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 .
Priority
Receipt is acknowledged of certified copies of papers (CN2021107430689 – Filed 06/30/2021) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 02/05/2024 has been certified and made of record.
Claim Objections
Claim 24 is objected to because of the following informalities:
The claim dependency of “according to claim 16” is drawn to a canceled claim. Appropriate correction is required.
For examination purposes, claim 24 will be examined on the merits of claim 18, which is assumed to be the intended dependency.
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:
Sample receiving module in claim 18 – The specification teaches the sample receiving module comprises a sample loading chamber, which is a piston-style container (para. [0020]).
Sample lysis and nucleic acid extraction module in claim 18 – The specification teaches the sample lysis and nucleic acid extraction module comprises a first mixing chamber and a second mixing chamber, each of said first mixing chamber and said second mixing chamber being a piston-style container comprising a chamber and a piston disposed within the chamber (para [0019]).
Nucleic acid amplification module in claim 18 – The specification teaches the amplification module as having one or more multiple amplification region units – specifically including a plurality of amplification reaction chambers (para. [0029]).
Inert Liquid Module in claim 28 -The specification teaches the inert liquid module as an oil filing chamber (para. [0034]).
Preamplification Zone Unit in claim 29.
Signal detection module in claim 35.
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.
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 29-30, 35-37 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 claims 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. Specifically, the disclosure fails to provide sufficient structure regarding what comprises a preamplification zone unit (Claim 29) in the device. Claim 30 is included in this rejection since the claim depends on claim 29. The disclosure also fails to provide sufficient structure for the signal detection module. Although the function of detecting nucleic acid amplification products is provided in the specification (para. [0135]), the structure for providing said signal detection is unknown (Claim 35). Claims 36 and 37 are included in this rejection since they depend on claim 35.
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.
Claim limitation “signal detection module” and “preamplification zone unit” invokes 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 specification fails to disclose sufficient structure for the signal detection module to perform the function of detecting nucleic acid amplification products (Claim 35). Furthermore, the specification fails to provide the structure of the preamplification zone module, which carries out the function for carrying out a first round of amplification of nucleic acid molecules (Claim 29). Therefore, claims 29 and 35 are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Dependent claims 30, 36, and 37 are included in this rejection since they depend on the indefinite rejected claims.
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.
For examination purposes, if an element achieves the function of detecting nucleic acid amplification products, this will then be seen as meeting the claim limitation. Furthermore, if a claim element achieves the function of carrying out a first round of amplification of nucleic acid molecules, this will be seen as meeting this claim limitation.
Additionally, claims 26, 27, 29, and 30 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.
Claims 26, 27, and 29 recites the limitation "multiple amplification zone unit.” There is insufficient antecedent basis for this limitation in the claim. Claim 30 is included in this rejection, as it depends on rejected claim 29. Claim 30 is included in the rejection as it depends on rejected claim 29.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 18-23, 25, 29-37 are rejected under 35 U.S.C. 103 as being unpatentable over Barten et al. (US 20060222569 A1) (already referenced in the IDS).
Regarding Claim 18, Barten et al. teaches a chip device (See annotated FIG. 5 below) for detecting nucleic acids in a sample (para. [0060]), wherein said chip device has a substrate (FIG. 5) and piston-style containers (FIG. 5), said piston-style containers being in communication with each other through a microfluidic channel (channels 6, 8, 10, 17, 24, 25),
Wherein each piston style container comprises a chamber and a piston disposed within the chamber, the chamber having an opening in communication with said microfluidic channel at the bottom thereof (FIG. 5), and
said chip device further has a piston valve disposed between the containers for controlling fluidic communication between interconnected containers (“Then the flow of the sample or of any liquid passed between the first (2) and the second chambers (3) during the preparation of the analyte through the second connector (9) can be prevented without the provision of a means of controlling the flow, e.g. a valve, by restricting the movement of liquid in the additional devices connected via the connector (9) to the device of the present invention or by restricting the movement of the means of flow regulation, e.g. a piston in the additional chamber, e.g. by locking the plunger of the syringe attached to the connector (9).” (para. [0022]). Furthermore, although Barten et al. does not explicitly teach a piston valve, Barten et al. teaches that “"means of flow regulation" as used herein refers to any device that allows to restrict the flow between two chambers, within a channel or between the exterior of the device and the interior in either one direction or both directions. Examples include without limitation valves of various forms known to the skilled practitioner, including ball valves, membrane valves, and the like, septums and stop cocks.” (para. [0012]). Barten et al. teaches that “preferably a further valve (32) is provided between channels (6, 8, 10) and channels (24, 25) to separate the reaction/mixing chambers (2, 3) from the reagent storage chambers (20, 21 not shown here).” (para. [0122]).
Furthermore, regarding the limitation “the valve piston being configured to move to the bottom of the chamber for covering said openings, blocking communication of the chamber with the microfluidic channel, thereby blocking fluidic communication between containers connected through said microfluidic channel”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate from the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II).
Therefore, the valve employed by Barten et al. would be fully capable of achieving every intended use because Barten et al. teaches “then the flow of the sample or of any liquid passed between the first (2) and the second chambers (3) during the preparation of the analyte through the second connector (9) can be prevented without the provision of a means of controlling the flow, e.g. a valve, by restricting the movement of liquid in the additional devices connected via the connector (9) to the device of the present invention or by restricting the movement of the means of flow regulation, e.g. a piston in the additional chamber, e.g. by locking the plunger of the syringe attached to the connector (9).” (para. [0022]), and the valve would be structurally capable of being configured to move to the bottom of the chamber for covering said openings, blocking communication of the chamber with the microfluidic channel, thereby blocking fluidic communication between containers connected through said microfluidic channel.
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Barten et al. teaches that chip device (FIG. 5) comprises a sample receiving module through injection syringe (FIG. 5, element 19) containing the sample solution (P) (para. [0124]); sample lysis and nucleic acid extraction module through chambers (FIG 5, elements 2, 3, 20, 21) – which contain reactants L (Lysis Buffer), W (Wash buffer), E (elution solution), as such solutions are used for sample lysis reaction, and a nucleic acid amplification module via element 40, which is a PCR chamber which is used for PCR amplification (“Such thermic decoupling can be provided, for example, by a cut out section (35) for PCR amplification (para. [0123]). (Note: these claim elements were invoked via 112(f)).
Barten et al. fails to teach:
The nucleic acid amplification module comprises a plurality of reaction chambers for carrying out the amplification reaction
Regarding limitation I, it has been established that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP § 2144.04 VI). Although Barten et al. teaches only one PCR amplification chamber, it would be obvious to one of ordinary skill in the art to duplicate the amplification chamber through using a plurality of reaction chambers, specifically to achieve multiple amplification reactions. Therefore, the claim limitation is prima facie obvious.
Regarding claim 19, modified Barten et al. teaches the chip device according to claim 18. Barten et al. further teaches a sample receiving module through a piston style container comprising a chamber and piston disposed in the chamber (FIG. 5, element 19).
Regarding claim 20, modified Barten et al. teaches the chip device according to claim 18. Barten et al. further teaches a sample lysis and nucleic acid extraction module through piston style containers comprising a chamber and a piston disposed within the chamber (sample lysis and nucleic acid extraction module through chambers (FIG 5, elements 2 and 3), which structurally act as mixing chambers (para. [0116]). Barten et al. teaches that “preferably a further valve (32) is provided between channels (6, 8, 10) and channels (24, 25) to separate the reaction/mixing chambers (2, 3) from the reagent storage chambers (20, 21 not shown here).” (para. [0122]), which anticipates a mixing chamber valve is arranged between said first mixing chamber and said second mixing chamber. Barten et al. also teaches a loading valve arranged between said first mixing chamber and an upstream sample-receiving module through unidirectional restriction valve (element 31) present in their chip device (para. [0121]).
Regarding claim 21, modified Barten et al. teaches the chip device according to claim 18, wherein said sample lysis module of said sample lysis and nucleic extraction module comprises a lysis reagent storage chamber for holding the lysis reagent (L), which is a piston-style container (FIG 5, element 3). Barten et al. teaches that “preferably a further valve (32) is provided between channels (6, 8, 10) to separate the reaction/mixing chambers (2, 3) from the reagent storage chambers (20, 21 not shown here).” (para. [0122]), which anticipates a lysis reagent valve arranged between the storage chamber and chamber for sample lysis.
Regarding claim 22, modified Barten et al. teaches the chip device according to claim 21. Barten et al. further teaches that the chip device contains W (Wash buffer), E (elution solution) in the piston style containers (FIG 5, element 20, 21). The piston style containers are also connected to a chamber in which eluting and cleaning are performed in the device, specifically by moving the sample solution back and forth between chambers (element 2 and 3) (para. [0124]).
Regarding claim 23, modified Barten et al. teaches the chip device according to claim 18. Barten et al. teaches a sample to be amplified chamber, which is a piston style container comprising a chamber and a piston in the chamber for holding sample of the lysed and extracted nucleic acid solution through piston style container (element 2), where the sample and lysis solution mix prior to PCR amplification and detection (FIG. 5 and 6).
Regarding claim 25, modified Barten et al. teaches the chip device according to claim 18. The structure resulting in modified structure of claim 18 would encompass a structure comprising a plurality of amplification reaction chambers for carrying out a nucleic acid amplification reaction. Furthermore, a microfluidic channel delivers the sample solution into the amplification reaction chamber.
Regarding claim 29, modified Barten et al. teaches the chip device according to claim 18. The structure resulting in modified structure of claim 18 would encompass a structure comprising a preamplification unit disposed upstream of said multiple amplification zone unit for carrying out a first round of amplification of nucleic acid molecules.
Regarding claim 30, modified Barten et al. teaches the chip device according to claim 29. The structure resulting in modified structure of claim 29 would encompass a structure comprising a nested amplification chamber, and therefore, the claim is prima facie obvious.
Regarding claim 31, modified Barten et al. teaches the chip device according to claim 18. Barten et al. further teaches a piston movement control member provided above the valve piston for controlling upward and downward movements of the valve piston within the chamber (See annotated FIG. 5).
Regarding claim 32, modified Barten et al. teaches the chip device according to claim 31. Barten et al. further teaches that a screw thread or a snap in device can be provided to the exterior facing side of the piston, as this allows attachment of the piston rod to the piston itself (para. [0036]). This aligns with claim limitation of a piston valve having an internal thread, and piston motion control member having an external thread – specifically for providing attachment.
Regarding claim 33, modified Barten et al. teaches the chip device according to claim 18. Barten et al. further teaches that elasticity in the piston chambers (element 2 and 3) is preferred, as this arrangement coupled with nonelastic pistons prevents the undesired inflow and outflow of liquid into the further chambers or the second chamber (3) and the further chambers when liquid is moved between the first (2) and/or the second chamber (3), which might otherwise occur (para. [0035]).
Regarding claim 34, Barten et al. teaches the chip device according to claim 18. Barten et al. further teaches a flow channel in communication with the openings at the bottom of the piston valve chamber from a piston under the piston valve chamber via an upward channel (elements 6, 8, 24, 25).
Regarding claim 35, Barten et al. teaches an instrument (See annotated FIG. 5 below) for detecting nucleic acids in a sample (para. [0060]), wherein said chip device has a substrate (FIG. 5) and piston-style containers (FIG. 5), said piston-style containers being in communication with each other through a microfluidic channel (channels 6, 8, 10, 17, 24, 25),
Wherein each piston style container comprises a chamber and a piston disposed within the chamber, the chamber having an opening in communication with said microfluidic channel at the bottom thereof (FIG. 5), and
said chip device further has a piston valve disposed between the containers for controlling fluidic communication between interconnected containers (“Then the flow of the sample or of any liquid passed between the first (2) and the second chambers (3) during the preparation of the analyte through the second connector (9) can be prevented without the provision of a means of controlling the flow, e.g. a valve, by restricting the movement of liquid in the additional devices connected via the connector (9) to the device of the present invention or by restricting the movement of the means of flow regulation, e.g. a piston in the additional chamber, e.g. by locking the plunger of the syringe attached to the connector (9).” (para. [0022]). Furthermore, although Barten et al. does not explicitly teach a piston valve, Barten et al. teaches that “"means of flow regulation" as used herein refers to any device that allows to restrict the flow between two chambers, within a channel or between the exterior of the device and the interior in either one direction or both directions. Examples include without limitation valves of various forms known to the skilled practitioner, including ball valves, membrane valves, and the like, septums and stop cocks.” (para. [0012]). Barten et al. teaches that “preferably a further valve (32) is provided between channels (6, 8, 10) and channels (24, 25) to separate the reaction/mixing chambers (2, 3) from the reagent storage chambers (20, 21 not shown here).” (para. [0122]).
Furthermore, regarding the limitation “the valve piston being configured to move to the bottom of the chamber for covering said openings, blocking communication of the chamber with the microfluidic channel, thereby blocking fluidic communication between containers connected through said microfluidic channel”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate from the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II).
Therefore, the valve employed by Barten et al. would be fully capable of achieving every intended use because Barten et al. teaches “then the flow of the sample or of any liquid passed between the first (2) and the second chambers (3) during the preparation of the analyte through the second connector (9) can be prevented without the provision of a means of controlling the flow, e.g. a valve, by restricting the movement of liquid in the additional devices connected via the connector (9) to the device of the present invention or by restricting the movement of the means of flow regulation, e.g. a piston in the additional chamber, e.g. by locking the plunger of the syringe attached to the connector (9).” (para. [0022]), and the valve would be structurally capable of being configured to move to the bottom of the chamber for covering said openings, blocking communication of the chamber with the microfluidic channel, thereby blocking fluidic communication between containers connected through said microfluidic channel.
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Barten et al. teaches that chip device (FIG. 5) comprises a sample receiving module through injection syringe (FIG. 5, element 19) containing the sample solution (P) (para. [0124]); sample lysis and nucleic acid extraction module through chambers (FIG 5, elements 2, 3, 20, 21) – which contain reactants L (Lysis Buffer), W (Wash buffer), E (elution solution), as such solutions are used for sample lysis reaction, and a nucleic acid amplification module via element 40, which is a PCR chamber which is used for PCR amplification (“Such thermic decoupling can be provided, for example, by a cut out section (35) for PCR amplification (para. [0123]). (Note: these claim elements were invoked via 112(f)).
Barten et al. teaches a signal detection module for detecting nucleic acid amplification products through detection chamber (element 41). “The detection chamber (41) comprises in a preferred embodiment pin-electrodes (42) protruding into the chamber to which analyte binding substances are attached. The binding of the analyte to the analyte binding substances will then be detected electrochemically” (para. [0123]).
Barten et al. fails to teach:
The nucleic acid amplification module comprises a plurality of reaction chambers for carrying out the amplification reaction
Regarding limitation I, it has been established that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP § 2144.04 VI). Although Barten et al. teaches only one PCR amplification chamber, it would be obvious to one of ordinary skill in the art to duplicate the amplification chamber through using a plurality of reaction chambers, specifically to achieve multiple amplification reactions. Therefore, the claim limitation is prima facie obvious.
Regarding Claim 36, Barten et al. teaches the instrument according to claim 35. Furthermore, Barten et al. teaches a piston valve, where the flow channel is in communication with the openings at the bottom of the piston valve chamber from a position under the valve chamber via an upward channel (FIG. 5, element 6, 8, 24).
Regarding Claim 37, Barten et al. teaches the instrument according to claim 35. Barten et al. further teaches that the invention relates to a device, kit, and method for contamination-free preparation of analyte for biopolymer comprising liquids (abstract). Biopolymers often exist in samples obtained from a patient, such as blood samples (para. [0001]). Thus, Barten et al.’s invention structurally acts as a point-of-care testing instrument.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Barten et al. (already referenced) in view of Kaigala et al. (US 20200061616 A1) (referenced in 892).
Regarding claim 24, modified Barten et al. teaches the chip device according to claim 18, but fails to teach that the nucleic acid extraction module further comprises a dilution chamber. Kaigala et al. teaches a microfluidic device featuring dilution chamber (element 21) in device (element 1). Kaigala et al. teaches that extracted analytes can be brought to the dilution chamber (element 21) in order to perform a controlled dilution of the analyte (para. [0066]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Kaigala et al.’s teaching of a dilution chamber in Barten et al.’s chip device because dilution chamber allow controlled dilutions of an analyte to be performed in the microfluidic device. This method of improving modified Barten et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Kaigala et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Barten et al. and Kaigala et al. to obtain the invention specified in claim 24.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Barten et al. (already referenced) in view of Ying et al. (US 20170029871 A1) (referenced in 892).
Regarding claim 26, modified Barten et al. teaches the chip device according to claim 25. Barten et al. further teaches piston valves and valve chambers present in chip device. Modified Barten et al. fails to teach that the amplification reaction chambers are arranged in a circumferential direction. Ying et al. teaches a microfluidic device with a circular cross-sectional fluidic channel shape. Common fluidic channel (106) connects the plurality of wells (104) in a circular shape (FIG. 1), as Ying et al. teaches that this circular shape is chosen so as not to impede liquid flow (para. [0043]). This circular shape is structurally equivalent to the circumferential chamber configuration described in claim limitation of claim 26.
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Ying et al. teaching of circumferential chambers in Barten et al.’s chip device because the circular channel structure does not impede liquid flow for the plurality of wells. This method of improving modified Barten et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ying et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Barten et al. and Ying et al. to obtain the invention specified in claim 26.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Barten et al. (already referenced) in view of Takagi (US 20110065591 A1) (referenced in 892).
Regarding claim 27, modified Barten et al. teaches the chip device according to claim 25, but fails to teach that the plurality of amplification reaction chambers are arranged in an array, with each reaction chamber being connected to a main flow channel via a branch flow channel. Takagi teaches a biochip for quantitative analysis for target DNA (abstract), where PCR amplification can be performed in microchamber array (element 10) (para. [0042]). Takagi teaches that chambers (104) can be used to measured fluorescence intensity for each chamber to form a regression curve (for estimation of the amount of DNA in a sample) (para. [0042]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Takagi’s teaching of an amplification array in Barten et al.’s chip device because the microchamber arrays enable a regression curve to be created for estimation of the amount of DNA in a sample. This method of improving modified Barten et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Takagi. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Barten et al. and Takagi to obtain the invention specified in claim 27.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Barten et al. (already referenced) in view of Cumbie (US 20240218434 A1) (referenced in 892).
Regarding claim 28, modified Barten et al. teaches the chip device according to claim 18, which features valves, but fails to teach an inert liquid module with an oil filling chamber and filling valve. Cumbie teaches a microfluidic chip (FIG. 3) using a PCR system comprising thermocycling chambers (102) (para. [0065]). Cumbie further teaches that a portion of oil is provided into the thermocycling chamber, as the oil prevents evaporation of any liquid from the liquid volume during amplification if the thermocycling chamber is an open well as described previously (para. [0101]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Cumbie’s teaching of oil provided in a chamber in Barten et al.’s chip device because placing oil in the chamber prevents evaporation of any liquid from the liquid volume during amplification. This method of improving modified Barten et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Cumbie. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Barten et al. and Cumbie to obtain the invention specified in claim 28.
Conclusion
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/J.F.Y./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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