DETAILED ACTION
Applicant’s response filed 05/29/2026 has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied.
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 .
Status of the Claims
Claims 1-22 are pending and under consideration in this action. Claims 21-22 are newly added in the amendment filed 05/29/2026.
Priority
The instant application does not claim domestic or foreign benefit, as reflected in the filing receipt mailed 4/22/2022. The filing date of the instant application is the effective filing date of claims 1-22. As such, the effective filing date of claims 1-22 is 4/19/2022.
Claim Rejections - 35 USC § 112(a)
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is newly recited and necessitated by claim amendment.
Claims 1, 17, and 19 recite the limitation “operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer”. The instant Specification (see Para. [0021]) discloses that the computational methods of one or more embodiments may be beneficial to optimize fluid channel design and/or to control the motion of a biopolymer in a fluid channel for the purpose of characterizing its properties. The Specification (see Para. [0032]) further discloses that the fluid flow velocity and/or the fluid flow pressure are applied to fluid channel design parameters and/or operational conditions. Non-limiting examples of fluid channel design parameters include fluid channel size, presence of one or more pillars within the fluid channel, and/or fluid inlet profile. Non-limiting examples of operational conditions include salt concentration, electric field strength, fluid channel wall charge and/or fluid channel wall surface treatment. The Specification (see Para. [0033]) further discloses that a biomolecule can be mapped under the channel design parameters and/or operational conditions. In one or more embodiments, the design and range of operation of the fluid channel is optimized to achieve efficient and accurate biomolecule mapping and/or sequencing. However, the Specification is silent on steps, parameters, or examples for physically operating the fluid channel using the characterized property (e.g., using the properties in claim 10), as recited in claims 1, 17, and 19.
Additionally, the non-transitory computer-readable medium and computer system recited in claims 17 and 19 would need to be operably linked to the fluid channel in order to operate the fluid channel as claimed. The Specification (see Para. [0034]-[0040]) discloses the computer components of both systems, but is silent on both non-transitory computer-readable medium and computer system being operably connected to the fluid channel system for its control/operation Accordingly, the disclosure is not commensurate with the written description scope of the claim. This is a NEW MATTER rejection.
Claim Rejections - 35 USC § 112(b)
Withdrawn Rejections
The rejection of claim 15 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments to the claims filed 05/29/2026 (Applicant’s Remarks, Pg. 7).
Newly Recited Rejections
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This rejection is newly recited and necessitated by claim amendment.
Claim 1 recites the phrase “receiving a dimensional representation of a molecule concentration over time within a fluid flow of a fluid medium including dye molecules flowing through a fluid channel including the biopolymer” in lines 3-5 of the claim. There is insufficient antecedent basis for the biopolymer in the amended claim, as there is no prior mention of the biopolymer earlier in the claim. This rejection can be overcome by amendment of claim 1 to recite “receiving a dimensional representation of a molecule concentration over time within a fluid flow of a fluid medium including dye molecules flowing through a fluid channel including a biopolymer”. Claims 2-16 and 21-22 are also rejected due to their dependency from claim 1.
Claim 12 recites the phrase “wherein the one or more operational conditions of the fluid flow and/or the fluid channel include a fluid channel wall surface treatment” in lines 1-3 of the claim. There is insufficient antecedent basis for the one or more operational conditions in the claim, as there is no prior mention of this phrase in claim 1, to which this claim depends. For the purpose of compact prosecution, this claim will be interpreted to be dependent on claim 5, which contains the phrase “one or more operational conditions”; however, correction is respectfully requested.
Claim 14 recites the phrase “wherein the one or more operational conditions of the fluid flow and/or the fluid channel include a salt concentration” in lines 1-3 of the claim. There is insufficient antecedent basis for the one or more operational conditions in the claim, as there is no prior mention of this phrase in claim 1, to which this claim depends. For the purpose of compact prosecution, this claim will be interpreted to be dependent on claim 5, which contains the phrase “one or more operational conditions”; however, correction is respectfully requested.
Claim 17 recites the phrase “…the buffer solution flowing through the fluid channel including the biopolymer…” in lines 7-8 of the claim. There is insufficient antecedent basis for the fluid channel in the claim, as there is no prior mention of this phrase earlier in the claim. This rejection can be overcome by amendment of claim 17 to recite “…the buffer solution flowing through the fluid channel including a biopolymer…”. Claim 18 is also rejected due to its dependency from claim 17.
Claim 17 also recites the phrase “…the buffer solution flowing through the/a fluid channel including a biopolymer, the molecular concentration is an aggregate concentration of the first and second dye molecule types”. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. First, there is insufficient antecedent basis for the molecular concentration in the claim, as there is no prior mention of this phrase earlier in the claim (instead reciting “a molecule concentration”). Second, it is unclear how “the molecular concentration is an aggregate concentration” is included in the fluid channel, as it appears to be a characterization of the dye molecules recited earlier in the limitation. Examiner suggests amendment of claim 17 to recite “…the buffer solution flowing through a fluid channel including a biopolymer, wherein the molecule concentration is an aggregate concentration of the first and second dye molecule types” to resolve both the antecedent basis and ambiguity. Claim 18 is also rejected due to its dependency from claim 17.
Claims 17 and 19 also recites the phrase “predicting a fluid flow velocity and/or a fluid flow pressure of the fluid medium in response to the dimensional representation of the molecule concentration over time within the fluid medium using a machine learning model” in lines 10-12 and 12-14 of the claims, respectively. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. First, there is insufficient antecedent basis for the fluid medium in the claim, as there is no prior mention of this phrase earlier in the claim. Second, it is now unclear if the recited “fluid medium” is now the “buffer solution” recited in the previous step. This rejection can be overcome by amendment of claims 17 and 19 to correct the antecedent basis of the fluid medium and clarify whether the fluid medium is now intended to be the recited buffer solution for analysis using the machine learning model. Claims 18 and 20 are also rejected due to their dependency from claims 17 and 19.
Claim Rejections - 35 USC § 101
Maintained Rejections
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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite mental processes, i.e., concepts performed in the human mind (including observations, evaluations, judgements or opinions) (see MPEP § 2106.04(a)).
Any newly recited portion is necessitated by claim amendment.
Step 1:
In the instant application, claims 1-16 and 21-22 are directed towards a method; claims 17-18 are directed towards a manufacture, and claims 19-20 are directed towards a system, which falls into one of the categories of statutory subject matter (Step 1: YES).
Step 2A, Prong One:
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong One). The following instant claims recite limitations that equate to one or more categories of judicial exceptions:
Claims 1, 17, and 19 recite a mental process (i.e., an evaluation in comparing the fluid response to known properties; see instant specification Para. [0025]) in "characterizing the biopolymer property of the biopolymer in response to the fluid flow velocity and/or the fluid flow pressure".
Claims 2, 18, and 20 recites a mental process (i.e., an evaluation of the dimensional representation) in “wherein the dimensional representation is an optical pattern”.
Claim 3 recites a mental process (i.e., an observation of the fluid channel type) in “wherein the fluid channel is a biopolymer mapping device”.
Claim 4 recites a mental process (i.e., an observation of the fluid channel type) in “wherein the fluid channel is a micro-fluid channel or a nano-fluid channel”.
Claim 5 recites a mental process (i.e., an evaluation of the design parameters or operational conditions to determine responsiveness) in “wherein the dimensional representation is responsive to one or more design parameters of the fluid channel and/or one or more operational conditions of the fluid flow and/or the fluid channel”.
Claim 6 recites a mental process (i.e., an observation and/or evaluation of the design parameters for the fluid channel) in “wherein the one or more design parameters of the fluid channel include a fluid channel size, a presence of one or more pillars within the fluid channel and/or a fluid inlet profile”.
Claim 7 recites a mental process (i.e., an observation and/or evaluation of the operation conditions of the flow or channel) in “wherein the one or more operational conditions of the fluid flow and/or the fluid channel include a salt concentration, and/or a fluid channel wall surface treatment”.
Claim 8 recites a mental process (i.e., an evaluation of the size of the biopolymer segments) in “wherein the biopolymer includes biopolymer segments having lengths of less than 1 micron”.
Claim 9 recites a mental process (i.e., an evaluation of the type of machine learning model) in “wherein the machine learning model is a physics-informed neural network model”.
Claim 10 recites a mental process (i.e., an evaluation of the type of biopolymer property) in “wherein the biopolymer property includes a translocation speed, an effective drag, a conformation, a mechanical stiffness, a relaxation time, and/or an effective charge”.
Claim 11 recites a mental process (i.e., an evaluation of the type of biopolymer) in “wherein the biopolymer is DNA, RNA, microRNA, a protein, or a lipid”.
Claim 12 recites a mental process (i.e., an observation and/or evaluation of the operation conditions of the flow or channel) in “wherein the one or more operational conditions of the fluid flow and/or the fluid channel include a fluid channel wall surface treatment”.
Claim 13 recites a mental process (i.e., an evaluation of the type of biopolymer property) in “wherein the biopolymer property includes a biopolymer translocation velocity”.
Claim 14 recites a mental process (i.e., an observation and/or evaluation of the operation conditions of the flow or channel) in “wherein the one or more operational conditions of the fluid flow and/or the fluid channel include a salt concentration”.
Claim 15 recites a mental process (i.e., an evaluation of the relationship between the translocation velocity and the design parameters) in “characterizing a relationship between the biopolymer translocation velocity and one or more design parameters of the fluid channel and/or one or more operational conditions of the fluid flow and/or the fluid channel”.
Claim 21 recites a mental process (i.e., an observation and/or evaluation of the operation conditions of the flow or channel) in “wherein the one or more operational conditions of the fluid flow and/or the fluid channel include an electric field strength”.
Claim 22 recites a mental process (i.e., an evaluation of the biopolymer property) in “wherein the biopolymer property includes an elastic response”.
These recitations are similar to the concepts of collecting information, and displaying certain results of the collection and analysis is Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)), and organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships.
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification, and are determined to be directed to mental processes that in the simplest embodiments are not too complex to practically perform in the human mind. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Specifically, claims 1, 17, and 19 involves nothing more than characterizing the biopolymer property. Since there are no specifics in the methodology, the characterization of the biopolymer property based on the predicted fluid flow velocity or pressure, is something that under BRI, one could perform mentally. Therefore, the claimed steps are not further defined beyond something that reads merely looking at data and making a determination. As such, said steps are directed to judicial exceptions. The instant claims must therefore be examined further to determine whether they integrate the abstract idea into a practical application (Step 2A, Prong One: YES).
Step 2A, Prong Two:
In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP § 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP § 2106.04(d)(I)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP § 2106.04(d)(III)). The following independent claims recite limitations that equate to additional elements:
Claim 1 recites “receiving a dimensional representation of a molecule concentration over time within a fluid flow of a fluid medium including dye molecules flowing through a fluid channel including the biopolymer”; “predicting a fluid flow velocity and/or a fluid flow pressure of the fluid medium in response to the dimensional representation of the molecule concentration over time within the fluid medium including the dye molecules using a machine learning model without direct imaging of biopolymer dynamics”; and “operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer”.
Claim 17 recites “a non-transitory computer-readable medium tangibly embodying computer readable instructions for a software program, the software program being executable by a processor of a computing device”; “receiving a dimensional representation of a molecule concentration over time within a fluid flow of a buffer solution of dye molecules including a first dye molecule type having a first diffusion property and a second dye molecule type having a second diffusion property different than the first diffusion property, the buffer solution flowing through the fluid channel including a biopolymer, the molecular concentration is an aggregate concentration of the first and second dye molecule types”; “predicting a fluid flow velocity and/or a fluid flow pressure of the fluid medium in response to the dimensional representation of the molecule concentration over time within the fluid medium using a machine learning model”; and “operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer”.
Claim 19 recites “a computer having a processor for executing computer-readable instructions and a memory for maintaining the computer-executable instructions, the computer-executable instructions when executed by the processor”; “receiving a dimensional representation of a molecule concentration over time within a fluid flow of a buffer solution of dye molecules including a first dye molecule type having a first diffusion property and a second dye molecule type having a second diffusion property different than the first diffusion property, the buffer solution flowing through a fluid channel including the biopolymer, the molecular concentration is an aggregate concentration of the first and second dye molecule types”; “predicting a fluid flow velocity and/or a fluid flow pressure of the fluid medium in response to the dimensional representation of the molecule concentration over time within the fluid medium using a machine learning model”; and “operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer”.
Regarding the above cited limitations in claims 1, 17, and 19 of (i) receiving a dimensional representation of a molecule concentration over time within a fluid flow of a fluid medium including dye molecules flowing through a fluid channel including the biopolymer (claim 1); (ii) receiving a dimensional representation of a molecule concentration over time within a fluid flow of a buffer solution of dye molecules including a first dye molecule type having a first diffusion property and a second dye molecule type having a second diffusion property different than the first diffusion property, the buffer solution flowing through the fluid channel including a biopolymer, the molecular concentration is an aggregate concentration of the first and second dye molecule types (claims 17 and 19); and (iii) predicting a fluid flow velocity and/or a fluid flow pressure of the fluid medium in response to the dimensional representation of the molecule concentration over time within the fluid medium [including the dye molecules] using a machine learning model [without direct imaging of biopolymer dynamics] (claims 1, 17, and 19). These limitations equate to insignificant, extra-solution activity of mere data gathering because these limitations gather data before or after the recited judicial exception of characterizing the biopolymer property of the biopolymer in response to the fluid flow velocity and/or the fluid flow pressure (see MPEP § 2106.04(d)).
Regarding the above cited limitation in claims 1, 17, and 19 of (iv) operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer. This limitation equates to an extra-solution “apply it” step, because the limitation is used to physically operate the fluid channel without providing any details, steps, or parameters of how to operate the channel depending on any biopolymer property (see MPEP § 2106.05(f)).
Regarding the above cited limitations in claims 17 and 19 of (v) a non-transitory computer-readable medium tangibly embodying computer readable instructions for a software program, the software program being executable by a processor of a computing device (claim 17); and (vi) a computer having a processor for executing computer-readable instructions and a memory for maintaining the computer-executable instructions, the computer-executable instructions when executed by the processor perform functions (claim 19). These limitations require only a generic computer component, which does not improve computer technology. Therefore, these limitations equate to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983. As such, claims 1-22 are directed to an abstract idea (Step 2A, Prong Two: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant independent claims recite the same additional elements described in Step 2A, Prong Two above.
Regarding the above cited limitations in claims 17 and 19 of (v) a non-transitory computer-readable medium tangibly embodying computer readable instructions for a software program, the software program being executable by a processor of a computing device (claim 17); and (vi) a computer having a processor for executing computer-readable instructions and a memory for maintaining the computer-executable instructions, the computer-executable instructions when executed by the processor perform functions (claim 19). These limitations equate to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept (see MPEP § 2106.05(d) and MPEP § 2106.05(f)).
Regarding the above cited limitations in claims 1, 17, and 19 of (i) receiving a dimensional representation of a molecule concentration over time within a fluid flow of a fluid medium including dye molecules flowing through a fluid channel including the biopolymer (claim 1); (ii) receiving a dimensional representation of a molecule concentration over time within a fluid flow of a buffer solution of dye molecules including a first dye molecule type having a first diffusion property and a second dye molecule type having a second diffusion property different than the first diffusion property, the buffer solution flowing through the fluid channel including a biopolymer, the molecular concentration is an aggregate concentration of the first and second dye molecule types (claims 17 and 19). These limitations do not include any specific steps for acquiring the dimensional representation of the dye molecules. Under the BRI, these limitations are merely receiving data for the subsequent step of predicting the fluid flow velocity or pressure with a machine learning model. Therefore, these limitations equate to receiving/transmitting data over a network, which the courts have established as a WURC limitation of a generic computer in buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014).
Regarding the above cited limitations in claims 1, 17, and 19 of (iii) predicting a fluid flow velocity and/or a fluid flow pressure of the fluid medium in response to the dimensional representation of the molecule concentration over time within the fluid medium [including the dye molecules] using a machine learning model [without direct imaging of biopolymer dynamics] (claims 1, 17, and 19) and (iv) operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer (claims 1, 17, 19). These limitations when viewed individually and in combination, are WURC limitations as taught by Zeng et al. (Deep-learning Assisted Extraction of Fluid Velocity from Scalar Signal Transport in a Shallow Microfluidic Channel. arXiv:2112.00385 (2021); previously cited) and Zhou et al. (Enhanced nanochannel translocation and localization of genomic DNA molecules using three-dimensional nanofunnels. Nat Commun 8, 807 (2017); previously cited). Zeng et al. discloses a deep neural network assisted scalar image velocimetry (DNN-SIV) method for prediction of fluid velocity in microfluidic channels (Abstract). The method is time dependent and incorporates fluorescent dyes and proteins in the fluid, without any imaging (limitation (iii)) (Pg. 4, Para. 2; Pg. 3, Para. 3-4; Pg. 4, Fig. 1; and Pg. 5, Fig. 2). Additionally, Zhou et al. discloses a method of electrokinetically introducing DNA molecules into a nanochannel, facilitated by incorporating a three-dimensional nanofunnel at the nanochannel entrance. In some cases, DNA molecules are stably trapped and axially positioned within a nanofunnel at sub-threshold electric field strengths (limitation (iv)) (Abstract).
These additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the instant claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 1-22 are not patent eligible.
Response to Arguments under 35 U.S.C. 101
Applicant’s arguments filed 05/29/2026 have been fully considered but they are not persuasive.
1. Applicant argues that independent claims 1, 17, and 19 recite the limitation “operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer” (claim 17 with a non-transitory computer-readable medium and claim 19 with a computer system). These recitations require operation of a physical microfluidic and/or nanofluidic device to physically manipulate transport of a biopolymer within the channel. Such operation of a fluid channel and control of movement of a physical biopolymer cannot practically be performed in the human mind and does not constitute a mere mental process. (Applicant’s Remarks, Pg. 7-8).
It is respectfully submitted that this is not persuasive for the following reasons:
The limitation in claims 1, 17, and 19, identified by Applicant, of “operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer” has been identified as an additional element in Step 2A, Prong Two above. Limitations that recite additional elements do not need to be practically performed in the human mind, as they do not recite any judicial exceptions (see MPEP § 2106.04). This argument is thus not persuasive.
2. Applicant argues that the Office Action characterizes the control recitation as insignificant extra-solution activity and/or data gathering. The claimed control operation is not ancillary post-processing or mere presentation of information. Rather, the claimed control step/function affirmatively changes operation of the fluid channel and changes movement of the biopolymer within the fluid medium. The claimed methods, computer-readable medium, and systems therefore recite a concrete technological application involving operation of a physical laboratory system and manipulation of physical matter (Applicant’s Remarks, Pg. 8).
It is respectfully submitted that this is not persuasive for the following reasons:
The newly added limitation in amended claims 1, 17, and 19 to control the operation of the fluid channel, “operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer” has been identified as an extra solution “apply it” step in Step 2A, Prong Two above. The limitation is used to physically operate the fluid channel without providing any steps or parameters indicating how any biopolymer property can be used to control the fluid channel. Accordingly, the limitation recites the idea of an outcome, with no restriction on how the result is accomplished, and no description of the mechanism for accomplishing the result (see MPEP § 2106.05(f)). Subsequent analysis of this limitation under Step 2B above shows that it is well-understood, routine, and conventional as taught by Zhou et al. (see Step 2B above). This argument is thus not persuasive.
3. Applicant argues that the pending claims are therefore unlike claims directed merely to collecting information, analyzing information, and displaying results, such as those discussed in Electric Power Group, LLC v. Alstom SA, 830 F.3d 1350 (Fed. Cir. 2016). Instead, the pending claims are directed to controlling operation of a fluidic device using machine-learning-derived fluid flow characteristics to manipulate biopolymer transport within the channel. The pending claims are therefore directed to a practical technological process and not to a mental process (Applicant’s Remarks, Pg. 8).
It is respectfully submitted that this is not persuasive for the following reasons:
Amended claims 1, 17, and 19 recite the following limitation reciting a mental process (see Step 2A, Prong One above): “characterizing the biopolymer property of the biopolymer in response to the fluid flow velocity and/or the fluid flow pressure”. Since there are no steps or parameters indicating how the biopolymer property is characterized, under the BRI, this is a step can practically be performed in the human mind. The mental characterization is analogous to the analysis of information in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)) and the comparison of information in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)).
Additionally, as described in argument (1) above, the additional elements in the claim do not need to be practically performed in the human mind. Therefore, since the “characterization” limitation recites a mental process, and the additional elements in the claims do not integrate the judicial exception into a practical application, the claims are directed to an abstract idea (see Step 2A, Prong One; Step 2A, Prong Two; and arguments directly above). This argument is thus not persuasive.
4. Applicant argues that even if certain aspects of the claims could be characterized as involving a mental process, the pending claims integrate any alleged abstract idea into a practical application. The claims use the predicted fluid flow velocity and/or pressure to operate the fluid channel by controlling motion of the biopolymer within the channel. The pending claims therefore impose meaningful limits on any alleged abstract idea and improve operation of fluidic biopolymer analysis systems. Accordingly, the pending claims are eligible under Step 2A of the USPTO eligibility framework (Applicant’s Remarks, Pg. 9).
It is respectfully submitted that this is not persuasive for the following reasons:
As described in Step 2A, Prong Two, Step 2B, and argument (2) above, the limitation reciting “operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer” does not impose meaningful limits on the abstract idea to improve the operation of the fluidic system. Briefly, the limitation is an extra-solution “apply it” step under Step 2A, Prong One, and a well-understood, routine, and conventional limitation under Step 2B, as described in detail above. This argument is thus not persuasive.
5. Applicant argues that even if the pending claims recite a judicial exception, the claims nevertheless include significantly more than any alleged abstract idea and therefore recite an inventive concept under Step 2B. The Office Action's reliance on the cited references as allegedly demonstrating well-understood, routine, and conventional activity is inconsistent with Applicant's traversal of the pending § 103 rejections. The cited references do not disclose or suggest the claimed combination as arranged in the pending claims. Accordingly, the pending claims recite significantly more than any alleged judicial exception and satisfy Step 2B of the eligibility analysis (Applicant’s Remarks, Pg. 9).
It is respectfully submitted that this is not persuasive for the following reasons:
MPEP § 2106.05(I) recites:
Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting "the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101 "). As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty."). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) ("The inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . . [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces."). Specifically, lack of novelty under 35 U.S.C. 102 or obviousness under 35 U.S.C. 103 of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements. Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. The distinction between eligibility (under 35 U.S.C. 101 ) and patentability over the art (under 35 U.S.C. 102 and/or 103 ) is further discussed in MPEP § 2106.05(d).
Whether or not the claimed elements appear to be free of the prior art is distinct from subject matter eligibility under 35 U.S.C. 101. As discussed in the rejection above, the additional elements in the amended claims 1, 17, and 19 either equate to receiving/transmitting data over a network (which the courts have established as a WURC limitation of a generic computer), or as well-understood, routine, and conventional (WURC) limitations as taught by Zeng et al. and Zhou et al. For the sake of not iterating the rejection, the limitation of “receiving a dimensional representation…” equates to receiving/transmitting data over a network, the limitation of “predicting a fluid flow velocity…” is WURC limitation as taught by Zeng et al., and the limitation of “operating the fluid channel…” is a WURC limitation as taught by Zhou et al. Therefore, when viewed individually and in combination, these additional element limitations do not equate to significantly more than the judicial exception. Therefore, this argument is not persuasive and the rejection under 35 U.S.C. 101 is maintained.
Claim Rejections - 35 USC § 103
Withdrawn Rejections
The rejection of claims 7, 12, 14, and 17-20 under 35 U.S.C. 103 as being unpatentable over Zhou et al. in view of Zeng et al. is withdrawn in view of Applicant’s amendments to the claims filed 05/29/2026 (Applicant’s Remarks, Pg. 9-12). Specifically, Zhou et al. in view of Zeng et al. does not disclose the operational conditions of a salt concentration or a fluid channel wall surface treatment, as disclosed in amended claims 7, 12, and 14. Zhou et al. in view of Zeng et al. also does not disclose the fluid flow of a buffer solution containing two dyes measured using an aggregate molecular concentration, as disclosed in amended independent claims 17 and 19.
The rejection of claim 12 under 35 U.S.C. 103 as being unpatentable over Zhou et al. in view of Zeng et al. and Benninger et al. is withdrawn in view of Applicant’s amendments to the claims filed 05/29/2026 (Applicant’s Remarks, Pg. 9-12). Specifically, Zhou et al. in view of Zeng et al. and Benninger et al. does not disclose the operational conditions of a salt concentration or a fluid channel wall surface treatment, as disclosed in amended claim 12.
Maintained Rejections
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.
1. Claims 1-6, 8-11, 13, 15-16, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (Enhanced nanochannel translocation and localization of genomic DNA molecules using three-dimensional nanofunnels. Nat Commun 8, 807 (2017); published 10/9/2017; previously cited) in view of Zeng et al. (Deep-learning Assisted Extraction of Fluid Velocity from Scalar Signal Transport in a Shallow Microfluidic Channel. arXiv:2112.00385 (2021). DOI: 10.48550/arXiv.2112.00385; published 12/1/2021; provided in the IDS dated 11/1/2023; previously cited).
Any newly recited portion is necessitated by claim amendment.
Regarding claim 1, Zhou et al. teaches a method to precisely control and understand the transport of single DNA molecules through a nanoscale channel. Individual DNA molecules are imaged as they attempt to overcome the entropic barrier to nanochannel entry through nanofunnels with various shapes. Theoretical modeling of this behavior reveals the pushing and pulling forces that result in up to a 30-fold reduction in the threshold electric field needed to initiate nanochannel entry (i.e., a method of operating a fluid channel) (Abstract). Zhou et al. further teaches the measurement of DNA molecules within a three-dimensional nanofunnel in Fig. 2. The figure shows representative images recording the position and conformation of a λ-phage DNA molecule at various time points as it is electrokinetically driven from right to left through a nanofunnel and into the associated nanochannel. The top panel is a bright-field image showing the position of the nanofunnel and nanochannel and the voltage polarity applied across the nanofunnel–nanochannel device. The numbered frames (1–5) are fluorescence images of the DNA molecule stained with an intercalating dye recorded at the indicated time points. Image analysis determined the positions of the molecule’s leading (x0) and trailing (xN) ends at each time point (Pg. 3, Fig. 2). Additionally, lambda-phage DNA (Promega) or T4-phage DNA (Nippon Gene) in 2X TBE was stained with the intercalating dye, YOYO-1, at a base-pair: dye ratio of 5:1. Solutions containing 0.5 ng/μL of DNA (16 pM for λ-phage and 4.6 pM for T4-phage) also contained 4% β-mercaptoethanol to limit photo-induced damage and 2% polyvinylpyrrolidone to reduce electro-osmotic flow within the channels (i.e., receiving a dimensional representation of a molecule concentration over time within a fluid flow of a fluid medium including dye molecules flowing through a fluid channel including the biopolymer) (Pg. 6, Col. 2, Para. 3). Zhou et al. further teaches the velocity profiles around a DNA molecule stalled/trapped in bulk solution and around a stalled/trapped DNA molecule under confinement in a nanofunnel in Supplementary Fig. 6 (i.e., in response to the fluid flow velocity) (Supplementary Information, Pg. 6, Supp. Fig. 6). Zhou et al. further teaches the DNA conformation (position, length, and packing density) associated with trapped molecules (Pg. 5, Fig. 4b/c) as well as the calculated relative free energies at different nanochannel electric field strengths of a DNA molecule as a function of its leading end position within the nanofunnel–nanochannel (i.e., characterizing the biopolymer property of the biopolymer in response to the fluid flow velocity) (Pg. 3, Fig. 2c). Zhou et al. further teaches that stable DNA can be trapped in a nanofunnel using applied electric fields (Pg. 5, Col. 1, Para. 1). At the lowest field strengths, the molecule is weakly trapped and thermal fluctuations are larger and highly correlated as the molecule fluctuates as a whole along the longitudinal nanofunnel axis. At higher electric fields, the correlations between fluctuations of the ends are reduced as compression of the leading sections of the molecule suppresses the fluctuations of this end, whereas the less constrained trailing end of the molecule is freer to fluctuate (i.e., operating the fluid channel by controlling the motion of the biopolymer in the fluid channel depending on the biopolymer property of the biopolymer) (Pg. 5, Col. 2, Para. 1).
Regarding claims 2, 18, and 20, Zhou et al. teaches representative images recording the position and conformation of a λ-phage DNA molecule at various time points through a nanofunnel and into the associated nanochannel. The numbered frames in Fig. 2 are fluorescence images of the DNA molecule stained with an intercalating dye recorded at the indicated time points. Image analysis determined the positions of the molecule’s leading (x0) and trailing (xN) ends at each time point (i.e., wherein the dimensional representation is an optical pattern) (Pg. 3, Fig. 2).
Regarding claim 3, Zhou et al. teaches representative images recording the position and conformation of a λ-phage DNA molecule at various time points through a nanofunnel and into the associated nanochannel (i.e., wherein the fluid channel is a biopolymer mapping device) (Pg. 3, Fig. 2).
Regarding claim 4, Zhou et al. teaches the transport of single DNA molecules through nanochannels (i.e., wherein the fluid channel is a nanofluid channel) (Abstract).
Regarding claim 5, Zhou et al. teaches that the residence time changes at various nanochannel electric field strengths, E, in three different nanofunnels (defined by α = 0.78, α = 0.45, and α = 0) (Pg. 4, Fig. 3). Zhou et al. further teaches that the residence time is determined using the leading edge of the DNA measured from the fluorescence images (i.e., wherein the dimensional representation is responsive to one or more design parameters of the fluid channel) (Pg. 3, Fig. 2). Zhou et al. further teaches that the position of a molecule’s leading end within a nanofunnel measured at three different nanochannel electric field strengths: 77.5 V/cm, 54.3 V/cm, and 15.5 V/cm (i.e., wherein the dimensional representation is responsive to one or more operational conditions of the fluid channel) (Pg. 3, Fig. 2).
Regarding claim 6, Zhou et al. teaches that the field-dependent residence times were measured in nanofunnels with comparable dimensions but different shapes, as well as for DNA entry into a nanochannel without an incorporated nanofunnel. The nanofunnel shape was defined using the following equation:
y
x
≈
z
x
=
D
x
x
D
α
, where
y
x
and
z
x
are the funnel width and depth, respectively, at position
x
>
0
along the funnel’s longitudinal axis,
D
is the widest dimension of the nanofunnel, and
x
D
is the nanofunnel length. In this study,
D
= 1.6 ± 0.1 μm,
x
D
= 21.5 ± 0.2 μm, and the nanochannel width and depth were each 120 ± 15 nm. Residence time measurements were performed in nanofunnels defined by
α
values of 0, 0.45, and 0.78, whereas supplementary experiments were conducted in nanofunnels with
α
values of 1.46 and 1.89 (i.e., wherein the one or more design parameters of the fluid channel include a fluid inlet profile) (Pg. 4, Col. 1, Para. 2).
Regarding claim 8, Zhou et al. teaches that data were collected using stained λ-phage (48.5 kbp) and T4-phage (165.6 kbp) DNA molecules. The molecule can be segmented into a 3000-bp segment or smaller (i.e., wherein the biopolymer includes biopolymer segments having lengths of less than 1 micron) (Pg. 4, Fig. 3).
Regarding claim 10, Zhou et al. teaches a schematic representation of the DNA conformation (position, length, and packing density) associated with different operating conditions (i.e., wherein the biopolymer property includes a conformation) (Pg. 5, Fig. 4). Zhou et al. further teaches that extrapolation of the experimental electric field data results in the characteristic threshold electric field strength, E0 (normalized to the threshold electric field strength measured in the absence of a nanofunnel E0 (no funnel)) for three nanofunnels.
τ
0
= 6 ms corresponds to the Zimm relaxation time of the leading portion (~3000 bp) of the nanofunnel-confined molecule (i.e., wherein the biopolymer property includes a relaxation time) (Pg. 4, Fig. 3).
Regarding claim 11, Zhou et al. teaches the transport of single DNA molecules through nanochannels (i.e., wherein the biopolymer is DNA) (Abstract).
Regarding claim 13, Zhou et al. teaches that DNA molecules are stably trapped and axially positioned within a nanofunnel at sub-threshold electric field strengths (i.e., the translocation velocity is reduced when trapping the molecules; wherein the biopolymer property includes a biopolymer translocation velocity) (Abstract).
Regarding claim 15, Zhou et al. teaches that stable DNA can be trapped in a nanofunnel using applied electric fields. For example, measured values of various combinations of end coordinates for a T4-phage DNA molecule trapped at the representative nanochannel electric fields of 8 V/cm and 21 V/cm are shown in Fig. 4b and c, respectively (i.e., the biopolymer translocation velocity is reduced with certain applied electric fields; characterizing a relationship between the biopolymer translocation velocity and one or more operational conditions of the fluid flow and/or the fluid channel) (Pg. 5, Col. 1, Para. 1-2, and Pg. 5, Fig. 4).
Regarding claim 16, Zhou et al. teaches that by incorporating a three-dimensional nanofunnel at the nanochannel entrance, DNA can be more efficiently introduced into the nanochannel without an increase in the nanochannel electric field (i.e., driving the fluid flow by an external electric field) (Pg. 2, Col. 2, Para. 2). Zhou et al. further teaches that the DNA backbone is further surrounded by a cloud of uncondensed counterions (cations) localized within the double layer, delimited by the Debye length of the solution. The electrostatic force acting on the counterions drives them from the narrow end to the wide end of the nanofunnel, in the direction opposite to the force acting on the polyanionic DNA molecule (i.e., causing migration of ions in the fluid medium) (Supplementary Information, Pg. 15, Para. 2).
Regarding claim 21, Zhou et al. teaches that the position of a molecule's leading end within a nanofunnel was measured at three different nanochannel electric field strengths: 77.5V/cm, 54.3 V/cm, and 15.5 V/cm (i.e., wherein the one or more operational conditions of the fluid flow and/or the fluid channel include an electric field strength) (Pg. 3, Fig. 2).
Regarding claim 22, Zhou et al. teaches that the molecule's elasticity that resists its stretching is another contributor to the entropic force that was included in the calculations (i.e., wherein the biopolymer property includes an elastic response) (Pg. 7, Col. 1, Para. 2).
Zhou et al. does not teach predicting a fluid flow velocity and/or a fluid flow pressure of the fluid medium in response to the dimensional representation of the molecule concentration over time within the fluid medium including dye molecules using a machine learning model without direct imaging of the biopolymer dynamics (claim 1); and wherein the machine learning model is a physics-informed neural network model (claim 9).
Regarding claims 1, 17, and 19, Zeng et al. teaches a method to predict fluid velocity in a microfluidic channel using a deep neural networks assisted scaler image velocimetry (DNN-SIV) (Abstract). Zheng et al. further teaches that the predicted velocity is time dependent (Pg. 4, Para. 2). Zeng et al. further teaches that the model can use a representative shape of a microchannel, as shown in Fig. 1. Fig. 1 shows a schematic of the microchannel, and does not include any imaging of biopolymers. The channel can also include fluorescent dyes or fluorescent protein molecules (i.e., predicting a fluid flow velocity and/or a fluid flow pressure of the fluid medium in response to the dimensional representation of the molecule concentration over time within the fluid medium including dye molecules using a machine learning model without direct imaging of the biopolymer dynamics) (Pg. 3, Para. 3-4 and Pg. 4, Fig. 1).
Regarding claim 9, Zeng et al. teaches that the deep neural networks assisted scalar image velocimetry (DNN-SIV) is built on physics-informed neural networks and residual neural networks that integrate data of scalar field and physics laws (i.e., wherein the machine learning model is a physics-informed neural network model) (Abstract).
Therefore, regarding claims 1-6, 8-11, 13, 15-16, and 21-22, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of analyzing DNA translocation through nanochannels of Zhou et al. with the machine learning algorithm to predict fluid velocity of Zeng et al. because the algorithm of Zeng et al. is more stable, efficient, and allows for real-time flow visualization (Zeng et al., Abstract and Pg. 11, Para. 2). One of ordinary skill in the art would be able to combine the teachings of Zhou et al. with Zeng et al. with reasonable expectation of success due to the same nature of the problem to be solved, since both are drawn towards a method for analyzing fluid flow in channels. Therefore, regarding claims 1-6, 8-11, 13, 15-16, and 21-22, the instant invention is prima facie obvious (MPEP § 2142).
2. Claims 7, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. in view of Zheng et al., as applied to claims 1-6, 8-11, 13, 15-16, and 21-22 above, and further in view of He et al.(Salt-Gradient Approach for Regulating Capture-to-Translocation Dynamics of DNA with Nanochannel Sensors. ACS Sens. 1(6): 807-816 (2016); published 05/18/2016; newly recited).
This rejection is newly recited and necessitated by claim amendment.
Zhou et al. in view of Zeng et al., as applied to claims 1-6, 8-11, 13, 15-16, and 21-22 above, does not teach wherein the one or more operational conditions of the fluid flow and/or the fluid channel include a salt concentration and/or a fluid channel wall surface treatment (claim 7); wherein the one or more operational conditions of the fluid flow channel and/or the fluid channel include a fluid channel wall surface treatment (claim 12); and wherein the one or more operational conditions of the fluid flow and/or the fluid channel include a salt concentration (claim 14).
Regarding claim 7, He et al. teaches a model for regulating DNA motion in nanochannels based on control of the hydrodynamic flow via the salt gradient (Abstract). He et al. further teaches that in the modeling of the salt-concentration-based nanochannel system, there is a larger concentration of imposed salt at one end of the channel. At that end, counterions for screening the channel-wall surface charges are piled more densely and thus the electrical double layers are thinner there. The situation then reverses for the smaller concentration at the other end of the channel (Pg. 808, Fig. 1). Changing the salt gradient can also be used to regulate DNA motion for the purpose of nanopore sequencing (i.e., wherein the one or more operational conditions of the fluid flow and/or the fluid channel include a salt concentration) (Pg. 809, Fig. 3 and Pg. 814, Col. 2, Para. 2). He et al. further teaches the channel-wall surface charges are negatively charged and the density of the charges on the channel wall surface is controlled in the modeling (i.e., wherein the one or more operational conditions of the fluid flow and/or the fluid channel include a fluid channel wall surface treatment) (Pg. 808, Fig. 1; Pg. 809, Fig. 3; and Pg. 809, Col. 1, Para. 1).
Regarding claim 12, He et al. teaches the limitation of wherein the one or more operational conditions of the fluid flow channel and/or the fluid channel include a fluid channel wall surface treatment as described for claim 7 above.
Regarding claim 14, He et al. teaches the limitation of wherein the one or more operational conditions of the fluid flow and/or the fluid channel include a salt concentration as described for claim 7 above.
Therefore, regarding claims 7, 12, and 14, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of analyzing DNA translocation through nanochannels of Zhou et al. in view of Zeng et al. with the operational conditions of He et al. because the method of He et al. provides a protocol to overcome the key hurdle of tailoring the capture-to-translocation dynamics of polynucleotides for nanopore sequencing (He et al., Abstract). One of ordinary skill in the art would be able to combine the teachings of Zhou et al. in view of Zeng et al. with He et al. with reasonable expectation of success due to the same nature of the problem to be solved, since both are drawn towards a method for regulating translation of DNA through nanochannels. Therefore, regarding claims 7, 12, and 14, the instant invention is prima facie obvious (MPEP § 2142).
Response to Arguments under 35 U.S.C. 103
Applicant’s arguments filed 05/29/2026 have been fully considered but they are not persuasive.
1. Applicant argues that the cited references do not disclose or suggest the claimed predicting step. Rather, Zhou and Benninger image DNAs labeled with dye. In contrast, the claimed predicting step dye molecules are imaged to predict properties of biopolymers without direct imaging. For instance, Zhou uses Yo Yo-1 but Zhou images Yo Yo-1 attached to DNA, not free Yo Yo-1 dyes in solution. Zeng does not cure the defective teachings of Zhou and Benninger. For at least these reasons, Applicant urges that claims 1-16 are patentable over the cited art (Applicant’s Remarks, Pg. 10).
It is respectfully submitted that this is not persuasive for the following reasons:
As described in the rejection above, the predicting step recited in claim 1, “predicting a fluid flow velocity and/or a fluid flow pressure of the fluid medium in response to the dimensional representation of the molecule concentration over time within the fluid medium including dye molecules using a machine learning model without direct imaging of the biopolymer dynamics”, is taught by Zeng et al. Specifically, Zeng et al. discloses the predicting step, including the amendments to include dye molecules and without the direct imaging of biopolymer dynamics. Neither Zhou et al. nor Benninger et al. is relied upon to disclose the claimed predicting step. Additionally, the claim recites “including dye molecules”, which does not require free dyes in solution. Therefore, Zhou et al. in view of Zeng et al. discloses all of the amended limitations in claim, as described in the rejection above. This argument is thus not persuasive.
Conclusion
No claims allowed.
Claims 17-20 appear to be free from the prior art because the prior art does not fairly suggest or teach receiving a dimensional representation of a buffer solution containing two dye molecules, where the molecular concentration is an aggregate concentration of the two dye molecules. The closest prior art is Zhou et al. (Enhanced nanochannel translocation and localization of genomic DNA molecules using three-dimensional nanofunnels. Nat Commun 8, 807 (2017); previously cited). Zhou et al. discloses a method to control and transport DNA molecules through a nanoscale channel, including an intercalating dye (Abstract and Pg. 6, Col. 2, Para. 3). Zhou et al. further discloses the characterization of the biopolymer property (Pg. 3, Fig. 2c; and Pg. 5, Fig. 4b/c) and the operation of the fluid channel by controlling the motion of the biopolymer (Pg. 5, Col. 2, Para. 1). However, Zhou et al. does not teach “receiving a dimensional representation of a molecule concentration over time within a fluid flow of a buffer solution of dye molecules including a first dye molecule type having a first diffusion property and a second dye molecule type having a second diffusion property different than the first diffusion property, the buffer solution flowing through the fluid channel including a biopolymer, the molecular concentration is an aggregate concentration of the first and second dye molecule types”, as disclosed in instant claims 17 and 19. Claims 18 and 20 appear to be free from the prior art due to their dependency on claims 17 and 19.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/D.P.S./Examiner, Art Unit 1687
/Lori A. Clow/Primary Examiner, Art Unit 1687
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