ramsay et al. U.S. Patent #11,938,454 discloses a microfluidic system
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA CAROLE BRYANT whose telephone number is (571)272-9787. The examiner can normally be reached M-F, 12-4 pm.
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/REBECCA C BRYANT/ Primary Examiner, Art Unit 2877