DETAILED ACTION
In application filed on 08/01/2024, Claims 1-20 are pending. The claim set submitted on 08/01/2024, is considered because this is the most recent claim set. Claims 1-20 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/31/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The claim set uses a substitute for “mechanism”
The claim set generic placeholder is modified by functional language: “to move”.
Claim 1 recites “the drive mechanism, to move”.
Based on the instant specification:
“drive mechanism” has been interpreted in light of the specification to comprise a screw drive with a screw 1744 [See Para 0078].
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 § 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 1-8 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Davey et al. (US20120143531A1, submitted in IDS on 10/31/2024) in view of Anderson et al. (US20110201099A1).
Regarding Claim 1, Davey teaches a method of applying a fluid composition (‘reagent solution’) (See Abstract…a fluidic subsystem to exchange a reagent solution with the sensor cartridge) to a flow cell (referred to as a flow cell [Para 0036, Fig. 1A, ref 105) of a sensor device (See Abstract, Para 0088…the sensor cartridge (1002)), the method comprising:
inserting the sensor device (referred to as sensor cartridge [Para 0076; Fig. 9A, ref. 904]) into a holder (referred to as socket [Para 0076; Fig. 9A, ref. 906]);
engaging (See Para 0045… a manifold (151) may be formed in the flow cell assembly, thereby teaching “engaging”) a fluidic coupler (referred to as manifold 151 [Para 0045]) with the flow cell (referred to as a flow cell [Para 0036, Fig. 1A, ref 105) using a mechanical assembly (referred to as clamp member [Para 0087; 0088; Fig. 9A, ref. 902]; See Para 0064…other means of connecting a flow cell to a fluidics system may be used, including other types of pressure fittings, clamp-based fittings,) including a drive mechanism (See Para 0065…other means of connecting a flow cell to a fluidics system may be used, including other types of …screw-on fittings, thereby teaching “screw-on fittings) ; and
engage (See Para 0045… a manifold (151) may be formed in the flow cell assembly, thereby teaching “engage”) the fluidic coupler (referred to as manifold 151 [Para 0045]) with the flow cell (referred to as a flow cell [Para 0036, Fig. 1A, ref 105);
pipetting an aliquot (See Para 0086…(such as a 1 mm outer diameter tapered pipette tip)), thereby teaching “an aliquot”) of the fluid composition (See Para 0086…as fluidic/reagent introduction or withdrawal) into a pipette tip (See Para 0086…These operations may include manual activities such as pipetting into the flowcell ports which may be made accessible to the user when the clamping mechanism is in the open position… Furthermore, the sensor or flowcell ports may be designed to accept, mate with or seal with components having standardized dimensions (such as a 1 mm outer diameter tapered pipette tip)); and
applying the aliquot (See Para 0086…(such as a 1 mm outer diameter tapered pipette tip)), thereby teaching “an aliquot”) of the fluid composition (See Para 0086…as fluidic/reagent introduction or withdrawal) to an opening (referred to as ‘conduits and passages’ [Para 0084]) of a fluidic connector ((See Para 0084, 0087; Fig. 10A, ref. 1005…‘fluid connectors’) engaged with the flow cell (See Para 0086… flowcell ports) of the sensor device (See Para 0088…the sensor cartridge (1002) (See Para 0084…Returning to FIG. 9A, clamp member (902) may comprise conduits (922 and 924) and passages (not illustrated) for transferring fluid through fluid connectors (exemplary element 928 shown) into and out of sensor cartridge (904) through inlet (916) and outlet (918) when in a clamp-closed configuration; See Para 0086…pipetting into the flowcell ports which may be made accessible to the user when the clamping mechanism is in the open position; See Para 0088…Clamp member (1000) further serves as a fluid manifold for delivering reagents to and from sensor cartridge (1002) through conduit (1024) and other conduits not shown), the fluidic connector (See Para 0084, 0087; Fig. 10A, ref. 1005…‘fluid connectors’) including:
a body (See Para 0084, 0087; Fig. 10A, ref. 1005…‘fluid connectors’); Examiner submits that under BRI, the fluid connector(s) have a physical embodiment; Also See Para 0043; Fig. 1B and 1E, ref. 131 for the embodiment of the flow cell apparatus, thereby teaching “body”); and
a plurality of fluidic interface (referred to as a Tee connector [Para 0043; Fig. 1B, ref. 137] and the a cross-connector [Para 0050; Fig. 1E, ref. 171]) formed in the body See Para 0084, 0087; Fig. 10A, ref. 1005…‘fluid connectors’); Examiner submits that under BRI, the fluid connector(s) have a physical embodiment; Also See Para 0043; Fig. 1B and 1E, ref. 131 for the embodiment of the flow cell apparatus, thereby teaching “body”); and
each fluidic interface (referred to as a Tee connector [Para 0043; Fig. 1B, ref. 137] and the a cross-connector [Para 0050; Fig. 1E, ref. 171]) of the plurality of fluidics interfaces (referred to as a Tee connector [Para 0043; Fig. 1B, ref. 137] and the a cross-connector [Para 0050; Fig. 1E, ref. 171]) includes an opening (referred to as inlet port [Para 0050]; and inlet port [Para 0043]), a first port (referred to as a first port (172) [Para 0050]; and first port (136) [Para 0043]) in fluid communication (See Para 0050…a first port (172) coupled onto the inlet port; See Figs. 1B and 1E for fluidic communication; Also See Para 0091…a fluid manifold 1050 includes ports) with the opening (referred to as inlet port [Para 0050]; and inlet port [Para 0043]), a second port (referred to as a second port (173) [Para 0050]; and an outlet port (134) [Para 0043]; Also See Para 0091…a fluid manifold 1050 includes ports), and a third port (referred to as a third port (174) is used as a waste outlet port [Para 0050; Fig. 1E, ref. 174]; and third port (144) [Para 0044])) in communication (See Fig. 1E for the fluidic communication) with the second port (referred to as a second port (173) [Para 0050]; and an outlet port (134) [Para 0043]; Also See Para 0091…a fluid manifold 1050 includes ports).
Davey does not teach:
“a mechanical assembly including a drive mechanism and a frame;
actuating the drive mechanism to move the frame and engage the fluidic coupler with the flow cell; and
a plurality of fluidics interfaces formed in the body.
In the analogous art of assay cartridges that have a detection chamber, Anderson teaches:
“a mechanical assembly (referred to as actuator [Para 0026]) including a drive mechanism (See Para 0026… a motor and a lead screw cooperating with a lead screw nut; See Fig. 43 a ) and a frame (referred to as cartridge tray [Para 0026]);
actuating the drive mechanism to move the frame (See Para 0026… an actuator to move the cartridge tray along the rail) and engage the fluidic coupler with the flow cell; and
a plurality of fluidics interfaces (referred to as fluidic connectors [Para 0026]) formed in the body (referred to as one or morereader components [Para 0026], thereby teaching “body”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Davey to include “a mechanical assembly including a drive mechanism and a frame; actuating the drive mechanism to move the frame and engage the fluidic coupler with the flow cell; and a plurality of fluidics interfaces formed in the body, as taught by Anderson for the benefit of configuring a cartridge reader to analyze an assay conducted in an assay cartridge (Anderson, Para 0026), allowing for developing point of care diagnostic systems that are small enough and easy enough to use so that they can be used by unskilled operators in decentralized clinical settings, but at the same time maintaining the low cost, diverse assay menu, and/or high performance of tests carried out on traditional clinical analyzers in central laboratories (Anderson, Para 0005).
Regarding Claim 2, the method of claim 1 is obvious over Davey in view of Anderson.
Davey further teaches that the sensor device (referred to as sensor cartridge [Para 0076; Fig. 9A, ref. 904]) is disposed (See Fig. 9a…’disposed’; See Para 0094… a socket, to engage a sensor cartridge) in the holder (referred to as socket [Para 0076; Fig. 9A, ref. 906]) in a vertical orientation (See Fig. 9A for the arrow depicting the vertical orientation).
Regarding Claim 3, the method of claim 1 is obvious over Davey in view of Anderson.
Davey further teaches drawing (See Para 0036…The reagents may be driven through the fluid pathways, valves and flow cell by pumps, by gas pressure, or other conventional methods, thereby teaching “drawing”) a remainder of the aliquot (‘reagents to be discarded’) of the fluid composition (See Para 0036… Reagents are discarded into a waste container (106) after exiting flow cell and sensor array (100)) from the third port (See Para 0050… A third port (174) is used as a waste outlet port.)
Regarding Claim 4, the method of claim 3 is obvious over Davey in view of Anderson.
Davey further teaches wherein drawing (See Para 0036…The reagents may be driven through the fluid pathways, valves and flow cell by pumps, by gas pressure, or other conventional methods, thereby teaching “drawing”) the remainder of the aliquot (See Para 0036…‘reagents to be discarded’) include applying a vacuum (See Para 0036…The reagents may be driven through the fluid pathways, valves and flow cell by pumps, by gas pressure, or other conventional methods, thereby teaching “applying a vacuum”; See Para 0117… Reagents from reservoirs (704, 706, 708, 710, and 712) may be driven to fluidic circuit (702) by a variety of methods including pressure, pumps, such as syringe pumps, gravity feed, and the like, and are selected by control of valves (714).) to the third port (See Para 0050… A third port (174) is used as a waste outlet port).
Regarding Claim 5, the method of claim 1 is obvious over Davey in view of Anderson.
Davey further teaches inserting (See Para 0089… the chip clamp (1000) may be positioned in an open position through the use of the actuator assembly or lever (1008) to disengage the fluid manifold (1050), thereby teaching “inserting”; Examiner submits under BRI that “inserting” is present before “disengage”) the fluidic coupler (referred to as manifold 151 [Para 0045]) into a mechanical assembly (referred to as clamp member [Para 0087; 0088; Fig. 9A, ref. 902]) when the mechanical assembly (referred to as clamp member [Para 0087; 0088]) is in a first position (See Para 0087…As exemplified in FIG. 10A, clamp member (1000) may be positioned in a substantially open position, thereby teaching “first position” ), the mechanical assembly (referred to as clamp member [Para 0087; 0088]) moveable between the first position (referred to as open position [Para 0087]) and a second position (See Para 0088…the clamp member shown in a substantially closed position).
Regarding Claim 6, the method of claim 5 is obvious over Davey in view of Anderson.
Davey further teaches moving (See Para 0084… when in a clamp-closed configuration) the mechanical assembly (referred to as clamp member [Para 0087; 0088]) to the second position (See Para 0088…the clamp member shown in a substantially closed position), whereby the fluidic coupler (referred to as manifold 151 [Para 0045]) engages (See Para 0045…a manifold (151) may be formed in the flow cell assembly) the flow cell (See Para 0086… flowcell ports) of the sensor device (See Para 0088…the sensor cartridge (1002)).
Regarding Claim 7, the method of claim 5 is obvious over Davey in view of Anderson.
Davey further teaches moving (See Fig. 9A for the alignment, thereby teaching “moving”; Also See Fig. 10A… depicting an exemplary relative positioning of the components with respect to one another) the holder (referred to as socket [Para 0076; Fig. 9A, ref. 906]) into position adjacent (See Fig. 9A for the position adjacent) the mechanical assembly (referred to as clamp member [Para 0087; 0088; Fig. 9A, ref 902]).
Regarding Claim 8, the method of claim 5 is obvious over Davey in view of Anderson.
Davey further teaches wherein the mechanical assembly (referred to as clamp member [Para 0076, 0087; 0088; Fig. 9A, ref. 902; Fig. 10A, ref. 1000]) including a set of guide rods (referred to as tapered fluid-port bosses [Para 0085]) to the reference holes (referred to as tapered fluid-port bosses or receivers [Para 0085, where receivers thereby teaches “reference holes”; See Para 0085… To facilitate fluidic engagement with the sensor chip (1002) tapered fluid-port bosses or receivers may be utilized to facilitate engagement of the fluidic ports and provide a self-aligning feature for the fluid connections; See Para 0158…a manifold having fluid ports to engage the sensor cartridge, thereby teaching “reference holes as the “fluid ports”) of the fluidic coupler (referred to as manifold 151 [Para 0045]; See Para 0100…) when the mechanical assembly (referred to as clamp member [Para 0076, 0087; 0088; Fig. 9A, ref. 902; Fig. 10A, ref. 1000]) is moved from the first position (referred to as open position [Para 0087]) and a second position (See Para 0088…the clamp member shown in a substantially closed position; Also See Figs. 10A-B for the open and closed position of the Clamp member (1000)).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Davey et al. (US20120143531A1, submitted in IDS on 10/31/2024) in view of Anderson et al. (US20110201099A1), as applied to claim 8 above, and further in view of Victor et al. (US6319476B1).
Regarding Claim 9, the method of claim 8 is obvious over Davey in view of Anderson.
The combination of Davey and Anderson does not explicitly teach that the body defines reference holes to receive the guide rods.
In the analogous art of a system and method for integrating microfluidic components in a microfluidic system enables the microfluidic system to perform a selected microfluidic function, Victor teaches that the body (referred to as preferred fluid connector [Fig. 1, ref. 10]) defines reference holes (referred to as alignment bores [Fig. 1, refs 34 and 36]) to receive the guide rods (referred to as alignment bores [Fig. 1, refs 34A and 36A]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Davey and Anderson to include that the body defines reference holes to receive the guide rods, as taught by Victor for the benefit of allowing tubing 20 to be aligned with port 30 (Victor, Col. 5, lines 29-32), providing an applied force sufficient to create a face seal (Victor, Col. 5, lines 36-40), allowing for the provision of low cost, high pressure seal which is easily removable and reusable. Moreover, the present invention provides a self-aligning connection which readily is adapted to individual microchip assemblies having a high fitting density (Victor, lines Col. 3, 23-27).
Regarding Claim 10, the method of claim 9 is obvious over Davey in view of Anderson and further in view of Victor.
The combination of Davey and Anderson does not explicitly teach that the body defines wings and the reference holes are defined in the wings.
In the analogous art of a system and method for integrating microfluidic components in a microfluidic system enables the microfluidic system to perform a selected microfluidic function, Victor teaches that the body (referred to as preferred fluid connector [Fig. 1, ref. 10]) defines wings (See Annotated Fig. 1, thereby teaching “wings”) and the reference holes (referred to as alignment bores [Fig. 1, refs 34 and 36]) are defined in the wings (See Annotated Fig. 1, thereby teaching “wings”).
In addition, Examiner submits that the claimed “wings” is not specifically defined in the specification and will therefore be given the broadest reasonable interpretation in light of the specification. Any shape that has a rectangular or square form that will be considered “wings”. As such, the shape of the mating top plates would satisfy “wings”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Davey and Anderson to include that the body defines wings and the reference holes are defined in the wings, as taught by Victor for the benefit of allowing tubing 20 to be aligned with port 30 (Victor, Col. 5, lines 29-32), providing an applied force sufficient to create a face seal (Victor, Col. 5, lines 36-40), allowing for the provision of low cost, high pressure seal which is easily removable and reusable. Moreover, the present invention provides a self-aligning connection which readily is adapted to individual microchip assemblies having a high fitting density (Victor, lines Col. 3, 23-27).
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Annotated Fig. 1, Victor
Regarding Claim 11, the method of claim 9 is obvious over Davey in view of Anderson and further in view of Victor.
Davey teaches a lever (See Para 0087; Fig. 10A, ref. 1008… The clamp member (1000) may further be operationally associated with a mechanical forcing element comprising a spring-actuated self-locking mechanism operated by lever (1008)).
The combination of Davey and Anderson does not teach that a guide rod of the set of guide rods is responsive to a lever of the mechanical assembly.
In the analogous art of a system and method for integrating microfluidic components in a microfluidic system enables the microfluidic system to perform a selected microfluidic function, Victor teaches that a guide rod (referred to as one of the pins [Fig. 1, refs 34A and 36A]) of the set of guide rods (referred to as pins [Fig. 1, refs 34A and 36A]) is responsive to a lever (See …turning of the compression screw 19; See Col. 5, ref. 34-35… under BRI, Examiner submits that when operated, a screw often functions using a lever principle. ) of the mechanical assembly (referred to as housing [Fig. 1, ref. 11]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Davey and Anderson to include that a guide rod of the set of guide rods is responsive to a lever of the mechanical assembly, as taught by Victor for the benefit of generating a force sufficient to compress an elastic number, i.e., spring 23 (Victor, Col. 5, lines 34-35) ,allowing for the provision of low cost, high pressure seal which is easily removable and reusable. Moreover, the present invention provides a self-aligning connection which readily is adapted to individual microchip assemblies having a high fitting density (Victor, lines Col. 3, 23-27).
Regarding Claim 12, the method of claim 11 is obvious over Davey in view of Anderson and further in view of Victor.
Davey further teaches the mechanical assembly (referred to as clamp member [Para 0087; 0088; Fig. 9A, ref. 902]) further comprising a spring (referred to as compression soring assembly [Para 0087]) in contact with the lever (See Para 0087… where the actuator (1008) operates in connection with a compression spring assembly (1022) motivating the lever (See Para 0087… where the actuator (1008) operates in connection with a compression spring assembly (1022) to move the guide rod (referred to as tapered fluid-port bosses [Para 0085]) forward (See Para 0085…To facilitate fluidic engagement with the sensor chip (1002) tapered fluid-port bosses or receivers may be utilized to facilitate engagement of the fluidic ports and provide a self-aligning feature for the fluid connections; See Para 0087… One embodiment of such a mechanism is exemplified in FIGS. 10A-10G where the actuator (1008) operates in connection with a compression spring assembly (1022) such that in the closed position the assembly may be “locked” into position to insure positive fluidic or electrical connectivity, thereby teaching “forward”.
Regarding Claim 13, the method of claim 1 is obvious over Davey in view of Anderson
Davey further teaches that the first port (referred to as a first port (172) [Para 0050]; Also See Para 0091…a fluid manifold includes ports) and the second port (referred to as a second port (173) [Para 0050; Also See Para 0091…a fluid manifold 1050 includes ports) include seals (See Para 0091…The ports 1005 can include elastomeric seals illustrated as 1014 in FIG. 10B; See Para 0085…these fluid-ports may further comprise elastomeric seals or gaskets (exemplified in FIG. 10C) to further enhance or improve the sealing or leak resistance of the system) formed of resilient material (See Para 0091… elastomeric seals, thereby teaching “resilient material”).
Regarding Claim 14, the method of claim 13 is obvious over Davey in view of Anderson.
Davey further teaches that the resilient material (See Para 0091… elastomeric seals, thereby teaching “resilient material”) is an overmold (See Para 0091… elastomeric seals, thereby teaching “resilient material”; Examiner further submits that elastomers are primary materials used in overmolding).
Regarding Claim 15, the method of claim 1 is obvious over Davey in view of Anderson.
Davey further teaches that the opening (referred to as inlet port [Para 0050]; and inlet port [Para 0043]) is configured to receive fluid (See Para 0043… That is, the reagent fluids are introduced into port (133) via conduit (134) from a pipette tip (See Para 0086…These operations may include manual activities such as pipetting into the flowcell ports which may be made accessible to the user when the clamping mechanism is in the open position. Furthermore, the sensor or flowcell ports may be designed to accept, mate with or seal with components having standardized dimensions (such as a 1 mm outer diameter tapered pipette tip).
Regarding Claim 16, the method of claim 1 is obvious over Davey in view of Anderson.
Davey further teaches the opening (referred to as ‘conduits and passages’ [Para 0084]) and the top of the fluidic coupler (referred to as manifold 151 [Para 0045]; or fluid manifold [Fig. 10C-D ;Para 0089); Under BRI, the fluid manifold has a top].
Davey does not explicitly teach that the opening is disposed on top of the fluidic coupler.
In the analogous art of assay cartridges that have a detection chamber, Anderson teaches that the opening (See Annotated Fig. 43(b) for the embodiment of the tube or channel or pipe connected to the fluidic manifold) is disposed on top (See Annotated Fig. 43(b) for the top) of the fluidic coupler (referred to as fluidic manifold [Para 0315; Fig.43 (b), ref. 4360)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Davey to include that the opening is disposed on top of the fluidic coupler, as taught by Anderson for the benefit of providing fluidic connectors (not shown) that mate to the vent ports in the cartridge when the cartridge is fully inserted, e.g., using gaskets or O-rings to provide leak-free seals (Anderson, Para 0315), allowing for developing point of care diagnostic systems that are small enough and easy enough to use so that they can be used by unskilled operators in decentralized clinical settings, but at the same time maintaining the low cost, diverse assay menu, and/or high performance of tests carried out on traditional clinical analyzers in central laboratories (Anderson, Para 0005).
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Annotated Fig. 43(b), Anderson
Regarding Claim 17, the method of claim 1 is obvious over Davey in view of Anderson.
Davey teaches that the first (referred to as a first port (172) [Para 0050]; and first port (136) [Para 0043]; Also See Para 0091…a fluid manifold includes ports) and second port (referred to as a second port (173) [Para 0050]; and an outlet port (134) [Para 0043]; Also See Para 0091…a fluid manifold 1050 includes ports) are disposed on a first side (See Fig. 10C for the first side of the ports 1005 ) of the fluidic coupler (referred to as manifold 151 [Para 0045]; or fluid manifold [Fig. 10C-D, ref 1050 ;Para 0089]).
Regarding Claim 18, the method of claim 17 is obvious over Davey in view of Anderson.
Davey teaches the third port (referred to as a third port (174) is used as a waste outlet port [Para 0050; Fig. 1E, ref. 174]; and third port (144) [Para 0044]) and the fluidic coupler (referred to as manifold 151 [Para 0045]; or fluid manifold [Fig. 10C-D, ref 1050 ;Para 0089]).
The combination of Davey and Anderson does not explicit teach that the third port is disposed on a second side of the fluidic coupler opposite the first side.
In the analogous art of a system and method for integrating microfluidic components in a microfluidic system enables the microfluidic system to perform a selected microfluidic function, Victor teaches that the third port (referred to as the fluid-carrying conduit 66 [Fig. 4, ref. 66 ]) is disposed on a second side (See Annotated Fig. 4) of the fluidic coupler (Col. 5, lines 64-65; See Fig. 4…FIG. 4 shows another embodiment of the invention for connecting at least two connectors to a microfluidic device) opposite the first side (See Annotated Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Davey and Anderson to include that the third port is disposed on a second side of the fluidic coupler opposite the first side, as taught by Victor for the benefit of delivering fluid to the microfluidic channel 67 (Victor, Col. 6, lines 17-18), allowing for the provision of low cost, high pressure seal which is easily removable and reusable. Moreover, the present invention provides a self-aligning connection which readily is adapted to individual microchip assemblies having a high fitting density (Victor, lines Col. 3, 23-27).
Regarding Claim 19, the method of claim 1 is obvious over Davey in view of Anderson.
Davey teaches wherein the fluidic coupler (referred to as manifold 151 [Para 0045]; or fluid manifold [Fig. 10C-D, ref 1050 ;Para 0089]) includes (See Para 0084…through fluid connectors (exemplary element 928 shown) into and out of sensor cartridge; See Para 0094…A fluidics subsystem can engage the sensor cartridge, such as through a manifold, thereby teaching “includes” ) the fluidic connector (See Para 0084, 0087; Fig. 10A, ref. 1005…‘fluid connectors’).
The combination of Davey and Anderson does not explicit teach that the fluidic connector further comprising a fourth port in fluid communication with the first port.
In the analogous art of a system and method for integrating microfluidic components in a microfluidic system enables the microfluidic system to perform a selected microfluidic function, Victor teaches that the fluidic connector (Col. 5, lines 64-65; See Fig. 4…FIG. 4 shows another embodiment of the invention for connecting at least two connectors to a microfluidic device) further comprising a fourth port (referred to as the fluid-carrying conduit 66 [Fig. 4, ref. 68]) in fluid communication (See Col. 6, lines 17-19… fluid-carrying conduit 66 is a fluid inlet to microfluidic channel 67, and fluid-carrying conduit 68 is a fluid outlet.) with the first port (referred to as surrounding port 2 [Fig. 4, ref. 27]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Davey and Anderson to include that the fluidic connector further comprising a fourth port in fluid communication with the first port, as taught by Victor for the benefit of delivering fluid to the microfluidic channel 67 (Victor, Col. 6, lines 17-18), allowing for the provision of low cost, high pressure seal which is easily removable and reusable. Moreover, the present invention provides a self-aligning connection which readily is adapted to individual microchip assemblies having a high fitting density (Victor, lines Col. 3, 23-27).
Regarding Claim 20, the method of claim 19 is obvious over Davey in view of Anderson and further in view of Victor.
Davey teaches that the first port (referred to as a first port (172) [Para 0050]; and first port (136) [Para 0043]; Also See Para 0091…a fluid manifold includes ports) is disposed on a first side (See Fig. 10C for the first side of the ports 1005) of the fluidic coupler (referred to as manifold 151 [Para 0045]; or fluid manifold [Fig. 10C-D, ref 1050 ;Para 0089]).
Davey does not explicit teach that the fourth port is disposed on a second side of the fluidic coupler opposite the first side.
In the analogous art of a system and method for integrating microfluidic components in a microfluidic system enables the microfluidic system to perform a selected microfluidic function, Victor teaches that the fourth port (referred to as the fluid-carrying conduit 66 [Fig. 4, ref. 68]) is disposed on a second side (Annotated Fig. 4) of the fluidic coupler (Col. 5, lines 64-65; See Fig. 4…FIG. 4 shows another embodiment of the invention for connecting at least two connectors to a microfluidic device) opposite the first side (Annotated Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a method of Davey to include that the fourth port is disposed on a second side of the fluidic coupler opposite the first side, as taught by Victor for the benefit of providing a controlled path for fluid to exit the microfluidic channel 67 (Victor, Col. 6, lines 17-20), allowing for the provision of low cost, high pressure seal which is easily removable and reusable. Moreover, the present invention provides a self-aligning connection which readily is adapted to individual microchip assemblies having a high fitting density (Victor, lines Col. 3, 23-27).
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Annotated Fig. 4, Victor
Response to Arguments
Applicant’s arguments, see Page 6, filed 07/28/2026, with respect to the objections on Claim 4 have been fully considered and are persuasive. Therefore, the objection is withdrawn.
Applicant submits that claim 4 has been amended to recite "the remainder of the aliquot", thereby correcting the noted informality.
Examiner submits that Applicant’s arguments with respect to the objections on Claim 41 has been considered and the objection is withdrawn.
Applicant’s arguments, see Page 6, filed 07/28/2026, with respect to the rejection(s) of claim(s) 4, 16-18 and 20 (inclusion of Claim 4 is a typographical error, rendering the rejection of Claim 4 moot) under 35 U.S.C. §112 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Examiner notes that the inclusion of Claim 4 in the 112b rejection in the Non- Final Rejection (04/29/2026) is a typographical error. The 112b rejection applies only to Claims 16-18 and 20. As a result, Applicant’s argument with respect to claim 4 is moot and thus not required.
With respect to claims 16-18 and 20, Applicant respectfully submits that the amended claim language now clearly recites distinct structures, including the fluidic connector and the fluidic coupler, and that, when read in light of the specification, the scope of the claims would be reasonably understood by a person of ordinary skill in the art. Applicant therefore respectfully submits that the pending claims particularly point out and distinctly claim the subject matter regarded as the invention and respectfully requests withdrawal of the rejection under 35 U.S.C. §112(b).
Examiner submits that Applicant’s arguments with respect to the rejection(s) of claim(s) 4, 16-18 and 20 (Claim 4 is not included) under 35 U.S.C. §112 have been fully considered, persuasive and rejection is withdrawn.
Applicant’s arguments, see Page 6, filed 07/28/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. §103 (have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made for amended Claim 1 by Davey et al. (US20120143531A1, submitted in IDS on 10/31/2024) in view of Anderson et al. (US20110201099A1).
Applicant submits that independent claim 1 has been amended to further recite, inter alia:
"...engaging a fluidic coupler with the flow cell using a mechanical assembly including a drive mechanism and a frame; actuating the drive mechanism to move the frame and engage the fluidic coupler with the flow cell..."
Foregoing amendments further specify the manner in which the fluidic coupler is engaged with the flow cell. Neither Davey nor Victor, alone or in combination, teaches or suggests the foregoing amendments. Office Action relies on Davey for a movable clamp assembly and upon Victor for features of a fluidic coupling interface. However, the cited combination does not disclose or suggest performing the claimed method using the recited mechanical assembly as now claimed. Nor does the Office Action identify where the cited references disclose or suggest the recited mechanical assembly architecture employed in the claimed method.
Accordingly, the pending independent claim is directed to subject matter that is not taught or suggested by the cited references. For at least these reasons, Applicant respectfully submits that the rejection under 35 U.S.C. §103 should be withdrawn.
Applicant’s arguments with respect to amended claim 1 has been considered and Examiner respectfully disagrees.
Examiner submits that the limitations of amended Claim 1 is taught as disclosed in the rejection of amended Claim 1 (Supra) by Davey et al. (US20120143531A1, submitted in IDS on 10/31/2024) in view of Anderson et al. (US20110201099A1).
Further, a rejection for pending Claims 2-20 is provided in the office action in view of the rejection of amended Claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/Examiner, Art Unit 1797
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