DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 15 and 17-21 in the reply filed on 11/28/2025 is acknowledged.
Claims 1-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/28/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/25/2023, 05/24/2024 and 09/04/2024 are being considered by the examiner.
Drawings
The drawings are objected to because
Fig. 10 element 342, “First sample distribution device” should read “Second sample distribution device” (paras. 0098 and 0099).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
para. 0099, “concussion emulsifier” should read “oscillating emulsifier” (para. 00125);
para. 00106, “FIG. 14b shows that there are dense small droplets (the first sample a) … Some large droplets in the flow path14 in FIG. 14c are not included in the statistical data” should read “FIG. 13b shows that there are dense small droplets (the first sample a) … Some large droplets in the flow path14 in FIG. 13c are not included in the statistical data”;
para. 0065 states, “…microdroplet b is a micron-sized droplet (a diameter of the droplet is 10 mm to 50 mm” Para. 00107 states, “Referring to FIG. 14, which is an image of microdroplets (microdroplets b)…”is not consistent with the image of Fig. 14; and
para. 00123 states “FIG. 15 is a fluorescence image of DNA nanospheres (with a diameter of about 200 nm)” is not consistent with the nanospheres shown in Fig. 15 which has nanospheres of around 50 mm.
Appropriate correction is required.
Claim Objections
Claim 15 is objected to because of the following informalities:
the indentations are off. For instance, line 2 (a liquid inlet and outlet device applying flow cell) should have the same level of indentation as line 20 (a first sample distribution device), line 22 (a second sample distribution device), and line 24 (an optical imaging unit); and line 3 (a flow cell) should have the same level of indentation as line 17 “first joint device” and line 18 “second joint device, etc.
Appropriate correction is required.
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 limitation(s) is/are:
“first sample distribution device configured to inject the first sample into the flow cell through the first joint device” in claim 15;
“second sample distribution device configured to form microdroplets from the second sample, and inject the microdroplets into the flow cell through the second joint device” in claim 15;
“cleaning unit” in claim 21;
“second sealing member” in claim 29; and
“first sealing member” in claim 32.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/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 limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In this instant case,
“first sample distribution device configured to inject the first sample into the flow cell through the first joint device” in claim 15 does not have a corresponding structure. See 35 U.S.C. 112 rejections below;
“second sample distribution device configured to form microdroplets from the second sample, and inject the microdroplets into the flow cell through the second joint device” in claim 15 has a corresponding structure of a microfluidic droplet generator or a oscillating emulsifier (para. 0099) and equivalents thereof for the function of forming microdroplets, but does not have a corresponding structure for injecting the microdroplets into the flow cell. See 35 U.S.C. 112 rejections below;
“cleaning unit” in claim 21 does not have a corresponding structure (0130). See 35 U.S.C. 112 rejections below;
“second sealing member” in claim 29 has a corresponding structure of elastomer (para. 0083) and equivalents thereof; and
“first sealing member” in claim 32 a corresponding structure of elastomer and equivalents thereof (para. 0083).
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 15 and 17-33 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.
Regarding claim 15, claim 15 recites the limitations “first sample distribution device configured to inject the first sample into the flow cell through the first joint device” and ”second sample distribution device configured to form microdroplets from the second sample, and inject the microdroplets into the flow cell through the second joint device.” 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. The disclosure is silent on what structure contributes to “to inject the first sample into the flow cell through the first joint device” and “inject the microdroplets into the flow cell through the second joint device.” The disclosure appears to disclose that upstream pump 35 is responsible for these functions; however upstream pump 35 is a separate structure, not a part of sample distribution device 341 or 342 according to para. 00110 in the specification and Fig. 10. Therefore, the disclosure is devoid of any structure of a “first sample distribution device” or a ”second sample distribution device” that performs the functions in the claim. The examiner notes that the specification discloses a microfluidic droplet generator or oscillating emulsifier (paras. 0099 and 00125) to form microdroplets from the second sample.
Claims 17-33 are rejected because of their dependency on claim 15
Regarding claim 21, claim 21 recites “cleaning unit.” 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. The disclosure is silent on what structure contributes to the function of “cleaning.” The disclosure appears to disclose the cleaning unit can hold and dispense cleaning agent (para. 00130), but fails to disclose any structure to perform the stated function of cleaning. Therefore, the disclosure is devoid of any structure of a “cleaning unit” that performs the functions in the claim.
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 15 and 17-33 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.
Claim limitations “first sample distribution device configured to inject the first sample into the flow cell through the first joint device” of claim 15, ”second sample distribution device configured to form microdroplets from the second sample, and inject the microdroplets into the flow cell through the second joint device” of claim 15, and “cleaning unit” of claim 21 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. The disclosure is silent on what structure contributes to “to inject the first sample into the flow cell through the first joint device” and “inject the microdroplets into the flow cell through the second joint device.” The disclosure appears to disclose that upstream pump 35 is responsible for these functions; however upstream pump 35 is a separate structure, not a part of sample distribution device 341 or 342 according to para. 00110 in the specification and Fig. 10. The examiner notes that the specification discloses a microfluidic droplet generator or oscillating emulsifier (paras. 0099 and 00125) to form microdroplets from the second sample. In addition, The disclosure is silent on what structure contributes to “cleaning.” The disclosure appears to disclose the cleaning unit can hold and dispense cleaning agent (para. 00130), but fails to disclose any structure to perform the stated function of cleaning. Therefore, claim 15 and 21 are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claims 17-33 are indefinite because of their dependency on claim 15
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 Rejections - 35 USC § 103
Claims 15 and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Leblanc et al. (US 20120244043 A1).
Regarding claim 15, Leblanc teaches a sample analysis system (the device shown in Figs. 8-16) comprising:
a liquid inlet and outlet device applying flow cell (see also annotated Fig. A below) comprising:
a flow cell comprising:
a first cover (microfluidic chip which is top and bottom plates bonded together)(paras. 0116, 0125, 0129);
a second cover (carrier top) facing the first cover;
a spacer (first gasket)(para. 0126) provided between the first cover and the second cover, wherein both sides of the spacer are in contact with the first cover and the second cover (Fig. 9B); a detection surface (the channel surface of the bottom plate)(“detection” is interpreted as an intended use. the channel surface on the bottom plate) is formed on a surface of the first cover near the second cover (para. 0116, the channel surface of the bottom is part of the first cover and is near the carrier top);
a first opening (the middle inlet port, see annotated Fig. A; or alternatively the opening at the carrier top corresponds to the middle inlet), wherein the first opening is configured to inject a first sample into the flow cell (interpreted as a functional limitation. first sample is not positively recited. Moreover, Fig. 9B, the first opening is configured for a sample to be injected into the flow cell), causing the first sample to be adsorbed on the detection surface (interpreted as an intended use. the first sample is not positively recited. a first sample can be adsorbed on the detection surface); and
a second opening (the left inlet port, see annotated Fig. A; alternatively the opening at the carrier top corresponds to the middle inlet), wherein the second opening is configured to inject microdroplets into the flow cell (para. 0096, “The inlet module generally comprises a junction between the sample inlet channel and the main channel such that a solution of a sample … is introduced to the main channel and forms a plurality of droplets”), and the microdroplets comprise a second sample;
a first joint device (tubing and the corresponding plastic chip port)(annotated Fig. A); and
a second joint device (pipette tip and the corresponding plastic chip port)(annotated Fig. A), wherein the first joint device is connected to the first opening, and the second joint device is connected to the second opening (annotated Fig. A);
a first sample distribution device (pipette)(para. 0096) configured to inject the first sample into the flow cell through the first joint device; and
an optical imaging unit (microscope)(para. 0042) configured to capture an image of the flow cell (microchip)(paras. 0042 and 0150).
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Figure A. Annotated Fig. 9B of Leblanc.
Leblanc teaches the first gasket (spacer) has three bosses for the three inlet ports (para. 0126) and thus fails to teach at least two spacers provided side by side between the first cover and the second cover, wherein both sides of each of the at least two spacers are in contact with the first cover and the second cover.
However, Leblanc teaches the a gasket with bosses configured to fit within the inlet ports for reliable sealing. Leblanc further the gaskets can contain different number for bosses (para. 0109, Figs. 7B and 8)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the first gasket taught by Leblanc in the embodiment of Fig. 8-16 with three gaskets each with one boss for the each inlet port because one of ordinary skill in the art would accordingly have recognized the whether one gasket with three bosses or three gaskets each with one boss would result in the predictable result of providing a gasket boss for each port for reliable sealing required for the inlet ports (para. 0109, Figs. 7B and 8A-C).
The teachings of modified would yield at least two spacers (the gasket with a boss for inlet port in the middle and a gasket with a boss for inlet port on the left) provided side by side between the first cover and the second cover, wherein both sides of each of the at least two spacers are in contact with the first cover and the second cover.
In addition, modified Leblanc teaches the first opening and the seconding opening are not in fluid communication with each other, and thus fails to teach the first cover, the second cover, and adjacent two of the at least two spacers cooperatively form a flow path. Consequently, modified Leblanc fails to the first opening arranged at an end of the flow path, wherein the first opening is configured to inject a first sample into the flow path, and the second opening arranged at another end of the flow path, wherein the second opening is configured to inject microdroplets into the flow path.
However, Leblanc teaches that the inlet channel from different inlet ports can be fluidically connected to through the main channel (para. 0096).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first opening and the second opening taught by Leblanc to have a flow path that connect to each other (para. 0096) in order to have two different fluids to coalesce or react within the device with a reasonable expectation of success (para. 0096)(MPEP 2143)(I)(G).
The teachings of modified Leblanc would yield the first cover (microfluidic chip), the second cover (carrier top), and adjacent two of the at least two spacers (the gaskets for the left and middle inlet ports) cooperatively form a flow path (the flow path that connects the left and middle inlets), as well as the first opening arranged at an end of the flow path, wherein the first opening is configured to inject a first sample into the flow path and the second opening (the left inlet port) arranged at another end of the flow path, wherein the second opening is configured to inject microdroplets into the flow path.
In addition, Leblanc fails to explicitly a second sample distribution device configured to form microdroplets from the second sample, and inject the microdroplets into the flow cell through the second joint device.
However, Leblanc teaches droplets of a sample fluid can be formed within the inlet module on the microfluidic device or droplets can be formed before the sample fluid is introduced to the microfluidic device ("off chip" droplet formation)(para. 0082).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analysis system taught by Leblanc with a droplet generating device (a second sample distribution device) connected to the tubing of left inlet port in order for droplets to be formed before the sample fluid is introduced to the microfluidic device with a reasonable expectation of success (para. 0082)(MPEP 2143)(I)(G).
Regarding claim 21, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 15.
Modified Leblanc does not teach a cleaning unit connected to the flow cell.
However, Leblanc teaches the microfluidic device can comprise a waste module (para. 0041)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Leblanc to include a waste module connected to the flow cell in order to accommodate waste (para. 0041).
The teachings of modified Leblanc would yet teach a cleaning unit connected to the flow cell, see also 35 U.S.C. 112(b).
Regarding claim 22, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 15.
Modified Leblanc does not explicitly teach wherein a hydraulic radius of the first opening is smaller than a hydraulic radius of the second opening.
However, Leblanc teaches wherein the port sizes are result-effective variable. Specifically, Leblanc teaches that a port size is customized based on the type of transport mechanism, e.g. various pipette tips or various size or tubing (para. 0111 and Fig. 5). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). In addition, Leblanc teaches the device is for analyzing different types of samples (molecules, cells, small molecules or particles), and thus different transport mechanisms may be use for the different inlet port in order to accord different sample type.
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the hydraulic radius of the first opening and the hydraulic radius of the second opening of Leblanc such that the hydraulic radius of the first opening is smaller than the hydraulic radius of the second opening because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Regarding claim 23, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 15. Leblanc teaches wherein the detection surface is further formed on a surface of the second cover near the first cover (“detection” is interpreted as an intended use. Surface on of the second cover meets the structural limitation of the intended use).
Regarding claim 24, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 22.
Modified Leblanc fails to teach wherein the hydraulic radius of the first opening is 0.075 mm to 0.75 mm.
Leblanc teaches wherein the port sizes (the hydraulic radius of the first and hydraulic radius second opening) are result-effective variables. Specifically, Leblanc teaches that the port size is customized based on the type of transport mechanism, e.g. various pipette tips or various size or tubing (para. 0111 and Fig. 5). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). In addition, Leblanc teaches the device is for analyzing different types of samples (molecules, cells, small molecules or particles), and thus different transport mechanisms may be use for the different inlet port in order to accord different sample type.
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the hydraulic radius of the first opening of Leblanc to be 0.075 mm to 0.75 mm because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Regarding claim 25, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 22.
Modified Leblanc fails to teach wherein the hydraulic radius of the second opening is 0.02 mm-0.2 mm.
Leblanc teaches wherein the port sizes (the hydraulic radius of the first and hydraulic radius second opening) are result-effective variables. Specifically, Leblanc teaches that the port size is customized based on the type of transport mechanism, e.g. various pipette tips or various size or tubing (para. 0111 and Fig. 5). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). In addition, Leblanc teaches the device is for analyzing different types of samples (molecules, cells, small molecules or particles), and thus different transport mechanisms may be use for the different inlet port in order to accord different sample type.
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the hydraulic radius the second opening of Leblanc such that the hydraulic radius of the second opening is 0.02 mm – 0.2 mm because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Regarding claim 26, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 15. Modified Leblanc further teaches wherein each of the at least two spacers is an adhesive layer (paras. 0015, 0049 and 0126, gasket is made from a silicone thermoplastic Genomier which has a contact adhesive).
Regarding claim 27, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 15. Leblanc further teaches wherein the first opening and the second opening are both on the first cover .
Claims 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Leblanc et al. (US 20120244043 A1) in view of Jaffe et al. (US 20160123886 A1).
Regarding claim 17, modified Leblanc teaches the sample analysis system according to claim 15.
Leblanc teaches a microfluidic device comprising a detection module (optical imaging unit), where molecules, cells, small molecules or particles are to be detected, identified, measured or interrogated on the basis of at least one predetermined characteristic such as fluorescent labels (para. 0150 and 0175). Leblanc further teaches that the detection module includes a microscope (para. 0150).
Leblanc does not disclose the structure of the microscope and thus fails to explicitly teach wherein the optical imaging unit comprises a first lens assembly and a second lens assembly; the first lens assembly is configured to image the first sample; the second lens assembly is configured to image the microdroplets; a focal length of the first lens assembly is smaller than a focal length of the second lens assembly, and a field of view of the first lens assembly is smaller than a field of view of the second lens assembly.
However, Jaffe teaches an integrated fluorescence scanning system for imaging cells and fluorophore, etc. (paras. 0003 and 006). Jaffe teaches that system includes a microscope (170) that comprises two different objective lenses (410, 412) in order to provide different magnifications.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microscope of the detection module taught by Leblanc with a microscope that includes two objective lenses of different magnifications as taught by Jaffe in order to provide different magnifications with a reasonable expectation of success (Jaffe, para. 0068) (MPEP 2143)(I)(G). In addition, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have one of the objective lenses to have a higher magnification to image samples with molecules and selected the other objective lens to have a lower magnification to image samples with droplets in order to image different types of samples that are accommodated by the device of Leblanc (Leblanc, para. 0153) with a reasonable expectation of success (MPEP 2143)(I)(G).
The teachings of modified Leblanc would yield the optical imaging unit (microscope) comprises a first lens assembly (the objective lens with a higher magnification) and a second lens assembly (the objective lens of lower magnification); the first lens assembly is configured to image the first sample (interpreted as an functional limitation. The first sample is not positive recited. With the above modification, the first lens assembly has a higher magnification and is tailored for molecules); the second lens assembly is configured to image the microdroplets (interpreted as an functional limitation. With the above modification, the second lens assembly has a lower magnification and is tailor for molecules); a focal length of the first lens assembly is smaller than a focal length of the second lens assembly, and a field of view of the first lens assembly is smaller than a field of view of the second lens assembly (first lens assembly has a higher magnification and thus a smaller focal length and a smaller field view than that of the second lens assembly).
Regarding claim 19, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 17. Modified Leblanc further teaches wherein a magnification of the first lens assembly is greater than a magnification of the second lens assembly (see claim 17 above).
Regarding claim 20, modified Leblanc teaches the sample analysis system according to claim 15.
Leblanc teaches a microfluidic device comprising a detection module (optical imaging unit), where molecules, cells, small molecules or particles are to be detected, identified, measured or interrogated on the basis of at least one predetermined characteristic such as fluorescent labels (para. 0150 and 0175). Leblanc further teaches that the detection module includes a microscope (para. 0150).
Leblanc does not disclose the structure of the microscope and thus fails to explicitly teach wherein the optical imaging unit comprises a third lens assembly and a compensation lens assembly.
However, Jaffe et al. (US 20160123886 A1) teaches an integrated fluorescence scanning system for imaging cells and fluorophore, etc. (paras. 0003 and 006). Jaffe teaches that system includes a microscope (170) that comprises two different objective lenses (410, 412) in order to provide different magnifications.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microscope of the detection module taught by Leblanc with a microscope that includes two objective lenses of different magnifications as taught by Jaffe in order to provide different magnifications with a reasonable expectation of success (Jaffe, para. 0068) (MPEP 2143)(I)(G).
The teachings of modified Leblanc would yield wherein the optical imaging unit comprises a third lens assembly (one of the two objective lenses) and a compensation lens assembly (the other objective lens)(“compensation” is interpreted as an intended use. The objective lens meets the structural limitation of the intended use).
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Leblanc et al. (US 20120244043 A1) in view of Jaffe et al. (US 20160123886 A1) as applied to claim 17, and further in view of Nakajima et al. (US 20190101742 A1).
Regarding claim 18, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 17.
Modified Leblanc fails to explicitly teach wherein the focal length of the first lens assembly is 1 mm to 2 mm, the field diameter of the first lens assembly is 1 mm to 2 mm; the focal length of the second lens assembly is 1 mm to 2 mm, the field of view of the second lens assembly is 5 mm to 10 mm.
However, Nakajima teaches the focal points of the imaging section are changed in accordance with, e.g., the size of the material component to be analyzed” (para. 0058), and thus teaches focal length as well as the field of view and field diameter which are affected by focal length are result-effective variable. Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the focal length and field diameter of the first lens assembly to be 1 mm to 2 mm and 1 mm to 2 mm, respectively; and to modify the focal length and field of view of the second lens assembly to be 1 mm to 2 mm and 5 to 10 mm, respectively, because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Claims 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over Leblanc et al. (US 20120244043 A1) in view of Stumbo et al. (US 20190002956 A1).
Regarding claim 28, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 15. (This claim uses the alternative interpretation that the first and second openings at the openings at the chip carrier top corresponds to the middle inlet and the left inlet, respectively)
Modified further teaches Leblanc teaches the second joint device (tubing and the corresponding plastic chip port) comprises a second joint portion (tubing), the second joint portion comprises a second joint (the opening of the tubing that is in the plastic chip port), the second joint is connected to the second opening (Fig. 9B)(a portion of the tubing is directly connected to the second opening, and thus the entire tubing is connected to second opening through that portion).
Leblanc teaches droplets are formed before the sample fluid is introduced to the microfluidic device (para. 0082). Modified Leblanc further teaches a device that generates droplets is connected to a tubing such that the droplets can be introduced into the microfluidic device (see claim 15). Modified does not teach the structure that transports the droplets from droplet generating device to the tubing and thus fails to teach wherein the second joint device comprises a second joint portion, the second joint portion comprises a first joint and a second joint, the second joint is connected to the second opening, the first joint is away from the second opening, a size of the first joint along a direction perpendicular to an extension direction of the flow path is smaller than a size of the second joint along the direction perpendicular to the extension direction of the flow path.
However, Stumbo teaches a fluid transporter for transporting droplets from a reservoir to a another location in a single file configuration. Stumbo teaches the fluid transporter includes a first joint (junction 106 to 74) and a second joint (outflow port 178), a size of the first joint along a direction perpendicular to an extension direction of the flow path of the droplet is smaller than a size of the second joint along the direction perpendicular to the extension direction of the flow path droplet (the diameter 74 is smaller than the diameter of 178).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubing of the Leblanc with the fluid transporter taught by Stumbo in order to transport droplets from the droplet generator to the microfluidic device in a single file with a reasonable expectation of success (Stumbo, abstract)(MPEP 2143)(I)(G).
The teachings of modified Leblanc would yield the second joint device (fluid transporter and the corresponding chip port) comprises a second joint portion (fluid transporter between junction 106 to 178), the second joint portion comprises a first joint (Fig. 6 of Stumbo, junction 106 to 74) and a second joint (Fig. 6 of Stumbo, outflow port 178), the second joint is connected to the second opening (after the modification, 212 of Stumbo is the tubing of Leblanc’s Fig. 9B, and outflow port 178 of Stumbo is the tubing opening is in the plastic chip port), the first joint is away from the second opening (Fig. 9B of Leblanc and Fig. 6 of Stumbo), a size of the first joint along a direction perpendicular to an extension direction of the flow path is smaller than a size of the second joint along the direction perpendicular to the extension direction of the flow path (Fig. 6 of Stumbo, the diameter of 74 is smaller than the diameter of 178).
Regarding claim 29, modified Leblanc teach The sample analysis system according to claim 28, wherein the second joint device (fluid transporter and the corresponding chip port) further comprises a second interface block (Stumbo Fig. 6, the portion of the fluidic transporter from 176 to 106 and a valve in the transporter as taught in para. 0038), the second interface block is connected to the first joint (junction 106 to 74) (Stumbo Fig. 6).
Leblanc teaches teach a plastic chip port is sleeved at the second joint (Fig. 9B), and thus fails to teach the second joint device comprises a second sealing member and the second sealing member is sleeved at the second joint (Fig. 9B).
However, Leblanc teaches the chip port forms a more reliable seal with a elastomer (para.0010).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plastic chip port in Fig. 9B taught by Leblanc to be made of elastomer in order to provide a more reliable seal with a reasonable expectation of success (Leblanc, para. 0010) (MPEP 2143)(I)(G).
The teachings of modified Leblanc would yield the second joint device comprises a second sealing member (chip port made of elastomer) and the second sealing member is sleeved at the second joint (Fig. 9B).
Regarding claim 30, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 29. Modified Leblanc further wherein the second interface block comprises a second liquid inlet channel (sample port 174, the port has a thickness thus it is interpreted as a channel), a second liquid outlet channel (the portion of 172 from 174 to 106), a second control valve group (para. 0038, transporter has a valve), and a second common channel (the portion of 172 from 180 to 174), and the second common channel is connected to the first joint (Fig. 6).
Regarding claim 31, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 30. wherein a hydraulic radius of each of the second liquid inlet channel (sample port 174) and the second common channel (the portion of 172 between 180 to 174) is greater than a hydraulic radius of the second liquid outlet channel (the portion of 172 between 180 to 174)(Figs. 6-7, the hydraulic radius of 172 where the droplets are in single file is smaller than radii of the other two channels).
Regarding claim 32, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 15. (This claim uses the alternative interpretation that the first and second openings at the openings at the chip carrier top corresponds to the middle inlet and the left inlet, respectively)
Modified fails to teach wherein the first joint device (pipette tip and the corresponding plastic chip port, Fig. 9B) comprises a first joint portion, a first interface block, and a first sealing member, an end of the first joint portion is connected to the first opening, and another end of the first joint portion is connected to the first interface block, the first sealing member is sleeved on the first joint portion.
However, Leblanc teaches the device is configured to detect a variety types of samples (para. 0096) and allow multiple samples to interact/coalescent (para. 0096). In addition, Leblanc further teaches the device is configured to accommodate different transport mechanism to introduce samples (para. 0124).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the middle inlet and pipette tip with an inlet (like the left inlet) that fit a tubing and a tubing to have another inlet for introducing droplets in order that two different droplet samples can interact or coalescent with a reasonable expectation of success (para. 0096) (MPEP 2143)(I)(G).
In addition, Leblanc teaches the chip port forms a reliable seal with a elastomer (para. 0010).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plastic chip port in Fig. 9B taught by Leblanc to be made with elastomer in order to provide a more reliable seal with a reasonable expectation of success (Leblanc, para. 0010) (MPEP 2143)(I)(G).
The teachings of modified Leblanc yields the first joint device (tubing and corresponding chip port) comprises a first joint portion (tubing) and a sealing member (chip port made with elastomer), an end of the first joint portion is connected to the first opening (similar to the second opening and the corresponding tubing show in Fig. 9B, a portion of the tubing is directly connected to the first opening, and thus the entire tubing is connected to first opening through that portion) and the first sealing member is sleeved on the first joint portion (tubing is in the elastomer chip port)(Fig. 9B).
Leblanc further teaches droplets are formed before the sample fluid is introduced to the microfluidic device (para. 0082). Modified Leblanc further teaches a device that generates droplets is connected to a tubing such that the droplets can be introduced into the microfluidic device (see claim 15).
Modified Leblanc fails to teach wherein the first joint device comprises a first interface block, and another end of the first joint portion is connected to the first interface block.
However, Stumbo teaches a fluid transporter for transporting droplets from a reservoir to a another location in a single file configuration. Stumbo teaches the fluid transporter comprises a first joint portion (Stumbo Fig. 6, the portion of the fluid transport from 106 to 178), a first interface block (Stumbo Fig. 6, the part of the transporter from 176 to 106 and a valve in the transporter as taught in para. 0038), and an end of the first joint portion is connected to the first interface block (Stumbo Fig. 6).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubing of the Leblanc to with the fluid transporter taught by Stumbo in order to transport droplets from the droplet generator to the microfluidic device in a single file with a reasonable expectation of success (Stumbo, abstract)(MPEP 2143)(I)(G).
The teachings of modified Leblanc would yield wherein the first joint device (fluid transporter taught by Stumbo and the corresponding chip port) comprises a first joint portion (Fig. 6 of Stumbo, junction 106 to 178), a first interface block (Stumbo Fig. 6, the part of the transporter from 176 to 106 and a valve in the transporter as taught in para. 0038), and a first sealing member (chip port made with elastomer), an end of the first joint portion is connected to the first opening (similar to the second opening and the corresponding tubing show in Fig. 9B, a portion of the tubing is directly connected to the first opening, and thus the entire tubing is connected to second opening through that portion), and another end of the first joint portion is connected to the first interface block (Fig. 6 of Stumbo, junction 106 to 74) (Stumbo Fig. 6), the first sealing member is sleeved on the first joint portion (178 is in the elastomer chip port in modified Leblanc)(Fig. 9B).
Regarding claim 33, modified Leblanc teaches all of the elements of the current invention as stated above with respect to claim 32. Modified Leblanc further wherein the first interface block comprises a first liquid inlet channel (172), a first liquid outlet channel (128a), a first control valve group (a valve in the transporter as taught in para. 0038 of Stumbo), and a first common channel (128b), and the first common channel is connected to the first joint portion (junction 106 to 178)(Fig. 6 of Stumbo).
Conclusion
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/M.L.C./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758