DETAILED ACTION
In application filed on 10/13/2023, Claims 1-6, 13-15, 17-19, 23, 25-26, 28, and 72-73, 81 and 122 are pending. The claim set submitted on 06/01/2026 is considered because this is the most recent claim set with some preliminary amendments. Claims 1-6, 13-15, 17-19, 23, 25-26, 28, 72 and 73 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/13/2023, 06/01/2026 and 06/24/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 06/01/2026 is acknowledged. Claims 81 and 122 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/01/2026.
Group I, Claims 1-6, 13-15, 17-19, 23, 25-26, 28, and 72-73, 81 and 122 are considered on the merits below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 25-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to statutory categories, i.e., apparatus (Claim 25-26) (Step 1: YES).
Analysis:
Claim 25: Ineligible.
Step 1:
The claim recites a series of steps or acts, including “an apparatus”. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1: YES).
Step 2A, Prong 1:
Claim 25 recites “…a processor, the processor to determine one or both of sizes of particles in fluid in the fluid chamber using at least data from the dynamic light scattering assembly or size distribution of particles in fluid in the fluid chamber using at least data from the dynamic light scattering assembly”. Therefore, the claim is directed towards an abstract idea, and more specifically to the abstract idea group of a math or mental process since claim 25 relates to using a math process to perform the steps reciting the abstract ideas.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites ‘additional elements’ which are the steps performed before and after the recited abstract ideas. However, the steps before the abstract ideas are performed in order to gather data necessary to perform the determination step. Thus, these steps do not add a meaningful limitation since these steps are insignificant pre-solution activity.
Once the determination is done, no further action takes place. Also, the claim recites a processor which is part of a computer and a general purpose computer is not a particular machine – MPEP 2106.05(b) I.
Accordingly, these steps are ‘additional elements’ which do not integrate the abstract ideas into a practical application because they do not impose meaningful limits on practicing the abstract ideas (Step 2A, Prong Two: NO).
Step 2B:
Furthermore, the courts have found that limitations adding insignificant extrasolution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see the 2014 Interim Guidance on Patent Subject Matter Eligibility of the Federal Register dated December 16, 2014; and MPEP 2106.05(I)(A)). Note that mere data gathering is not significantly more than the abstract idea. See MPEP 2106.05(g).
Here, there are no additional elements which are significantly more than the abstract idea in dependent Claim 25. The “apparatus”, from the background section of the claim 1, appear well-understood, routine, and conventional (WURC) in the field of laboratory diagnostics, as evidenced by Deutsch et al. (US20210040472A1, submitted in IDS on 10/13/2023) in view of Ansari et al. (US20020180972A1, submitted in IDS on 10/13/2023).
, (See (Step 2B: NO).
Therefore, Claim 25 is ineligible.
Moreover, Claim 26 is rejected by virtue of their dependency on Claim 25 and the limitations of Claim 26 do not solve the issues of Claim 25.
Claim 26: Ineligible.
Step 2A, Prong One and Prong Two: Claims 26 further define the abstract idea reciting a mental or math step.
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claim 26 is ineligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-5, 13-15, 18-19, 23, 25-26 and 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Deutsch et al. (US20210040472A1, submitted in IDS on 10/13/2023) in view of Ansari et al. (US20020180972A1, submitted in IDS on 10/13/2023).
Regarding Claim 1, Deutsch teaches an apparatus comprising:
a process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]), the process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]) including:
a first exterior surface (referred to as first surface [Para 0235; Fig. 4, ref. 411]),
a second exterior surface (referred to as first surface [Para 0236; Fig. 4, ref. 433]),
a fluid chamber (referred to as fluid channel [Para 0236; Fig. 4, ref. 421]) positioned between (See Fig. 4) the first exterior surface (referred to as first surface [Para 0235; Fig. 4, ref. 411]) and the second exterior surface (referred to as first surface [Para 0236; Fig. 4, ref. 433]), the fluid chamber (referred to as fluid channel [Fig. 4, ref. 421]) including a fluid chamber inlet (referred to as fluid channel opening [Para 0237; Fig. 4, ref. 425]) and a fluid chamber outlet (referred to as an exit channel extending from the liquid containing side 417 ; See Para 0240… an exit channel may deliver fluid from the one or more chamber through another fluid port (not shown)]), and
an optically transmissive material (See Para 0217…The microfluidic path devices described herein may generally be at least partially transparent, and in particular, may be transparent on the top of the microfluidic path device,) positioned between the first exterior surface (referred to as first surface [Para 0235; Fig. 4, ref. 411]) and the fluid chamber (referred to as fluid channel [Para 0236; Fig. 4, ref. 421]); and
a dynamic light scattering assembly (See Para 0290…The resulting nanoparticles may be analyzed on the microfluidic path device (e.g., by the microfluidic path device control system) for size distribution using, e.g., Dynamic Light Scattering (DLS)), the process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]) to be removably positioned in relation to the dynamic light scattering assembly (See Para 0290…The resulting nanoparticles may be analyzed on the microfluidic path device (e.g., by the microfluidic path device control system) for size distribution using, e.g., Dynamic Light Scattering (DLS)), the process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]), the dynamic light scattering assembly (See Para 0290… e.g., by the microfluidic path device control system) for size distribution using, e.g., Dynamic Light Scattering (DLS)) includes:
a body (referred to as second plate [Fig. 4, ref. 405]), the body (referred to as second plate [Fig. 4, ref. 405]) including a first port (referred to as fluid port [Fig. 4, ref. 423]) and a second port (referred to as pressure port [Fig. 4, ref. 443]), the body to be positioned proximate (See Fig. 4) to the first exterior surface (referred to as first surface [Para 0235; Fig. 4, ref. 411]),
the process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]) to form particles including encapsulated nucleotides (See Para 0010…encapsulating the therapeutic mRNA with a delivery vehicle to form a therapeutic mRNA composition;See Para 0301… The nucleic acid mix may be encapsulated into 200 nm ANPs).
Deutsch does not teach the dynamic light scattering assembly including:
a first optical fiber coupled with the first port of the body, the first optical fiber to emit light, the first port to direct the light emitted by the first optical fiber through the optically transmissive material and into the fluid chamber, and
a second optical fiber coupled with the second port of the body, the second optical fiber at the second port being oriented obliquely relative to the first optical fiber at the first port, the second optical fiber to receive light scattered by particles in fluid in the fluid chamber in response to the first optical fiber emitting light into the fluid chamber.
In the analogous art of dynamic light scattering (DLS) being disclosed for the use in accurately and reliably determining the size and/or size distribution of microscopic particles in laminar or turbulent flow, Ansari teaches that the dynamic light scattering assembly (See Para 0013; Figs. 1-3, ref. 14…DLS system) including:
a first optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]) coupled (See Fig. 3) with the first port (See Annotated Fig. 3) of the body (See Annotated Fig. 3) , the first optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]) to emit light (See Para 0023…the laser launching optics…integrated into a small probe using the fiber optics technology (fiber optic DLS probe).. .coherent light from the laser is launched into one end of transmitting fiber), the first port (See Annotated Fig. 3) to direct the light emitted by the first optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]) coupled (See Fig. 3) through the optically transmissive material (See Para 0008…glass is optical transmissive) and into the fluid chamber (See Annotated Fig. 3), and
a second optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]) coupled (See Fig. 3) with the second port (See Annotated Fig. 3) of the body (See Annotated Fig. 3), the second optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]) at the second port (See Annotated Fig. 3) being oriented obliquely relative (See Para 0021…Also shown in FIG. 1, the laser and detector set-up can be positioned in different ways with respect to direction of flows—away from the flowing direction (Position A), parallel to the flow direction (Position B), or facing or perpendicular to the flow direction (Position C)) to the first optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]) at the first port (See Annotated Fig. 3), the second optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]) to receive light scattered by particles in fluid (See Para 0022…the detector has a focusing lens assembly (detector FLA) attached in the front in order to collect the scattered light from the focused illumination of the flowing particles. ) in the fluid chamber (See Annotated Fig. 3) in response to the first optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]) emitting light into the fluid chamber (See Annotated Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process chip of Deutsch to include that the dynamic light scattering assembly including: a first optical fiber coupled with the first port of the body, the first optical fiber to emit light, the first port to direct the light emitted by the first optical fiber through the optically transmissive material and into the fluid chamber, and a second optical fiber coupled with the second port of the body, the second optical fiber at the second port being oriented obliquely relative to the first optical fiber at the first port, the second optical fiber to receive light scattered by particles in fluid in the fluid chamber in response to the first optical fiber emitting light into the fluid chamber”, as taught by Ansari for the benefit of using the technique of DLS to accurately and reliably characterize the particles in flow. The present invention contemplates the use of DLS for accurate characterization of particle size and related information while the particles under study are in flow (Ansari, Para 0006), allowing for the provision of the technique of DLS can be used to accurately and reliably measure the size of the particles in flow. The present invention enables true real-time, on line, non-invasive monitoring, and characterization, especially in the field of materials processing, emulsions, colloidal engineering, product quality monitoring, quality monitoring of water and water treatment and other industrial processes. The present invention will also enable the real-time accurate characterization of biological fluid in flow (e.g., blood, biological cells, etc.) (Ansari, Abstract).
In addition, Claim 1 recites a process chip and a dynamic light scattering assembly chiller and then recites how these structures function. Claim 1 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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Annotated Fig. 2, Ansari
Regarding Claim 2, the apparatus of claim 1 is obvious over Deutsch in view of Ansari.
Deutsch further teaches that the fluid chamber (referred to as fluid channel [Para 0236; Fig. 4, ref. 421]) having a cylindraceous shape (See Fig. 4…Under BRI, the fluid channel as a cylindraceous shape) with a circular upper interior surface (See Fig. 4…Under BRI, the fluid channel as a circular upper interior surface), a circular lower interior surface (See Fig. 4…Under BRI, the fluid channel as a circular lower interior surface), and an interior sidewall (See Fig. 4…Under BRI, the fluid channel as an interior sidewall) extending from the circular upper interior surface (See Fig. 4…Under BRI, the fluid channel as a circular upper interior surface) to the circular lower interior surface (See Fig. 4…Under BRI, the fluid channel as a circular lower interior surface).
In addition, Examiner submits that the claimed “a cylindraceous shape” is not specifically defined in the specification and will therefore be given the broadest reasonable interpretation in light of the specification. Any shape that has a rounded, cylindrical or tubular or pipe shape will be considered a “a cylindraceous shape”. As such, the shape of the fluid channel where the fluid channel opening has a diameter would satisfy “a cylindraceous shape”.
Regarding Claim 3, the apparatus of claim 2 is obvious over Deutsch in view of Ansari. Deutsch further teaches that the fluid chamber inlet (referred to as fluid channel opening [Para 0237; Fig. 4, ref. 425]) being positioned in a region of the interior sidewall (See Fig. 4…Under BRI, the fluid channel as an interior sidewall, which has a region) near the circular lower interior surface (See Fig. 4…Under BRI, the fluid channel as a circular lower interior surface).
Regarding Claim 4, the apparatus of claim 2 is obvious over Deutsch in view of Ansari. Deutsch further teaches that the fluid chamber outlet (referred to as an exit channel extending from the liquid containing side 417 ; See Para 0240… an exit channel may deliver fluid from the one or more chamber through another fluid port (not shown)]) being positioned in a region of the interior sidewall (See Fig. 4…Under BRI, the fluid channel as an interior sidewall, which has a region) near the circular upper interior surface (See Fig. 4…Under BRI, the fluid channel as a circular upper interior surface).
Regarding Claim 5, the apparatus of claim 1 is obvious over Deutsch in view of Ansari.
Deutsch teaches that the process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]) further comprising a first mixing stage (referred to as chamber [Para 0236; Fig. 4, ref. 415] of the plurality of chambers [Para 0133]), the first mixing stage (referred to as chamber [Para 0236; Fig. 4, ref. 415]) to mix a first plurality of fluid components (See Para 0286…DV/mRNA mixing) to form a first fluid mixture (See Para 0242…the chambers within the microfluidic path device may be configured as mixing chambers, for mixing fluid within the microfluidic path device.), the fluid chamber inlet (referred to as fluid channel opening [Para 0237; Fig. 4, ref. 425]) to receive the first fluid mixture (See Para 0242…the chambers within the microfluidic path device may be configured as mixing chambers, for mixing fluid within the microfluidic path device.).
In addition, Claim 5 recites a process chip and then recites how the process chip function. Claim 5 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 13, the apparatus of claim 5 is obvious over Deutsch in view of Ansari.
Deutsch teaches that the process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]) further comprising a second mixing stage (referred to as chamber [Para 0236; Fig. 4, ref. 416] of the plurality of chambers [Para 0133]) having a second mixing outlet (See Annotated Fig. 4), the second mixing stage (referred to as chamber [Para 0236; Fig. 4, ref. 416] of the plurality of chambers [Para 0133])to mix a second plurality of fluid components (See Para 0120… (e.g., by the addition of fluid, such as a buffer, water, etc.)) to form a second fluid mixture (See Para 0120… (e.g., by the addition of fluid, such as a buffer, water, etc.), thereby teaching “a second fluid mixture”), the fluid chamber inlet (referred to as fluid channel opening [Para 0237; Fig. 4, ref. 425]) to receive the second fluid mixture from the second mixing outlet (See Annotated Fig. 4).
In addition, Claim 13 recites a process chip and then recites how the process chip function. Claim 13 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 14, the apparatus of claim 13 is obvious over Deutsch in view of Ansari.
Deutsch teaches that the process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]) further comprising at least one valve (See Para 0239…valve) , the at least one valve (See Para 0239…valve) to regulate flow of fluid from the first and second mixing outlets (See Annotated Fig. 4) to the fluid chamber inlet (referred to as fluid channel opening [Para 0237; Fig. 4, ref. 425]) such that the fluid chamber inlet (referred to as fluid channel opening [Para 0237; Fig. 4, ref. 425]) selectively receives only one of the first fluid mixture at a time (See Para 0242…the chambers within the microfluidic path device may be configured as mixing chambers, for mixing fluid within the microfluidic path device.) . The claimed limitation “or the second fluid mixture at a time” is viewed as optional and thus not required by the claim.
In addition, Claim 14 recites a process chip and then recites how the process chip function. Claim 14 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 15, the apparatus of claim 13 is obvious over Deutsch in view of Ansari.
Deutsch teaches that the process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]) further comprising a manifold (See Para 0252…manifolds) , the manifold (See Para 0252…manifolds) to direct fluid (See Para 0252…manifolds for pneumatic control…reagents) from the first and second mixing outlets (See Annotated Fig. 4) to the fluid chamber inlet (referred to as fluid channel opening [Para 0237; Fig. 4, ref. 425]).
In addition, Claim 15 recites a process chip and then recites how the process chip function. Claim 15 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 17, the apparatus of claim 1 is obvious over Deutsch in view of Ansari.
Deutsch teaches that the dynamic light scattering assembly (See Para 0290…The resulting nanoparticles may be analyzed on the microfluidic path device (e.g., by the microfluidic path device control system) for size distribution using, e.g., Dynamic Light Scattering (DLS)).
Deutsch does not teach that the dynamic light scattering assembly further including a collimator in the first port, the collimator being interposed between an end of the first optical fiber and the first exterior surface.
In the analogous art of dynamic light scattering (DLS) being disclosed for the use in accurately and reliably determining the size and/or size distribution of microscopic particles in laminar or turbulent flow, Ansari teaches that the dynamic light scattering assembly (See Para 0013; Figs. 1-3, ref. 14…DLS system) includes:
a collimator (See Para 0023… the resulting illuminated area in the flowing particle can be focused, or collimated, or diverged; Under BRI, a collimator is implicitly taught); first port (See Annotated Fig. 3), the collimator (See Para 0023… the resulting illuminated area in the flowing particle can be focused, or collimated, or diverged; Under BRI, a collimator is taught); between an end of the first optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]; Under BRI, the Fiber optic DLS probe has an end ) and the first exterior surface (See Annotated Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process chip of Deutsch to include that the dynamic light scattering assembly further including a collimator in the first port, the collimator being interposed between an end of the first optical fiber and the first exterior surface, as taught by Ansari, for the benefit of using the technique of DLS to accurately and reliably characterize the particles in flow. The present invention contemplates the use of DLS for accurate characterization of particle size and related information while the particles under study are in flow (Ansari, Para 0006), allowing for the provision of the technique of DLS can be used to accurately and reliably measure the size of the particles in flow. The present invention enables true real-time, on line, non-invasive monitoring, and characterization, especially in the field of materials processing, emulsions, colloidal engineering, product quality monitoring, quality monitoring of water and water treatment and other industrial processes. The present invention will also enable the real-time accurate characterization of biological fluid in flow (e.g., blood, biological cells, etc.) (Ansari, Abstract).
The combination of Deutsch and Ansari does not explicitly teach the location of the collimator in the dynamic light scattering assembly.
Deutsch does not teach that the dynamic light scattering assembly further including a collimator in the first port, the collimator being interposed between an end of the first optical fiber and the first exterior surface.
However, one having ordinary skill in the art at the time the invention was made would recognize these limitations as nothing more than a rearrangement of parts to effect the determination of the optimal structural configuration and design of the dynamic light scattering assembly and could seek the benefits associated with the disposition of the collimator, given that a rearrangement of parts is a supporting rationale of obviousness especially because the combination of Deutsch and Ansari discloses all the claimed structures of as cited above only in a different configuration (under broadest reasonable interpretation). Please see MPEP 2144.04(VI) (C) for further details.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the rearrangement of the claimed structural parts of the dynamic light scattering assembly for the benefit of using the technique of DLS to accurately and reliably characterize the particles in flow. The present invention contemplates the use of DLS for accurate characterization of particle size and related information while the particles under study are in flow (Ansari, Para 0006), allowing for the provision of the technique of DLS can be used to accurately and reliably measure the size of the particles in flow. The present invention enables true real-time, on line, non-invasive monitoring, and characterization, especially in the field of materials processing, emulsions, colloidal engineering, product quality monitoring, quality monitoring of water and water treatment and other industrial processes. The present invention will also enable the real-time accurate characterization of biological fluid in flow (e.g., blood, biological cells, etc.) (Ansari, Abstract).
In addition, Claim 17 recites the dynamic light scattering assembly and then recites how the dynamic light scattering assembly function. Claim 17 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 18, the apparatus of claim 17 is obvious over Deutsch in view of Ansari.
Deutsch teaches that the first port (referred to as fluid port [Fig. 4, ref. 423]) further including a focus volume (See Para 0290…Within this chamber, a fiber-optic light source may be used for the light scattering measurement to determine particle size and dispersity; Examiner submits that in In Dynamic Light Scattering (DLS), the term "focus volume" (or scattering volume) the precise area of the sample where light scattering is recorded) located near the first exterior surface (referred to as first surface [Para 0235; Fig. 4, ref. 411]).
Deutsch does not teach that the dynamic light scattering assembly further including a collimator.
In the analogous art of dynamic light scattering (DLS) being disclosed for the use in accurately and reliably determining the size and/or size distribution of microscopic particles in laminar or turbulent flow, Ansari teaches that the dynamic light scattering assembly (See Para 0013; Figs. 1-3, ref. 14…DLS system) includes:
a collimator (See Para 0023… the resulting illuminated area in the flowing particle can be focused, or collimated, or diverged; Under BRI, a collimator is implicitly taught) and the first port (See Annotated Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process chip of Deutsch to include that the dynamic light scattering assembly further including a collimator, as taught by Ansari, for the benefit of using the technique of DLS to accurately and reliably characterize the particles in flow. The present invention contemplates the use of DLS for accurate characterization of particle size and related information while the particles under study are in flow (Ansari, Para 0006), allowing for the provision of the technique of DLS can be used to accurately and reliably measure the size of the particles in flow. The present invention enables true real-time, on line, non-invasive monitoring, and characterization, especially in the field of materials processing, emulsions, colloidal engineering, product quality monitoring, quality monitoring of water and water treatment and other industrial processes. The present invention will also enable the real-time accurate characterization of biological fluid in flow (e.g., blood, biological cells, etc.) (Ansari, Abstract).
The combination of Deutsch and Ansari does not explicitly teach the location of the collimator in the dynamic light scattering assembly.
Deutsch does not teach that the dynamic light scattering assembly further including a collimator in the first port, the collimator being interposed between an end of the first optical fiber and the first exterior surface.
However, one having ordinary skill in the art at the time the invention was made would recognize these limitations as nothing more than a rearrangement of parts to effect the determination of the optimal structural configuration and design of the dynamic light scattering assembly and could seek the benefits associated with the disposition of the collimator, given that a rearrangement of parts is a supporting rationale of obviousness especially because the combination of Deutsch and Ansari discloses all the claimed structures of as cited above only in a different configuration (under broadest reasonable interpretation). Please see MPEP 2144.04(VI) (C) for further details.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the rearrangement of the claimed structural parts of the dynamic light scattering assembly for the benefit of using the technique of DLS to accurately and reliably characterize the particles in flow. The present invention contemplates the use of DLS for accurate characterization of particle size and related information while the particles under study are in flow (Ansari, Para 0006), allowing for the provision of the technique of DLS can be used to accurately and reliably measure the size of the particles in flow. The present invention enables true real-time, on line, non-invasive monitoring, and characterization, especially in the field of materials processing, emulsions, colloidal engineering, product quality monitoring, quality monitoring of water and water treatment and other industrial processes. The present invention will also enable the real-time accurate characterization of biological fluid in flow (e.g., blood, biological cells, etc.) (Ansari, Abstract).
In addition, Claim 18 recites the first port and then recites how the first port function. Claim 18 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 19, the apparatus of claim 18 is obvious over Deutsch in view of Ansari.
Deutsch further teaches that the focus volume (See Para 0290…Within this chamber, a fiber-optic light source may be used for the light scattering measurement to determine particle size and dispersity; Examiner submits that in In Dynamic Light Scattering (DLS), the term "focus volume" (or scattering volume) the precise area of the sample where light scattering is recorded) defining a conical shape (Examiner submits that under BRI, collections of light rays commonly form a conical shape when projected towards a surface).
Regarding Claim 23, the apparatus of claim 1 is obvious over Deutsch in view of Ansari.
Deutsch further teaches the body (referred to as second plate [Fig. 4, ref. 405]) including a chip-facing surface (referred to as first surface 431 [Para 0235]) to face the first exterior surface (referred to as first surface [Para 0235; Fig. 4, ref. 411]), the chip-facing surface (referred to as first surface 431 [Para 0235]) defining a first opening and a second opening (See Para 0234… there are multiple different input lines), the first port (referred to as fluid port [Fig. 4, ref. 423]); through the first opening (See Para 0234… there are multiple different input lines) to reach the optically transmissive material (See Para 0217…The microfluidic path devices described herein may generally be at least partially transparent, and in particular, may be transparent on the top of the microfluidic path device,) ; via the second opening (See Para 0234… there are multiple different input lines).
Deutsch does not teach “to direct the light emitted by the first optical fiber” and “the second optical fiber to receive scattered light”.
In the analogous art of dynamic light scattering (DLS) being disclosed for the use in accurately and reliably determining the size and/or size distribution of microscopic particles in laminar or turbulent flow, Ansari teaches “to direct the light emitted by the first optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]… launched laser light is transmitted through the transmitting fiber to the other end of the transmitting fiber. )” and “the second optical fiber (See Annotated Fig. 3…Fiber optic DLS probe[Para 0023]) to receive scattered light (See Para 0022…the detector has a focusing lens assembly (detector FLA) attached in the front in order to collect the scattered light from the focused illumination of the flowing particles. )”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process chip of Deutsch to include “to direct the light emitted by the first optical fiber” and “the second optical fiber to receive scattered light”, as taught by Ansari for the benefit of using the technique of DLS to accurately and reliably characterize the particles in flow. The present invention contemplates the use of DLS for accurate characterization of particle size and related information while the particles under study are in flow (Ansari, Para 0006), allowing for the provision of the technique of DLS can be used to accurately and reliably measure the size of the particles in flow. The present invention enables true real-time, on line, non-invasive monitoring, and characterization, especially in the field of materials processing, emulsions, colloidal engineering, product quality monitoring, quality monitoring of water and water treatment and other industrial processes. The present invention will also enable the real-time accurate characterization of biological fluid in flow (e.g., blood, biological cells, etc.) (Ansari, Abstract).
Regarding Claim 25, the apparatus of claim 1 is obvious over Deutsch in view of Ansari.
Deutsch teaches a processor (referred to as a computer (e.g. processor) executing software configure to perform all or some of these methods (e.g., a non-transitory, computer readable media encoding these instructions). [Para 0021]), the processor (referred to as a computer (e.g. processor) executing software configure to perform all or some of these methods (e.g., a non-transitory, computer readable media encoding these instructions). [Para 0021]) to determine one or both of sizes of particles (‘nanoparticles’) in fluid (See nanoparticles in solution )in the fluid chamber (referred to as fluid channel [Para 0236; Fig. 4, ref. 421]) using at least data from the dynamic light scattering assembly or size distribution of particles (See Para 0290…The resulting nanoparticles may be analyzed on the microfluidic path device (e.g., by the microfluidic path device control system) for size distribution using, e.g., Dynamic Light Scattering (DLS)) in fluid in the fluid chamber (referred to as fluid channel [Para 0236; Fig. 4, ref. 421]) using at least data from the dynamic light scattering assembly (See Para 0290…The resulting nanoparticles may be analyzed on the microfluidic path device (e.g., by the microfluidic path device control system) for size distribution using, e.g., Dynamic Light Scattering (DLS)).
Regarding Claim 26, the apparatus of claim 25 is obvious over Deutsch in view of Ansari.
Deutsch teaches the processor (referred to as a computer (e.g. processor) executing software configure to perform all or some of these methods (e.g., a non-transitory, computer readable media encoding these instructions). [Para 0021]) to use autocorrelation (See Para 0290… The resulting nanoparticles may be analyzed on the microfluidic path device (e.g., by the microfluidic path device control system) for size distribution using, e.g., Dynamic Light Scattering (DLS) and % mRNA encapsulation using fluorescence, thereby teaching “autocorrelation” ) to determine one or both of sizes of particles (‘nanoparticles’) in fluid (See nanoparticles in solution )in the fluid chamber (referred to as fluid channel [Para 0236; Fig. 4, ref. 421]) using at least data from the dynamic light scattering assembly or size distribution of particles (See Para 0290…The resulting nanoparticles may be analyzed on the microfluidic path device (e.g., by the microfluidic path device control system) for size distribution using, e.g., Dynamic Light Scattering (DLS)) in fluid in the fluid chamber (referred to as fluid channel [Para 0236; Fig. 4, ref. 421]) using at least data from the dynamic light scattering assembly (See Para 0290…The resulting nanoparticles may be analyzed on the microfluidic path device (e.g., by the microfluidic path device control system) for size distribution using, e.g., Dynamic Light Scattering (DLS)).
Regarding Claim 28, the apparatus of claim 1 is obvious over Deutsch in view of Ansari.
Deutsch teaches that the encapsulated nucleotides (See Para 0010…encapsulating the therapeutic mRNA with a delivery vehicle to form a therapeutic mRNA composition; See Para 0301… The nucleic acid mix may be encapsulated into 200 nm ANPs) including encapsulated mRNA (See Para 0010…encapsulating the therapeutic mRNA with a delivery vehicle to form a therapeutic mRNA composition ;See Para 0301… The nucleic acid mix may be encapsulated into 200 nm ANPs).
Regarding Claim 72, the apparatus of claim 1 is obvious over Deutsch in view of Ansari.
Deutsch further teaches the body (referred to as second plate [Fig. 4, ref. 405]) to orient the first optical fiber along an axis that perpendicular to the first exterior surface (referred to as first surface [Para 0235; Fig. 4, ref. 411]) of the process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]).
Deutsch does not teach “to orient the first optical fiber along an axis that perpendicular to the first exterior surface”.
In the analogous art of dynamic light scattering (DLS) being disclosed for the use in accurately and reliably determining the size and/or size distribution of microscopic particles in laminar or turbulent flow, Ansari teaches “to orient the first optical fiber (See Annotated Fig. 3) along an axis that perpendicular (See Annotated Fig. 3) to the first exterior surface (See Annotated Fig. 3)”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process chip of Deutsch to include “to orient the first optical fiber along an axis that perpendicular to the first exterior surface”, as taught by Ansari for the benefit of using the technique of DLS to accurately and reliably characterize the particles in flow. The present invention contemplates the use of DLS for accurate characterization of particle size and related information while the particles under study are in flow (Ansari, Para 0006), allowing for the provision of the technique of DLS can be used to accurately and reliably measure the size of the particles in flow. The present invention enables true real-time, on line, non-invasive monitoring, and characterization, especially in the field of materials processing, emulsions, colloidal engineering, product quality monitoring, quality monitoring of water and water treatment and other industrial processes. The present invention will also enable the real-time accurate characterization of biological fluid in flow (e.g., blood, biological cells, etc.) (Ansari, Abstract).
Regarding Claim 73, the apparatus of claim 72 is obvious over Deutsch in view of Ansari.
Deutsch further teaches the body (referred to as second plate [Fig. 4, ref. 405]) to orient the second optical fiber along an axis that perpendicular to the first exterior surface (referred to as first surface [Para 0235; Fig. 4, ref. 411]) of the process chip (referred to as the microfluidic path device [Para 0235; Fig. 4, ref. 400]).
Deutsch does not teach “to orient the second optical fiber along an axis that perpendicular to the first exterior surface”.
In the analogous art of dynamic light scattering (DLS) being disclosed for the use in accurately and reliably determining the size and/or size distribution of microscopic particles in laminar or turbulent flow, Ansari teaches “to orient the second optical fiber (See Annotated Fig. 3) along an axis that perpendicular (See Annotated Fig. 3) to the first exterior surface (See Annotated Fig. 3)”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process chip of Deutsch to include “to orient the second optical fiber along an axis that perpendicular to the first exterior surface”, as taught by Ansari for the benefit of using the technique of DLS to accurately and reliably characterize the particles in flow. The present invention contemplates the use of DLS for accurate characterization of particle size and related information while the particles under study are in flow (Ansari, Para 0006), allowing for the provision of the technique of DLS can be used to accurately and reliably measure the size of the particles in flow. The present invention enables true real-time, on line, non-invasive monitoring, and characterization, especially in the field of materials processing, emulsions, colloidal engineering, product quality monitoring, quality monitoring of water and water treatment and other industrial processes. The present invention will also enable the real-time accurate characterization of biological fluid in flow (e.g., blood, biological cells, etc.) (Ansari, Abstract).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Deutsch et al. (US20210040472A1, submitted in IDS on 10/13/2023) in view of Ansari et al. (US20020180972A1, submitted in IDS on 10/13/2023) as applied to claim 5 above, and further in view of Davies et al. (US20100297748A1).
Regarding Claim 6, the apparatus of claim 5 is obvious over Deutsch in view of Ansari.
Deutsch further teaches a first mixing outlet (See Annotated Fig. 4).
The combination of Deutsch and Ansari does not teach that the first mixing stage including a first mixing inlet, a second mixing inlet, and a first mixing outlet, the first mixing inlet to receive a first fluid component, the second mixing inlet to receive a second fluid component, the first mixing outlet to output the first fluid mixture, the first fluid mixture comprising at least the first fluid component and the second fluid component.
In the analogous art of an integrated fluidic circuit, Davies teaches that the first mixing stage (referred to as main chamber [Para 0024]) including a first mixing inlet (referred to as inlet 103 [Para 0024]), a second mixing inlet (referred to as inlet 105 [Para 0024]), and a first mixing outlet (referred to as outlet 104 [Para 0024]), the first mixing inlet (referred to as inlet 103 [Para 0024]) to receive a first fluid component (See Para 0024…a first sample droplet flows through a first channel to inlet 103), the second mixing inlet (referred to as inlet 105 [Para 0024]) to receive a second fluid component (See Para 0024…a second sample droplet flows through a second channel to inlet 105.), the first mixing outlet (referred to as outlet 104 [Para 0024]) to output the first fluid mixture (See Para 0024…the mixed sample droplet enters the outlet 104,), the first fluid mixture (See Para 0024…the mixed sample droplet ) comprising at least the first fluid component (See Para 0024…a first sample droplet) and the second fluid component (See Para 0024…a second sample droplet).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of the combination of Deutsch and Ansari to include that the first mixing stage including a first mixing inlet, a second mixing inlet, and a first mixing outlet, the first mixing inlet to receive a first fluid component, the second mixing inlet to receive a second fluid component, the first mixing outlet to output the first fluid mixture, the first fluid mixture comprising at least the first fluid component and the second fluid component, as taught by Davies for the benefit of providing devices of the invention that reduce system complexity and system size (Davies, Para 0008), allowing for the provision of systems and devices that can integrate numerous liquid bridges within a single system (Davies, Para 0007).
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Annotated Fig. 4, Deutsch
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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