DETAILED ACTION
The Applicant’s filing, received 27 May 2022 has been fully considered. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
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 1-3, 5-11, and 13-20 are pending.
Claims 1-3, 5-11, and 13-20 are rejected.
Priority
This application is a 371 of PCT/CN2019/122068, filed 29 November 2019.
Therefore, the effective filing date of the claimed invention is 29 November 2019.
Drawings
The drawings were received 27 May 2022. These drawings are acceptable.
Information Disclosure Statement
The information disclosure statements (IDS) received 31 May 2022 and 22 September 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, these information disclosure statements have been considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
a random emulsification processing module configured to… in claim 9;
an amplification processing module configured to… in claim 9;
an image acquisition module configured to… in claim 9;
an image analysis module configured to… in claims 9 and 11;
a determination module configured to… in claim 9;
a deformation processing module configured to… in claim 10;
a simulation system configured to… in claims 14, 15, and 16;
a first setting module configured to… in claim 14;
a data generation module configured to… in claims 14 and 15;
a first calculation module configured to… in claim 14;
a generation module configured to… in claim 14;
a representation module configured to… in claim 14;
a first determination module configured to… in claim 14;
a counting module configured to… in claim 14;
a second determination module configured to… in claim 14;
a verification module configured to… in claim 14; and
a second setting module configured to… in claim 15.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The written description discloses a corresponding structure for the non-structural generic placeholder:
an image acquisition module configured to… in claim 9 at para. [0064] in the Specification (a camera (a charge-coupled device (CCD) image sensor or a complementary metal-oxide-semiconductor (CMOS) image sensor), an excitation light source, a lens group, a beam splitter, a filter module, etc.);
an image analysis module configured to… in claims 9 and 11 may be comprised of instructions (reference #104 in FIG. 1) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00148] (analyze image regions, corresponding to the respective reaction zones…) and at para. [00185] (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a determination module configured to… in claim 9 may be comprised of instructions (reference #105 in FIG. 1) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00149] (determine, based on the total number of the reaction zones or droplets, the volume information…) and at para. [00185] (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a simulation system configured to… in claims 14, 15, and 16 may be comprised of instructions (reference #401 through #409 in FIG. 4) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at paras. [00161] – [00169] (algorithm for simulating formation of a zone with any size or dispersed droplets with any volume for achieving calculation of digital absolute quantitative testing) and at para. [00185] (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a first setting module configured to… in claim 14 may be comprised of instructions (reference #401 in FIG. 4) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00161] (set the total number of target molecules) and at para. [00185] (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a data generation module configured to… in claims 14 and 15 may be comprised of instructions (reference #402 in FIG. 4) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00162] (generate…volume values) and at para. [00185] (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a first calculation module configured to… in claim 14 may be comprised of instructions (reference #403 in FIG. 4) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00163] (calculate…the total volume of the fluid system to be quantified) and at para. [00185] in the Specification (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a generation module configured to… in claim 14 may be comprised of instructions (reference #404 in FIG. 4) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00164] (generate…m groups of coordinate numerical value sets) and at para. [00185] in the Specification (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a representation module configured to… in claim 14 may be comprised of instructions (reference #405 in FIG. 4) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00165] (represent…the volume value of each reaction zone or droplet) and at para. [00185] in the Specification (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a first determination module configured to… in claim 14 may be comprised of instructions (reference #406 in FIG. 4) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00166] (determine the number of coordinate numerical values contained in each of the numerical value intervals) and at para. [00185] in the Specification (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a counting module configured to… in claim 14 may be comprised of instructions (reference #407 in FIG. 4) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00167] (count the total number of numerical value intervals containing zero coordinate numerical value) and at para. [00185] in the Specification (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a second determination module configured to… in claim 14 may be comprised of instructions (reference #408 in FIG. 4) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00168] (determine…the total number of the reaction zones or droplets) and at para. [00185] in the Specification (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC));
a verification module configured to… in claim 14 may be comprised of instructions (reference #409 in FIG. 4) executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00169] (compare whether the set total number of the target molecules and the estimated value of the total number of the target molecules are within a preset error range) and at para. [00185] in the Specification (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC)); and
a second setting module configured to… in claim 15 may be comprised of instructions executable by a processor (reference #1002 in FIG. 15); e.g., see Specification at para. [00171] (set parameter information of a preset distribution with which the volumes of the reaction zones or droplets comply) and at para. [00185] in the Specification (the processor may be a Central Processing Unit (CPU), or an Application Specific Integrated Circuit (ASIC)).
The written description does not disclose a corresponding structure for the non-structural generic placeholder:
a random emulsification processing module configured to… in claim 9;
an amplification processing module configured to… in claim 9; and
a deformation processing module configured to… in claim 10.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recites sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 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 9, 10, 11, and 13 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.
Claim 9 recites the limitations “a random emulsification processing module configured to…” and “an amplification processing module configured to…,” however the disclosure does not clearly link any structure for the “random emulsification processing module” or for the “amplification processing module” as required by MPEP 2181. For example, the disclosure describes a function of the “random emulsification processing module” (e.g., at para. [0015]) and the disclosure describes a function of the “amplification processing module” (e.g., at para. [00146]), but does not link any structure to the functions.
Claims 10, 11, and 13 are rejected for depending from claim 9 and failing to remedy the failure of claim 9 to comply with the written description requirement.
Claim 10 recites the limitation “a deformation processing module configured to…,” however the disclosure does not clearly link any structure for the “deformation processing module” as required by MPEP 2181. For example, the disclosure describes a function of the “deformation processing module” (e.g., at para. [00151]), but does not link any structure to the functions.
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, 2, 3, 5, 9, 10, 11, 13, 17, 19, and 20 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.
The claim limitations “a random emulsification processing module configured to…” and “an amplification processing module configured to…” (claim 9) and “a deformation processing module configured to…” (claim 10) invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. For example, the disclosure describes a function of the “random emulsification processing module” (e.g., at para. [0015]) and the disclosure describes a function of the “amplification processing module” (e.g., at para. [00146]), and the disclosure describes a function of the “deformation processing module” (e.g., at para. [00151]), but the disclosure does not link any structures to the functions. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 1 recites the limitation "the total number of…" in line five. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 is further indefinite for reciting “acquiring… images of the reaction zones or droplets to obtain a target image” in lines 11-12, because it is not clear as to whether “a target image” comprises a plurality of acquired “images” or alternatively if “a target image” is one image selected from amongst a plurality of acquired “images.”
Claim 1 recites the limitation "the respective reaction zones or droplets" in line thirteen. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the Poisson binomial distribution" in line 24. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 provides a relationship, and it is unclear why the value ‘m’ is not represented as something to be calculated, rather is provided a possible variable in two places. Further, the claim provides a parenthetical and it is unclear if the values are examples or if the claim is limited to only whole values or what it is limited to. Finaly, the relationship contains variables which the method step is intended to provide, for example qth as a droplet that does not contain a target, and ‘e’ as a natural constant is undefined, and it is unclear what ‘natural’ is intended to limit.
Claims 2, 3, and 5 are indefinite for depending from claim 1 and for failing to remedy the indefiniteness of claim 1.
Claim 5 recites the limitation "the preset amplification system" in line two. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 is further indefinite for reciting "the preset amplification system" because the claim recites a system as well as method steps of using the system, i.e., amplification processing of the reaction zones or droplets. See MPEP 2173.05(p) II.
Claim 9 recites the limitation "the total number of…" in line six. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 is further indefinite for reciting “acquire images of the reaction zones or droplets to obtain a target image” in lines 14-15, because it is not clear as to whether “a target image” comprises a plurality of acquired “images” or alternatively if “a target image” is one image selected from amongst a plurality of acquired “images.”
Claim 9 recites the limitation "the respective reaction zones or droplets" in lines 16-17. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the Poisson binomial distribution" in line 27. There is insufficient antecedent basis for this limitation in the claim.
Claims 10, 11, and 13 are indefinite for depending from claim 9 and for failing to remedy the indefiniteness of claim 9.
Claim 13 recites the limitation "the preset amplification system" in line two. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 is further indefinite for reciting "the preset amplification system" because the claim recites a system as well as method steps of using the system, i.e., amplification processing of the reaction zones or droplets. See MPEP 2173.05(p) II.
Claim 17 recites the limitation "the processor" in lines two and three. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the processor" in lines two and three. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the calculation method" in line five. There is insufficient antecedent basis for this limitation in the claim, because claim 6 recites a “simulation method for simulating formation of….”
Claim 20 recites the limitation "the calculation method" in lines two and three. There is insufficient antecedent basis for this limitation in the claim, because claim 6 recites a “simulation method for simulating formation of….”
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 1-3, 5-11, and 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mathematical concepts, (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgement, opinion).
Subject matter eligibility evaluation in accordance with MPEP 2106.
Eligibility Step 1: Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter?
Claims 1-3 and 5 recite a quantitative analysis method (i.e., a process); claims 6-8 recite a simulation method (i.e., a process); claims 9-11 and 13 recite a quantitative analysis device (i.e., a machine or manufacture); claims 14-16 recite a simulation system (i.e., a machine or manufacture); claim 17 recites an electronic device comprising a memory and a processor (i.e., a machine or manufacture); and claim 19 recites an electronic device comprising a memory and a processor (i.e., a machine or manufacture).
Therefore, these claims are encompassed by the categories of statutory subject matter, and thus, satisfy the subject matter eligibility requirements under step 1.
[Step 1: YES]
Claims 18 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because:
the claims are directed to a computer-readable storage medium that is not limited to non-transitory media, and therefore these claims comprise an embodiment that is a signal per se, because the broadest reasonable interpretation of the claims does not require the CRM to be limited to non-transitory media, and therefore could comprise transitory media, e.g., carrier waves, which are not patent eligible.
This rejection at Step 1 may be overcome by amending the claimed subject matter to be limited to a “non-transitory computer-readable storage medium” computer-readable storage medium” (see MPEP 2106.03I.). However, amending the claims to recite a “non-transitory computer-readable storage medium” would not overcome a rejection at Step 2A or Step 2B, for the reasons noted below.
[Step 1: NO]
However, in the interest of compact prosecution, claims 18 and 20 are examined herein with respect to whether the claims are directed to an abstract idea without significantly more.
Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.
Independent claims 1, 9, 17, and 18 recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
analyzing image regions, corresponding to the respective reaction zones or droplets, in the target image to obtain volume information of the respective reaction zones or droplets; determining presence of target molecules to be tested in the reaction zones or droplets; and counting the number of reaction zones or droplets that do not contain the target molecules (i.e., analyzing images for presence or absence of target molecules and determining corresponding counts, which comprise performing mental processes and/or mathematical concepts);
determining, based on the total number of the reaction zones or droplets, the volume information of the respective reaction zones or droplets, the presence of the target molecules to be tested in the reaction zones or droplets and the number of the reaction zones or droplets that do not contain the target molecules, the total number of the target molecules in the sample to be tested (i.e., analyzing images for presence or absence of target molecules and determining corresponding counts, which comprise performing mental processes and/or mathematical concepts);
the number of the reaction zones or droplets that do not contain the target molecules complies with the Poisson binomial distribution, and wherein the total number of the target molecules in the sample to be tested is determined according to the following formula:
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(i.e., analyzing data according a distribution of values using an equation, which comprises performing mental processes and/or mathematical concepts).
Independent claims 6, 14, 19, and 20 recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
setting the total number of target molecules to be m, wherein m is an integer greater than or equal to 0 (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts);
setting the total number of reaction zones or droplets to be n, and generating, based on the set total number n of the reaction zones or droplets, volume values vi respectively corresponding to the n reaction zones or n droplets, wherein vi, represents a volume value of an ith reaction zone or droplet, / = 1,2,3, ..., n, wherein n is an integer greater than 1 (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts);
calculating a total volume
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of a fluid system to be quantified based on the volume values respectively corresponding to the n reaction zones or n droplets (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts);
randomly generating m groups of coordinate numerical value sets based on the total volume of the fluid system to be quantified, wherein a range of elements in the coordinate numerical value sets does not exceed the total volume
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of the fluid system to be quantified (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts);
representing, based on a dimension of each coordinate numerical value set, the volume value of each reaction zone or droplet as n numerical value intervals which have the dimension and are connected according to a preset sequence (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts);
determining the number of coordinate numerical values contained in each of the n numerical value intervals (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts);
counting the total number of numerical value intervals containing zero coordinate numerical value, and taking the obtained total number as the number Co of reaction zones or droplets that do not contain target molecules (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts);
determining, based on the total volume
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of the fluid system to be quantified, the total number n of the reaction zones or droplets, the volume value vi of the respective reaction zones or droplets and the number Co of the reaction zones or droplets that do not contain the target molecules, an estimated value M of the total number of the target molecules (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts); and
comparing whether the set total number m of the target molecules and the estimated value M of the total number of the target molecules are within a preset error range; and in response to being within the preset error range, determining that the simulation system is capable of performing calculation of digital absolute quantitative testing (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts).
Dependent claims 3, 7, 8, 11, 15, and 16 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below.
Dependent claims 3 and 11 further recite:
extracting features of the image regions, corresponding to the respective reaction zones or droplets, in the target image, to obtain feature information corresponding to each image region (i.e., generating a representation of particular visual characteristics which excludes extraneous image data, which comprises performing mental processes and/or mathematical concepts);
for each image region, matching the feature information of the image region with preset feature information; in response to that the feature information of the image region is not matched with the preset feature information, determining that the reaction zone or droplet corresponding to the image region does not contain the target molecules (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts); and
determining the total number of image regions, which are not matched with the preset feature information, in the target image, and taking the total number of the image regions as the number of the reaction zones or droplets that do not contain the target molecules (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts).
Dependent claims 7 and 15 further recite:
setting parameter information of a preset distribution with which the volumes of the reaction zones or droplets comply (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts); and
generating, based on the parameter information of the preset distribution and the set total number n of the reaction zones or droplets, the volume values respectively corresponding to the n reaction zones or n droplets (i.e., analyzing quantitative data, which comprises performing mental processes and/or mathematical concepts).
Dependent claims 8 and 16 further recite:
the preset distribution comprises Gaussian distribution, logarithmic Gaussian distribution, and uniform distribution, and wherein the parameter information comprises a mean, a standard deviation, and a variation coefficient (i.e., analyzing quantitative data according to its distribution, which comprises performing mental processes and/or mathematical concepts).
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. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pen and paper (e.g., analyzing image regions for presence or absence of target molecules), and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas (e.g., using statistical distribution equations to analyze count data) are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Therefore, claims 1-3, 5-11, and 13-20 recite an abstract idea.
[Step 2A Prong One: YES]
Eligibility 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); MPEP 2106.05(a-h)). 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 judicial exceptions identified in Eligibility Step 2A Prong One are not integrated into a practical application because of the reasons noted below.
Independent claim 6 and dependent claims 3, 7, and 8 do not recite any elements in addition to the judicial exception, and thus are part of the judicial exception.
The additional elements in independent claim 1 include:
performing random emulsification processing;
performing amplification processing on the reaction zones or droplets; and
acquiring, subsequent to that the amplification processing ends, images of the reaction zones or droplets to obtain a target image;
The additional elements in independent claim 9 include:
a random emulsification digital absolute quantitative analysis device (i.e., a processor);
a random emulsification processing module;
an amplification processing module;
an image acquisition module;
an image analysis module (i.e., a processor); and
a determination module (i.e., a processor).
The additional elements in independent claim 14 include:
a simulation system (i.e., a processor);
a first setting module (i.e., a processor);
a data generation module (i.e., a processor);
a first calculation module (i.e., a processor);
a generation module (i.e., a processor);
a representation module (i.e., a processor);
a first determination module (i.e., a processor);
a counting module (i.e., a processor);
a second determination module (i.e., a processor); and
a verification module (i.e., a processor).
The additional elements in independent claim 17 include:
an electronic device comprising a memory and a processor; and
the additional elements in independent claim 1 as noted above.
The additional elements in independent claim 18 include:
a computer-readable storage medium;
a processor; and
the additional elements in independent claim 1 as noted above.
The additional elements in independent claim 19 include:
an electronic device comprising a memory and a processor.
The additional elements in independent claim 20 include:
an electronic device comprising a memory and a processor.
The additional elements in dependent claims 2, 5, 10, 11, 13, 15, and 16 include:
performing squeezing deformation processing on each amplified reaction zone or droplet (claim 2);
a device (i.e., a processor) and a deformation processing module configured to perform squeezing deformation processing on each amplified reaction zone or droplet (claim 10);
the preset amplification system comprises a preset indicator; during the amplification processing on the reaction zones or droplets, in response to detecting that an intensity of an indication signal of the preset indicator is no longer to change, it is determined that the amplification processing ends (claim 5);
a device (i.e., a processor) and image analysis module (i.e., a processor) (claim 11);
a device (i.e., a processor) and the preset amplification system comprises a preset indicator; during the amplification processing on the reaction zones or droplets, in response to detecting that an intensity of an indication signal of the preset indicator no longer changes, it is determined that the amplification processing ends (claim 13);
a simulation system (i.e., a processor); a second setting module (i.e., a processor); and a data generation module (i.e., a processor) (claim 15); and
a simulation system (i.e., a processor) (claim 16).
The additional elements of a processor (claims 9-11 and 13-20); a memory (claims 17 and 19); and a computer-readable storage medium (claims 18 and 20); invoke a computer and/or computer-related components merely as tools for use in the claimed process, and therefore are not an improvement to computer functionality itself, or an improvement to any other technology or technical field, and thus, do not integrate the judicial exceptions into a practical application (MPEP 2106.04(d)(1)).
The additional elements of a random emulsification processing module (claim 9) for performing random emulsification processing (claim 1); an amplification processing module (claim 9) for performing amplification processing on the reaction zones or droplets (claim 1); an image acquisition module (claim 9) for acquiring, subsequent to that the amplification processing ends, images of the reaction zones or droplets to obtain a target image (claim 1); a deformation processing module (claim 10) for performing squeezing deformation processing on each amplified reaction zone or droplet (claim 2); and an automated amplification system (claims 5 and 13); are merely pre-solution activities that are steps in the process of gathering data for use in the claimed process – nominal additions to the claims that do not meaningfully limit the claims, and therefore do not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)).
Thus, the additionally recited elements merely invoke a computer and/or computer related components as tools; and/or amount to insignificant extra-solution activity; and as such, when all limitations in claims 1-3, 5-11, and 13-20 have been considered as a whole, the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 1-3, 5-11, and 13-20 are directed to an abstract idea (MPEP 2106.04(d)).
[Step 2A Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
Independent claim 6 and dependent claims 3, 7, and 8 do not recite any elements in addition to the judicial exception(s).
The additional elements recited in independent claims 1, 9, 14, and 17-20 and dependent claims 2, 5, 10, 11, 13, 15, and 16 are identified above, and carried over from Step 2A Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at Step 2A Prong Two was re-evaluated at Step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements were evaluated to determine whether any additional elements or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d).
The additional elements of a processor (claims 9-11 and 13-20); a memory (claims 17 and 19); and a computer-readable storage medium (claims 18 and 20); are conventional computer components and/or functions (see MPEP at 2106.05(b) and 2106.05(d)(II) regarding conventionality of computer components and computer processes).
The additional elements of a random emulsification processing module (claim 9) for performing random emulsification processing (claim 1); an amplification processing module (claim 9) for performing amplification processing on the reaction zones or droplets (claim 1); an image acquisition module (claim 9) for acquiring, subsequent to that the amplification processing ends, images of the reaction zones or droplets to obtain a target image (claim 1); a deformation processing module (claim 10) for performing squeezing deformation processing on each amplified reaction zone or droplet (claim 2); and an automated amplification system (claims 5 and 13); are conventional.
Evidence of conventionality is shown by:
Vladisavljevic et al. (2012). “Production of uniform droplets using membrane, microchannel and microfluidic emulsification devices.” Microfluidics and Nanofluidics, Vol. 13, pp. 151-178;
Gorgannezhad et al. (2019). “Microfluidic-Based Nucleic Acid Amplification Systems in Microbiology.” Micromachines, Vol. 10, No. 408, pp. 1-34;
Kalantarifard et al. (2018). “Label-Free Sensing in Microdroplet-Based Microfluidic Systems.” Chemosensors, Vol. 6, No. 23, pp. 1-28;
Quan et al. (2018). “dPCR: A Technology Review.” Sensors, Vol. 18, No. 1271, pp. 1-27;
Yin et al. (2019). “Integrated microfluidic systems with sample preparation and nucleic acid amplification.” Lab Chip, Vol. 19, No. 2769, pp. 2769-2785; and
Zhang et al. (2018). “Particle squeezing in narrow confinements.” Microfluidics and Nanofluidics, Vol. 22:120, pp. 1-26.
Vladisavljevic et al. (2012) reviews the production of uniform droplets using membrane, microchannel and microfluidic emulsification devices (Title; and Abstract) and shows that conventional devices for emulsification produce resulting droplets that are usually highly polydisperse (page 151, col. 2, para. 1) (i.e., a mixture of droplets that have a wide range of sizes, shapes, or molecular weights, rather than being uniform like a monodisperse sample where particles are nearly identical).
Gorgannezhad et al. (2019) reviews microfluidic-based nucleic acid amplification systems (Title) and shows microfluidic devices that are developed to integrate and automate the different analysis steps into a single device (page 10, Section 3.2., para. 1); and further shows real-time optical detection (page 15, Section 5.3.2.); and further shows various isothermal amplification-based devices and methods for nucleic acid amplification (e.g., loop-mediated isothermal amplification (LAMP), recombinase polymerase amplification (RPA), helicase-dependent amplification (HAD), and strand displacement amplification (SDA)) (page 11, bottom, and page 12, top); and specifically shows that the generation of an amplified target material is monitored in real-time by fluorescence (page 12, Section 5.1., para. 2; and Table 2); and further shows a polydisperse droplet emulsion approach with a statistical correction to overcome hurdles such as methods that are mostly limited to laboratories with trained personnel and expensive equipment, and that further overcomes the loss of data due to improper droplet size, since the polydisperse method allows for the measurement of droplets regardless of droplet size (page 20, para. 2).
Kalantarifard et al. (2018) reviews label-free sensing in microdroplet-based microfluidic systems (Title; and Abstract) and shows that the size of droplets and frequency of droplet generation can be modulated by channel geometry and tailoring the flow regime (squeezing) (Section 2.4.).
Quan et al. (2018) reviews dPCR (digital Polymerase Chain Reaction) technology (Title) and shows droplet-based platforms where emulsions can be easily and quickly obtained by mechanical shearing, which generates polydisperse droplets (page 14, Section 4.3., para. 2); and further shows that droplet dPCR assays can be multiplexed by coding the level of fluorescence of the plateau phase (Figure 10).
Yin et al. (2019) reviews integrated microfluidic systems with sample preparation and nucleic acid amplification (Title; and Abstract) and shows various fully automated nucleic acid diagnostic products that reduce user handling of samples by integrating sample preparation steps with PCR amplification and real-time fluorescence detection in the same cartridge (page 2779, col. 2, para. 4).
Zhang et al. (2018) reviews particle squeezing in narrow confinements (Title) and shows that many lab-on-a-chip applications require processing of droplets, cells, and particles using narrow confinements for the control of deformable droplets, and further shows that analytical methods used in studies of particle squeezing through narrow confinements span various fields of science and technology (Abstract).
Therefore, when taken alone, all additional elements in claims 1-3, 5-11, and 13-20 do not amount to significantly more than the above-identified judicial exception(s). Even when evaluated as a combination, the additional elements fail to transform the exception(s) into a patent-eligible application of that exception. Thus, claims 1-3, 5-11, and 13-20 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)).
[Step 2B: NO]
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.
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.
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.
Claims 1-3, 5-11, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chiu et al. (US 2017/0175174).
Chiu et al. is directed to methods and apparatus for performing digital assays using polydisperse droplets (Title) and further directed to methods, devices, and systems that can be used for the amplification and detection of nucleic acids, and that can be used for the recognition, detection, and sizing of droplets in a volume (Abstract).
Independent claims 1, 9, 17, and 18 broadly encompass the amplification and quantification of target molecules using emulsified droplets that are not monodisperse and that do not form uniformly sized zones.
Dependent claims 2, 3, 5, 10, 11, and 13 further define the process of determining the total number of the target molecules in the sample, e.g., droplet formation (claim 2); analyzing image data (claim 3); and monitoring the amplification process (claim 5).
Independent claims 6, 14, 19, and 20 broadly encompass a simulation method and system to perform the calculation of the absolute quantitative testing method to, e.g., evaluate the influence of the variation of the volumes of the zones on an absolute quantitative result.
Dependent claims 7, 8, 15, and 16 further define the simulation method of verifying the quantitative testing method, e.g., setting parameter information and generating model values (claim 7); and establishing statistical measures for analyzing the distributions of the target molecule values (claim 8).
Regarding independent claims 1, 9, 17, and 18, Chiu et al. shows methods, systems, compositions and kits for performing digital assays containing polydisperse droplets without the introduction of undue experimental error (para. [0010]); the methods, systems, compositions and kits can be used to perform digital PCR assays involving the amplification of a nucleotide sample and labeling the sample with a detectable agent (paras. [0011] & [0012]); obtaining an image stack for a droplet, and determining from the image stack the presence or absence of the detectable agent in the droplet, and then determining the concentration of the sample in the plurality of droplets based on the presence or absence of the detectable agent in a plurality of droplets (paras. [0012] & [0013]); and the sample is distributed into droplets of variable size and the distribution of target molecules into the droplets follows Poisson statistics (para. [0411]).
Chiu et al. does not show the exact equation for modeling a Poisson binomial distribution.
Regarding dependent claims 2, 3, 5, 10, 11, and 13, Chiu et al. shows using microfluidic channels and immiscible fluid phases to form discrete sample volumes that are defined by the geometric dimensions of the side cavities (para. [0084]); different feature extraction methods (e.g., paras. [0271] & [0272]); and a polydisperse droplet emulsion system and visualizing the presence of amplification products within a droplet (paras. [0404] & [0405]).
Chiu et al. does not show the exact equation(s) for simulating the calculations of the absolute quantitative testing method, and does not explicitly state that a fully automated droplet emulsion system is used.
Regarding independent claims 6, 14, 19, and 20, Chiu et al. shows computer simulations to validate methods for performing digital assays (paras. [0039] & [0040]) and in particular, simulating measurement variability of droplet diameters (para. [0422]).
Chiu et al. does not show the exact equations or steps in simulating the quantitative testing method.
Regarding dependent claims 7, 8, 15, and 16, Chiu et al. shows using equations to simulate sample concentration of target molecules (paras. [0447] & [0448]); and calculating the degree of confidence that samples have different concentrations by measuring the volume of each droplet and its associated error by approximating the error using a Gaussian-distributed error (paras. [0417] & [0418]); using measures of standard deviation and the mean of the estimated concentration distribution for calculating error in the simulated measurement of droplet diameters (para. [0422]).
Chiu et al. does not show the exact equations or steps in simulating the quantitative testing method.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method shown by Chiu et al. by incorporating alternative equations for calculating the statistical measures corresponding to molecule distributions and droplet characteristics, as shown by Chiu et al. and discussed above. One of ordinary skill in the art would have been motivated to modify the methods of Chiu et al. by using different equations for statistical analysis because Chiu et al. shows that volumes for droplets can be produced having a variety of volume distributions, which can be analyzed using a variety of different methods (e.g., at para. [0071]). This modification would have had a reasonable expectation of success given that Chiu et al. discloses methods for the generation of polydisperse droplets and subsequent analyses of droplet characteristics (e.g., diameter/volume) and determination of presence and absence of target molecules in droplets using image analysis techniques.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 3, 5, 9, 10, 11, 13, 17, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/272,128 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to the emulsification and generation of polydisperse droplets for subsequent determination of presence and/or absence of target molecules, and the reference application is directed to the emulsification and generation of polydisperse droplets for subsequent determination of presence and/or absence of target molecules.
Instant independent claims 1 and 9 and those claims dependent therefrom (i.e., 2, 3, 5, 10, 11, and 13), recite substantially the same limitations as the reference application independent claims 1 and 9 and those claims dependent therefrom (i.e., 2-8 and 10-15).
Instant independent claims 17 and 18 recite substantially the same limitations as the reference application independent claims 16-20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this application.
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/S.W.B./Examiner, Art Unit 1687
/Joseph Woitach/Primary Examiner, Art Unit 1687