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
Claims 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected device and kit, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 FEBRUARY 2026.
Applicant’s election without traverse of Group I: Claims 1-31 in the reply filed on 18 FEBRUARY 2026 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 24 MAY 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 24 MAY 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 42, character 3311. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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: There is a period missing at the end of the paragraph, page 36 line 27.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: in element (ii) it should read “(ii) a measurement apparatus”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: in the instance of ‘incorporates optical measurement apparatus’ should be ‘incorporates the optical measurement apparatus’. 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:
A ‘microfluidic manifold for supplying reagents’ in claim 1.
A manifold does not connote any particular structure. The microfluidic manifold comprises a cartridge socket, a pressure manifold and a chip manifold, as described later in Claim 1.
A ‘pressure manifold …for selectively connecting the pressure’ and ‘pressure manifold for supplying pressure to the cartridge’ in claim 1, 2, 4.
A manifold does not connote any particular structure. The manifold is described as a plurality of pressure feed lines connectable to an external pressure source or originating from a shared pressure input connector.
A ‘reagent manifold …for selectively connecting upstream to….’ in claim 4.
A manifold does not connote any particular structure. The manifold is described as a plurality of reagent output lines, as described in claim 4 and claim 5.
A ‘cartridge securing element…for fixing the cartridge in position and ensuring…’ in claim 11.
An element does not connate any particular structure. The element is described as a quick release mechanism in claim 12.
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 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 2-31 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.
In each of the preamble of the claims, it recites ‘A measurement device according to claim…’. For proper refence back to a dependent claim (antecedent basis), it should read ‘The measurement device according to claim …’ as it is referring to the device a previously claimed and it is further defining the invention. A new measurement device is not being claimed in each of dependent claims.
Claim 12 is 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.
Regarding claim 12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 23, 26 and 31 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.
In the instant claim there are portions that are offset by parentheses including an optionally phrase , the connected to the cartridge phrase and open/close. It is unclear to the Examiner if this portion offset is actually supposed to include in the claim language and the further limit the invention. In addition, it unclear if the ‘optionally’ phrase means that the claim requires this limitation.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 9-29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US Patent 9,410,977 B2 to ILLUMINA, submitted on the Information Disclosure Statement on 24 MAY 2023, US Patent Documents.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the ILLUMINA reference discloses a measurement device, Figure 1A, 1B, 2 and 3, comprising: (I) an analysis chip mount, for receiving an analysis chip, Figure 9, flow cell 2020, Column 8 line 64-67; (ii) measurement apparatus, for analyzing an analysis chip mounted on the analysis chip mount, Column 7 line 58 – Column 8 line 39, detection apparatus; and (iii) a master microfluidic module, for supplying reagents to an analysis chip mounted on the analysis chip mount, the master microfluidic module, Figure 1A, fluidic system 100, Column 4 line 1-12, comprising: a cartridge socket, having a plurality of cartridge socket inlet ports and cartridge socket outlet ports, for receiving a reagent cartridge, Figure 1A-3, entire Column 4 to Column 5 line 7, sippers 103 and 104 have open tip and port 106; a pressure manifold, comprising a plurality of pressure feed lines connectable to an external pressure source, each pressure feed line having an associated multi-way valve assembly for selectively connecting the pressure feed line to either an external pressure output line or a cartridge socket pressure line, Figure 9, Column 8 line 64-Column 9 line 47; and a chip input manifold, Figure 1A, 1B, manifold assembly 101, comprising a plurality of chip input lines for providing reagent to said analysis chip in use, Figure 1A, 1B, ports 110/112; each chip input line having an associated multi-way valve assembly for selectively connecting the chip input line to either a cartridge socket reagent line or an external reagent input line, Figure 1A, 1B, valves 102/109; wherein the plurality of external pressure output lines terminate in a shared pressure output connector and the plurality of external reagent input lines originate from a shared external reagent input connector, Figure 9.
Regarding Claim 9, the ILLUMINA reference disclose the claimed invention wherein the measurement device according to claim l, wherein the multi-way valve assembly associated with each chip input line comprises two 2- way valves: with the chip input line split so as to be connected to the outlets of (i) a first 2-way valve with an inlet connected to the external reagent input line and (ii) a second 2-way valve with an inlet connected to the cartridge socket reagent line, Figure 1A, 1B, valves 102/109.
Regarding Claim 10, the ILLIMINA reference discloses the measurement device according to claim 1, wherein the multi-way valve assembly associated with each pressure feed line of the measurement device comprises two 2-way valves: with the pressure feed line split so as to be connected to the inlets of (i) a first 2-way valve with an outlet connected to the external pressure output line, and (ii) a second 2-way valve with an outlet connected to the cartridge socket pressure line, Figure 9, at valves Valve A/B.
Regarding Claim 11, the ILLIMINA reference discloses the measurement device according to claim 1, wherein the cartridge socket of the master microfluidic module and/or an attached secondary microfluidic module incorporates a cartridge securing element, for fixing the cartridge in position and ensuring a sealing connection between the cartridges and the cartridge socket, Figure 1A, 2, alignment pins Claim 20, Column 2 line 14-16.
Regarding Claim 12, the ILLUMINA reference discloses the measurement device according to claim 11, wherein the cartridge securing element is a quick release mechanism, such as a snap fit mechanism, Figure 1A, 2, alignment pins Claim 20, Column 2 line 14-16.
Regarding Claim 13, the ILLUMINA reference discloses the measurement device according to claim 11, wherein the cartridge socket incorporates one or more socket guides to correctly position a cartridge relative to the cartridge socket inlet ports and cartridge socket outlet ports, Figure 1A, 2, alignment pins Claim 20, Column 2 line 14-16, Column 4 line 58-Column 5 line 1.
Regarding Claim 14, the ILLUMINA reference discloses the measurement device according to claim 1, wherein the cartridge socket of the master microfluidic module and/or an attached secondary microfluidic module includes an electrical contact for providing power to the cartridge and allowing exchange of electrical signals with a cartridge inserted into the cartridge socket, Column 5 line 45-50, the components including pumps, valves, sensors and gauges are all electrically operated, inherently including a power source.
Regarding Claim 15, the reference ILLUMINA discloses the measurement device according to claim l, wherein the cartridge socket of the master microfluidic module and/or an attached secondary microfluidic module includes a motor, for moving components of the cartridge, Column 5 line 45-50, the components including pumps, a syringe pump requires a motor to work/function.
Regarding Claim 16, the reference ILLUMINA discloses the measurement device according to claim l, comprising an enclosure housing the analysis chip mount, the measurement apparatus, and the master microfluidic module, Column 14 line 44-45.
Regarding Claim 17, the reference ILLUMINA discloses the measurement device according to claim 16, wherein the pressure output connector and external reagent input connector of the master microfluidic module are positioned on the outside of the enclosure, Figure 9.
Regarding Claim 18, the reference ILLUMINA discloses the measurement device according to claim 16, wherein the enclosure incorporates a hatch for accessing the cartridge socket, Column 2 line 6-16, Column 10 line 14-26, interface slots.
Regarding Claim 19 , the reference ILLUMINA disclose the measurement device according to claim 18, wherein the shared pressure output connector and the external reagent input connector attach to a terminal block provided beneath the hatch, Column 2 line 6-16, Column 10 line 14-26, interface slots., Figure 8.
Regarding Claim 20, the reference ILLUMINA discloses the measurement device according to claim l, wherein the measurement device is an optical measurement device, and the measurement apparatus incorporates optical measurement apparatus, Column 8 line 58-Column 9 line 63.
Regarding Claim 21, the reference ILLUMINA discloses the measurement device according to claim 20, wherein the measurement device is an optical microscope and the measurement apparatus incorporates a light source and a light detector, Column 8 line 58-Column 9 line 63, microfluormeter.
Regarding Claim 22, the reference ILLUMINA discloses the measurement device according to claim 1, further comprising a reagent cartridge plugged into the cartridge socket of the master microfluidic module, Figure 8.
Regarding Claim 23, reference ILLUMINA discloses the measurement device according to claim 22, wherein the reagent cartridge comprises a housing having a mating surface contacting the cartridge socket of the master microfluidic module, Figure 1A, 8, the housing containing:- a plurality of reagent reservoirs (optionally provided as part of a detachable reagent tray/module as described above), Figure 6; - a plurality of cartridge pressurisation ports (connected to the cartridge socket inlet ports when installed on a microfluidic module) in fluid communication with the reagent reservoirs, Figure 1A, B, for pressurising the reagent reservoirs in use, Examiner’s Note: The language ‘for pressuring … in use’ is directed towards language for its intended use and does not further define the device structurally. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990); - a plurality of cartridge outlet ports (connected to the cartridge socket outlet ports when installed on a microfluidic module), Figure 1A, B, 3, Column 7 line 30, for dispensing reagent from the cartridge in use, also Examiner’s Note: The language ‘for dispensing … in use’ is directed towards language for its intended use and does not further define the device structurally. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990); ; and - a valve assembly, for regulating flow of reagents from the reagent reservoirs to the cartridge outlet ports in use, Figure 1B, 9, Column 7 line 26-Column 8 line 39, the valve assembly comprising: o a stator chip assembly, having a plurality of reagent channels each providing a flowpath from the reagent reservoirs to the cartridge outlet ports, each reagent channel having an associated valve section in which the reagent channel is capped with a flexible membrane; o a valve actuator, comprising a plurality of pins which are movable to actuate the valve sections between an open position in which the reagent channel is open and a closed position in which the flexible membrane is deformed so as to occlude the reagent channel; and o a rotor chip, rotatable relative to the valve actuator between a first position and a second position, wherein the rotor chip includes an actuator surface which pushes the pins to actuate the valve sections, and wherein said rotation causes the actuator surface to actuate (open/close) a different subset of the valve sections in the first position compared to the second position., Figure 1A-2, Column 4 line 1-Column 5 line 7, Column 7 line 26-Column 8 line 39.
Regarding Claim 24, the reference ILLUMINA discloses the measurement device according to claim 23, wherein the valve actuator comprises a plurality of cantilever-mounted pins attached to a support body, Figure 8, Column 10 line 14-26.
Regarding Claim 25, the reference ILLUMINA disclose the measurement device according to claim 24, wherein each cantilever-mounted pin is bendable from a resting state in which the pin deforms the flexible membrane to close its associated valve section to an engaged state in which the pin is bent away from the flexible membrane so as to open the valve section, Figure 8, Column 10 line 14-26.
Regarding Claim 26, the reference ILLLUMINA discloses the measurement device according to claim 22, wherein the reagent cartridge comprises a housing containing:- a plurality of reagent reservoirs (optionally provided as part of a detachable reagent tray/module as described above); - a plurality of cartridge pressurisation ports (connected to the cartridge socket inlet ports when installed on a microfluidic module) in fluid communication with the reagent reservoirs, for pressurising the reagent reservoirs in use; - a plurality of cartridge outlet ports (connected to the cartridge socket outlet ports when installed on a microfluidic module), for dispensing reagent from the cartridge in use; and - a valve assembly, for regulating flow of reagents from the reagent reservoirs to the cartridge outlet ports in use, the valve assembly comprising: o a stator chip assembly, having a plurality of reagent channels each providing a flowpath from the reagent reservoirs to the cartridge outlet ports, the plurality of reagent channels intersecting a circular groove, each reagent channel having an associated valve section provided at the circular groove in which the reagent channel is capped with a flexible membrane, the valve section being switchable between an open position in which the reagent channel is open and a closed position in which the flexible membrane is deformed so as to occlude the reagent channel; o a rotor chip, rotatable relative to the stator chip assembly between a first position and a second position, the rotor chip having a protrusion (e.g. in the form of bump or ridge, such as a notched ridge, as described above) which contacts and deforms the flexible membrane so as to close at least one of the valve sections, the protrusion being sited within the circular groove of the stator chip assembly wherein said rotation causes the protrusion to close a different subset of the reagent channels in the first position compared to the second position.
Regarding Claim 27, the reference ILLUMINA discloses the measurement device according to claim 23, wherein the reagent reservoirs are provided as part of a detachable reagent tray, Figure 6, Column 9 line 48-Column 10 line 13.
Regarding Claim 28, the reference ILLUMINA discloses the measurement device according to claim 23, wherein the rotor chip is a disc, and the actuator surface corresponds to a protrusion on said disc, Figure 5, Column 6 line 9-29.
Regarding Claim 29, the reference ILLUMINA discloses the measurement device according to claim 23, wherein the cartridge pressurisation ports and cartridge outlet ports are provided on a mating surface of the housing, Figure 1A, 8, Column 10 line 14-26.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-8 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 9,410,977 B2 to ILLUMINA, submitted on the Information Disclosure Statement on 24 MAY 2023, US Patent Documents.
Regarding Claim 2, the ILLUMINA reference discloses the measurement device, but is silent in regard to a secondary microfluidic module connected to the master microfluidic module via said shared pressure output connector and said shared external reagent input connector. It in interpreted by the Examiner that ‘incorporating’ is ‘further comprising’.
Even though the reference teaches one microfluidic module, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the number of modules to increase the number of samples to be measured simultaneously creating a higher throughput of the device and as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding Claim 3, the ILLUMINA reference suggest the measurement device according to claim 2, but is silent in regards to wherein the secondary microfluidic module comprises: a cartridge socket, having a plurality of cartridge socket inlet ports and cartridge socket outlet ports, for receiving a reagent cartridge; a pressure manifold for supplying pressure to the cartridge socket, comprising a plurality of pressure feed lines originating from a shared pressure input connector, each pressure feed line fluidly connected to a cartridge socket inlet port; and a reagent manifold, comprising a plurality of reagent output lines terminating in a shared reagent output connector, each reagent output line fluidly connected with a cartridge socket outlet port; wherein the pressure input connector is fluidly connected to the external pressure output connector of the master microfluidic module, and the reagent output connector is fluidly connected to the external reagent input connector of the master microfluidic module.
As mentioned above even though the reference teaches one microfluidic module, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the number of modules and its parts including the cartridge socket, pressure manifold and reagent manifold to increase the number of samples to be measured simultaneously creating a higher throughput of the device and as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding Claim 4, the ILLUMINA reference suggest the measurement device according to claim 2, but is silent in regards to wherein the secondary microfluidic module comprises: a cartridge socket, having a plurality of cartridge socket inlet ports and cartridge socket outlet ports, for receiving a reagent cartridge; a pressure manifold, comprising a plurality of pressure feed lines each having an associated multi-way valve assembly for selectively connecting the pressure feed line to either an external pressure output line or a cartridge socket pressure line; and a reagent manifold, comprising a plurality of reagent output lines having an associated multi-way valve assembly for selectively connecting upstream to either a cartridge socket reagent line or an external reagent input line; wherein the plurality of pressure feed lines originate from a shared external pressure input connector; the plurality of external pressure output lines terminate in a shared external pressure output connector; the plurality of external reagent input lines originate from a shared external reagent input connector; the plurality of reagent output lines terminate in a shared reagent output connector; the external pressure input connector is fluidly connected to the external pressure output connector of the master microfluidic module, and the external reagent output connector is fluidly connected to the external reagent input connector of the master microfluidic module.
As seen above in the rejection of Claim 1, the elements in Claim 4 are all the same but within the second microfluidic module.
As mentioned above even though the reference teaches one microfluidic module, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the number of modules and its parts including the cartridge socket, pressure manifold and reagent manifold to increase the number of samples to be measured simultaneously creating a higher throughput of the device and as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Additional Disclosures Included are: Claim 5: wherein the measurement device according to claim 4, wherein the reagent manifold comprises a fluidic chip socket, having a plurality of fluidic chip socket inlet ports and fluidic chip socket outlet ports, each fluidic chip socket inlet port being connected to said associated multi-way valve assembly, for selectively connecting the chip input line to either the cartridge socket reagent line or the external reagent input line, and each outlet port being fluidly connected to said reagent output line, Figure 6 and 8, Column 9 line 47-Column 8 line 67.; and Claim 6: wherein the measurement device according to claim 5, further comprising a fluidic chip plugged into said fluidic chip socket, Figure 9, overall device are connected/coupled to each other.
Regarding Claim 7, the ILLUMINA reference suggests the measurement device according to claim 4, but is silent in regards to wherein the at least two of said secondary microfluidic modules attached to the master microfluidic module in a daisy chain configuration, such that the external pressure input connector of secondary microfluidic module 1+1 is connected to the external pressure output connector of secondary microfluidic module 1; and the external reagent output connector of secondary module 1+1 is connected to the external reagent input connector of secondary microfluidic module 1, where 1 is greater than or equal to 1.
It would be obvious to one having ordinary skill in the art before the effective filing date to orientate the at least two of said secondary microfluidic modules attached to the master microfluidic module in a daisy chain configuration to allow for synchronous serial communication and allows for increase of scalability of sampling.
Regarding Claim 8, the ILLUMINA reference suggest the measurement device according to claim 2, but is silent wherein said connectors of the master microfluidic module are connected to said connectors of the at least one secondary microfluidic module through a linker Column 5 line 7-20.
Regarding Claim 30, the reference ILLUMINA discloses the measurement device according to claim 2, further comprising a reagent cartridge plugged into the cartridge socket of at least one secondary microfluidic module, Figure 6, Column 9 line 48 – Column 10 line 39.
Regarding Claim 31, the reference ILLUMINA discloses the measurement device according to claim 30, wherein the reagent cartridge comprises a housing having a mating surface contacting the cartridge socket of the master microfluidic module, the housing containing:- a plurality of reagent reservoirs (optionally provided as part of a detachable reagent tray/module as described above);- a plurality of cartridge pressurisation ports (connected to the cartridge socket inlet ports when installed on a microfluidic module) in fluid communication with the reagent reservoirs, for pressurising the reagent reservoirs in use:- a plurality of cartridge outlet ports (connected to the cartridge socket outlet ports when installed on a microfluidic module), for dispensing reagent from the cartridge in use; and- a valve assembly, for regulating flow of reagents from the reagent reservoirs to the cartridge outlet ports in use, the valve assembly comprising: o a stator chip assembly, having a plurality of reagent channels each providing a flowpath from the reagent reservoirs to the cartridge outlet ports, each reagent channel having an associated valve section in which the reagent channel is capped with a flexible membrane ; o a valve actuator, comprising a plurality of pins which are movable to actuate the valve sections between an open position in which the reagent channel is open and a closed position in which the flexible membrane is deformed so as to occlude the reagent channel; and a rotor chip, rotatable relative to the valve actuator between a first position and a second position, wherein the rotor chip includes an actuator surface which pushes the pins to actuate the valve sections, and wherein said rotation causes the actuator surface to actuate (open/close) a different subset of the valve sections in the first position compared to the second position, See Rejection and citation to Claim 26. Examiner’s Note: the underline portion above is the same as seen in original Claim 26.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797