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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/26/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 26 August 2025.
Claims 1, 3-12, 16-17, and 21-31 are pending.
Claims 2, 13-15, and 18-20 are cancelled.
No claims are withdrawn.
Claims 23-31 are newly added.
Claim Objections
Claims 21-22 recite “the vibration isolation assembly comprises” while Claim 16, on which Claims 21-22 depend, recites that the vibration is olation assembly comprises a housing. While “comprises” is open-ended, for clarity Applicant may wish to amend Claims 21-22 to recite “the vibration isolation assembly further comprises”.
Similarly, Applicant may wish to amend Claim 6 to recite “the manifold assembly further comprises”.
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 valve drive assembly adapted to interface” as in Claim 1.
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.
“a brushless motor” as in para. [0012] of Applicant’s instant specification filed 06/29/2022.
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.
Claim 1 and dependents thereof are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a system including a reagent cartridge receptacle” wherein the system and its receptacle do not appear to be structurally or functionally related to any other part of the device by the claim. If it is Applicant’s intent that the system comprises the reagent cartridge receptacle, the flow cell receptacle, the manifold assembly, etc., Applicant may wish to replace the semicolons separating these elements with commas, or for maximum clarity, recite the system “further comprising”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 17 requires that the reagent selector valve be disposed within the flow cell receptacle. However, Claim 16, on which Claim 17 directly depends, recites the manifold being positioned within he flow cell receptacle, wherein the manifold comprises the reagent selector valve. Thus, the limitation of Claim 17 is already present within Claim 16 by way of the manifold position and composition.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 6-8, 12, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Drews et al. (US 2018/0187259 A1), referred to hereinafter as “Drews”, in view of Kato et al. (US 2019/0329240 A1), referred to hereinafter as “Kato”, Servin et al. (US PAT 8,622,086 B2), hereinafter “Servin”, and Liang (CN 101008455 A – as seen through the machine translation available on Google Patents and attached herein), hereinafter “Liang”.
Regarding Claim 1, Drews teaches an apparatus, comprising:
a system including a reagent cartridge receptacle ([0065] teaches reagent cartridges. By this, there must necessarily exist a receptacle for receiving said cartridges.) to receive a reagent cartridge comprising a plurality of reagent reservoirs (As the reagent cartridge receptacle is configured to receive a reagent cartridge, said receptacle is fully capable of receiving a cartridge having plural reagent reservoirs. The recitation “to receive” merely describes a capability and intended use of the receptacle, wherein the “a reagent cartridge comprising a plurality of reagent reservoir” is recited by way of such capability and is thereby not a positively claimed element. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II).);
a flow cell receptacle 22 to receive a flow cell assembly 20 (Fig. 1 and [0036]: “the flow cell 20 is mounted on a movable stage 22” – See also [0036]: “The flow cell 20 may, for example, be provided in the form of a removable and replaceable cartridge that may interface with ports on the movable stage 22 or other components of the system in order to allow reagents and other fluids to be delivered to or from the flow cell 20.” – Further, similarly as above, the recitation “to receive” merely describes a capability and intended use of the receptacle, wherein the “a flow cell assembly” is recited by way of such capability and is thereby not a positively claimed element.);
and a manifold assembly 66/68, the manifold assembly 66/68 comprising a reagent selector valve 66 adapted to be fluidically coupled to the reagent reservoirs 64 (Fig. 2 and [0042]: “A reagent selector valve 66 is mechanically coupled to a motor or actuator (not shown) to allow selection of one or more of the reagents to be introduced into the flow cell.”) the manifold assembly 66/68 comprising a flow cell interface, the flow cell interface comprising a surface defining an opening of a flow cell fluidic line to selectively flow reagent from a corresponding reagent reservoir 64 to the flow cell assembly 20 (The side surface of the reagent selection valve opening to the flow cell fluidic line connecting to the common line selection valve for fluidically interfacing with the flow cell.),
a valve drive assembly adapted to interface with and be coupled adjacent to an end of the reagent selector valve (Fig. 2 and [0046]: “…the control system 46 employs one or more valve interfaces 84 which are configured to provide command signals for the valves…” – As the valves are electronically commanded, said valves must necessarily comprise drivers for actuating the valves.),
as in Claim 1.
Further regarding Claim 1, Drews does not specifically teach the apparatus discussed above wherein the manifold assembly is positioned within the flow cell receptacle, as in Claim 1.
However, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Therein, one skilled in the art would find it obvious that the device having the claimed relative arrangement of separate manifold assembly and flow cell receptacle would not perform differently than the prior art device given the manifold and flow cell assemblies perform the identical function regardless of their relative positioning, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the manifold assembly being within the flow cell assembly.
Further regarding Claim 1, if the “a reagent cartridge” were to be recited as a positive element (see above regarding its current recitation as a mere capability of the reagent cartridge receptacle): Drews does not specifically teach the apparatus discussed above wherein the reagent cartridge comprises a plurality of reagent reservoirs, as in Claim 1.
However, Kato teaches a respective flow cell apparatus wherein a reagent cartridge 1001 holds a plurality of reagents 1002 for delivery to a flow cell 1004 (Fig. 9 and [0055]: “…a reagent cartridge 1001 has a structure that can hold a plurality of reagents 1002.”). As both Kato and Drews similarly teach fluid handling from reagent vessels to a flow cell, the multi-reagent cartridge of Kato merely represents an obvious alternative to the multiple single-reagent cartridges of Drews.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews to include a reagent cartridge comprising a plurality of reagent reservoirs, such as suggested by Kato, as the assembly of Kato represents an obvious alternative arrangement, wherein both alternatives commonly serve to store reagents for delivery to a flow cell.
Further regarding Claim 1, Drews does not specifically teach the apparatus discussed above wherein at least a surface of the flow cell interface is to be directly mechanically coupled to a portion of the flow cell assembly, as in Claim 1.
However, merely making integral as one piece what exists in the prior art as separate pieces absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04 (V)(B). Herein, one of ordinary skill in the art would find that the prior art device having a reagent selector valve and flow cell assembly as separate pieces within the apparatus would not function differently than the claimed integral reagent selector valve and flow cell assembly, thus representing an obvious matter of design choice.
Examiner further notes that Applicant’s amendment reciting “is to be” signals functional language and intended use of the flow cell interface. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the flow cell interface of Drews is fully capable of being directly mechanically coupled to a portion of the flow cell assembly, absent evidence to the contrary. Further, the “flow cell assembly”, as discussed above, is not a positive element of the device, thus the limitation “is to be directly mechanically coupled to a portion of the flow cell assembly” does not hold patentable weight.
Further regarding Claim 1, Drews does not specifically teach the apparatus discussed above further comprising a gear box comprising gears to provide a gear reduction between the valve drive assembly and the reagent selector valve, the gear box coupled between the valve drive assembly and the reagent selector valve, as in Claim 1.
However, Servin teaches a valve arrangement for fluid flow control wherein a valve drive motor 42 is provided to actuate a rotor 31 cooperating with a stator 30, the rotor and stator forming a shear/rotary valve actuated by the motor. Therein, the rotational drive force from the motor 42 is transferred to the rotor 31 through a drive assembly 32 comprising planetary gear system 44 (Interpreted as a gear box given the broad definition of “gear box” as “a set of gears with a casing” (Oxford Languages), not necessarily requiring the casing to be a box shape.). Therein, the gear box is provided between the motor and the shear/rotary valve assembly (See Fig. 3 and [col. 7, line 53] and [col. 7, line 57].). This arrangement allows for a greater torque to be applied through the motor (via a gear reduction) as enhanced by the gear system, thereby allowing for the use of lower-torque motors and reducing the cost associated with providing high torque motors for fabricating the apparatus (col. 7, line 65). Further, the valve assembly of Servin provides an arrangement capable of controlling multiple fluid pathways with a single motor system (col. 4, line 15) as opposed to conventional solenoids capable of controlling only a single valve and flow (col. 1, line 44).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews to further include a gear box comprising gears to provide a gear reduction between the valve drive assembly and the reagent selector valve, the gear box coupled between the valve drive assembly and the reagent selector valve, such as suggested by Servin, so as to allow for the use of less expensive, lower-torque motors, thereby reducing the manufacturing cost of the apparatus, and to allow for the control of multiple flow paths with a single valve assembly, thereby reducing device complexity and minimizing points of failure, as would be readily recognized by one skilled in the art.
Further, Servin does not specifically teach the valve assembly discussed above adapted to reduce vibrations affecting the flow cell assembly, as in Claim 1. However, given the commensurate arrangement of a gear box separating a driver and a valve assembly, one skilled in the art would expect this arrangement to commensurately provide the advantages of vibrational isolation given the dampening structure of the gear box separating the vibration-producing driver from the valve assembly. Thus, while the prior art does not explicitly list the exact benefit of vibrational isolation claimed by the applicant, the disclosed structure inherently possesses the necessary characteristics to achieve these results. Therefore, the claimed benefits are considered an inherent result of the prior art's structure and are not patentably distinguishing features.
Further, regarding “wherein a longitudinal axis of the valve drive assembly is offset relative to a longitudinal axis of the reagent selector valve to allow the flow cell assembly to be coupled to the flow cell interface without the valve drive assembly obstructing the coupling” mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one skilled in the art would find it obvious to optimize through routine engineering the orientations of the drive assembly and selector valve so as to avoid obstruction to the coupling of the flow cell assembly to the flow cell interface in Drews as such an obstruction would be a predictable issue rendering the device inoperable by preventing fluid flow to the flow cell.
Further to the above, Liang teaches a respective motorized valve structure wherein a stepper motor 17 is offset from the valve assembly and coupled thereto by a belt 4 (Fig. 1 and “The 36-way rotary valve and a stepping motor 17 equipped with a first synchronous pulley 15 are jointly arranged on the common substrate 7 and connected by a belt 4”). Therein, Liang teaches the advantages of this arrangement as providing a compact structure (Abstract), a common consideration in the art relating to in-line motor structures in a valve assembly.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the motor-driven valve assembly of Servin to Drews wherein longitudinal axis of the valve drive assembly is offset relative to a longitudinal axis of the reagent selector valve to allow the flow cell assembly to be coupled to the flow cell interface without the valve drive assembly obstructing the coupling, such as suggested by Liang, so as to provide a compact structure and reduce the device footprint for saving space.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Drews teaches the apparatus discussed above wherein the manifold assembly comprises the valve drive assembly, which is operably coupled to the reagent selector valve 66 (Fig. 2 and [0046]: “…the control system 46 employs one or more valve interfaces 84 which are configured to provide command signals for the valves…” – Thus, the valve drive assembly is operably connected to the reagent selector valve. – See also [0050], as the valves are controlled electronically, the valve drive assembly must be operably connected to the valves to cause such actuation. Thus, the manifold assembly comprises such driving means.), as in Claim 4.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Drews teaches the apparatus discussed above wherein:
the manifold assembly comprises a flow cell valve 68 coupled between the reagent selector valve 66 and the flow cell assembly 20 (Fig. 2 and [0042]: “Selected reagents are then advanced to a common line selector valve 68, which similarly includes a motor (not shown).”),
wherein the flow cell assembly 20 comprises a flow cell having a plurality of channels 56A/56B ([0042]: “…the flow cell 20 includes a series of pathways or lanes 56A and 56B…” – Further note, as discussed above regarding Claim 1, the flow cell assembly is not a positively claimed element herein and is merely an intended workpiece of the flow cell receptacle.),
wherein the flow cell valve 68 is adapted to selectively flow reagent to the plurality of channels 56A/56B (Fig. 2 and [0042]: “The common line selector valve 68 may be commanded to select one or more of the common lines 58 and 60, or both common lines, to cause the reagents 64 to flow to the lanes 56A and/or 56B in a controlled fashion…” – Further note, as discussed above regarding Claim 1, the flow cell assembly is not a positively claimed element herein and is merely an intended workpiece of the flow cell receptacle. Thus, no channels are actually positively provided through the flow cell assembly for flowing reagent.),
as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 6 as discussed above. Further, Drews teaches the apparatus discussed above wherein the flow cell valve 68 comprises a plurality of outlet ports adapted to be coupled to corresponding channels of the flow cell (Fig. 2 shows the flow cell valve 68 as connected to the fluidic lines 58 and 60, thus there must necessarily exist outlet ports of the flow cell valve 68 connected to these fluidic lines 58 and 60 which are fluidically connected to corresponding channels of the flow cell assembly 20.), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 6 as discussed above. Further, Drews teaches the apparatus discussed above wherein the flow cell valve and the reagent selector valve have opposing surfaces (Fig. 2 shows the flow cell valve 68 and the reagent selector valve 66 as having opposing surfaces.),
the valve drive assembly adapted to interface with the flow cell valve 68 and the reagent selector valve 66 at the opposing surfaces to control a position of the flow cell valve and the reagent selector valve (Fig. 2 and [0046]: “…the control system 46 employs one or more valve interfaces 84 which are configured to provide command signals for the valves…”), as in Claim 8.
Regarding Claim 12, the prior art meets the limitations of Claim 6 as discussed above. Further, Drews teaches the apparatus discussed above wherein the reagent selector valve comprises a reagent valve body (the particular valve body structure of the reagent selector valve), the reagent valve body comprising a flow cell interface (The outlet ports of the reagent selection valve 66.) coupled to the flow cell assembly (Fig. 2 shows the flow cell 20 as fluidically coupled to the outlet of the reagent selection valve 66.), as in Claim 12.
Regarding Claim 31, the prior art meets the limitations of Claim 1 as discussed above. Further, Drews teaches the apparatus discussed above wherein the reagent selector valve comprises the flow cell interface (Fig. 2: The side surface of the reagent selection valve opening to the flow cell fluidic line connecting to the common line selection valve for fluidically interfacing with the flow cell.), as in Claim 31.
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Kato, Servin, and Liang, as applied to Claims 1, 4, 6-8, 12, and 31 above, and in further view of Hochgraeber et al. (US 2017/0284980 A1), referred to hereinafter as “Hochgraeber”.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Drews/Kato/Servin/Liang does not specifically teach the apparatus discussed above wherein the reagent selector valve comprises at least one of a ceramic rotor or a ceramic stator, as in Claim 3.
However, Hochgraeber teaches a high-pressure valve wherein the stator consists of ceramic and further describes the benefit of this material as able to resist wear and maintain stability in the high-pressure environment of the valve ([0055]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews/Kato/Servin/Liang to fabricate the stator of the reagent selector valve of ceramic, such as suggested by Hochgraeber, so as to provide wear-resistance and stability of the valve.
Regarding Claim 9, the prior art meets the limitations of Claim 6 as discussed above. Further, Drews teaches the apparatus discussed above wherein the flow cell valve body has a common fluidic line and a plurality of flow cell valve fluidic lines 58/60, the common fluidic line coupled to the reagent selector valve 66 (Fig. 2 shows a fluidic line connecting the reagent selector valve 66 to the flow cell valve 68, which further comprises flow cell fluidic lines 58 and 60 connecting to the flow cell 20.), as in Claim 9.
Further regarding Claim 9, Drews/Kato/Servin/Liang does not specifically teach the apparatus discussed above wherein the flow cell valve comprises a flow cell valve body having a flow cell valve stator and a flow cell valve rotor and wherein the flow cell valve rotor interfaces with the flow cell valve stator to fluidically couple the common fluidic line and one or more of the flow cell valve fluidic lines, as in Claim 9.
However, Hochgraeber teaches a high-pressure valve having a valve rotor 106 and a valve stator 112 (Fig. 3 and [0047]: “The rotor 106 of the switching valve 100, in the rotor end face 110 of which one or a plurality of grooves 108 are provided, interacts with a stator 112 which has a stator end face 114…”) wherein the rotor fluidically interfaces with the stator to fluidically connect any of six input and output ports 118 (Fig. 3).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews/Kato/Servin /Liang to include a switching valve comprising a rotor and stator capable of fluidically interfacing a common input line with multiple output lines, such as suggested by Hochgraeber, so as to provide a sufficient structure to satisfy the need for switching between multiple output lines as is similarly contemplated by Drews.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Kato, Servin, and Liang, as applied to Claims 1, 4, 6-8, 12, and 31 above, and in further view of Dority et al. (US 2017/0021356 A1), referred to hereinafter as “Dority”, and as evidenced through Murray et al. (A. Murray, P. Kettle and F. Moynihan, "Advances in brushless motor control," Proceedings of the 1997 American Control Conference (Cat. No.97CH36041), Albuquerque, NM, USA, 1997, pp. 3985-3989 vol.6), referred to hereinafter as “Murray”.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Drews/Kato/Servin/Liang does not specifically teach the apparatus discussed above wherein the valve drive assembly comprises a brushless motor, as in Claim 5.
However, Dority teaches a fluid handling and diagnostic system wherein a brushless DC (BLDC) motor receives electronic commands to drive a switching valve to a particular position ([0024]). Further, brushless motors are well known for having many advantages over brushed motors, such as improved efficiency, longer lifespan, higher power and torque, and improved safety due to the reduced likelihood of producing a spark, as evidenced through Murray (1. Introduction).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews/Kato/Servin /Liang to include a valve drive assembly utilizing a brushless motor, such as suggested by Murray, so as to achieve improved efficiency, longer lifespan, higher power and torque, and improved safety.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Kato, Servin, Liang, and Hochgraeber, as applied to Claims 3 and 9 above, and in further view of Hollinger et al. (US PAT 5,437,200 A), referred to hereinafter as “Hollinger”.
Regarding Claim 10, the prior art meets the limitations of Claim 9 as discussed above. Further, Drews/Kato/Servin/Liang/Hochgraeber does not specifically teach the apparatus discussed above wherein the flow cell valve rotor comprises a radial groove adapted to fluidically couple the common fluidic line and the one or more of the flow cell valve fluidic lines, as in Claim 10.
However, Hollinger teaches a fluid handling system comprising a valve element 36 wherein the valve disc/rotor comprises a radial groove 78 adapted to complete a catch channel 7g and allow liquid to travel through the resulting channel (Fig. 2 and col. 9, line 30).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews/Kato/Servin/Liang/Hochgraeber to include a valve disc/rotor comprising a radial groove, such as suggested by Hollinger, so as to provide a suitable valve assembly for opening/closing the channels of Drews.
Regarding Claim 11, the prior art meets the limitations of Claim 10 as discussed above. Further, Drews/Kato/Servin/Liang/Hochgraeber does not specifically teach the apparatus discussed above wherein the flow cell valve rotor comprises an arc-shaped groove coupled to a distal end of the radial groove and adapted to allow the common fluidic line to be fluidically coupled to more than one of the flow cell valve fluidic lines, as in Claim 11.
However, Hollinger teaches a fluid handling system comprising a valve element 36 wherein the valve disc/rotor comprises arc-shaped grooves 76’ and 76’’ coupled to a distal end of the radial groove 78 to allow coupling to multiple fluidic lines SI, SL, and/or W (Fig. 2 and col. 9, line 30).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews/Kato/Servin/Liang/Hochgraeber to include a valve assembly comprising an arc-shaped groove coupled to a distal end of the radial groove, such as suggested by Hollinger, so as to provide a suitable structure for fluidically coupling multiple fluidic lines, as is similarly contemplated by Drews.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Hochgraeber, Dority, and Kobayashi et al. (US PAT 4,479,116 A), hereinafter “Kobayashi”, and as evidenced through Murray.
Regarding Claim 16, Drews teaches an apparatus, comprising:
and a system including a manifold assembly and a flow cell receptacle 22 adapted to carry a flow cell assembly 20 ([0036]: “…the flow cell 20 is mounted on a movable stage 22…” -- Fig. 2 and [0005]: “…one or more effluent flow paths to fluidically connect with a flow cell through which a plurality of reagents is to be pumped…”);
the manifold assembly comprising:
a reagent selector valve 66 to be disposed immediately adjacent to the flow cell assembly 20 (Fig. 2 – Examiner further notes Applicant’s amendment reciting “to be disposed” triggers functional language claim interpretation wherein the reagent selector valve is thereby merely required to be capable of being disposed immediately adjacent to the flow cell assembly.), the reagent selector valve 66 comprising a flow cell interface comprising a surface, the surface of the flow cell interface defining an opening of a flow cell fluidic line (The surface of the valve assembly 66 having the fluidic line protruding therefrom to the common line valve, and further to the flow cell.) adapted to selectively flow reagent to the flow cell assembly 20 (Fig. 2 and [0042]: “A reagent selector valve 66 is mechanically coupled to a motor or actuator (not shown) to allow selection of one or more of the reagents to be introduced into the flow cell.”),
and a valve drive assembly operably coupled to the reagent selector valve 66 (Fig. 2 and [0046]: “…the control system 46 employs one or more valve interfaces 84 which are configured to provide command signals for the valves…”),
as in Claim 16.
Further regarding Claim 16, Drews does not specifically teach the apparatus discussed above wherein the manifold assembly is positioned within the flow cell receptacle, as in Claim 16.
However, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Therein, one skilled in the art would find it obvious that the device having the claimed relative arrangement of separate manifold assembly and flow cell receptacle would not perform differently than the prior art device given the manifold and flow cell assemblies perform the identical function regardless of their relative positioning, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the manifold assembly being within the flow cell assembly.
Further regarding Claim 16, Drews does not specifically teach the apparatus discussed above wherein the reagent selector valve comprises a surface to be directly mechanically coupled to a portion of the flow cell assembly, as in Claim 16.
However, merely making integral as one piece what exists in the prior art as separate pieces absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04 (V)(B).
Thus, the claimed integral (directly mechanically coupled) reagent selector valve and flow cell assembly would have been an obvious matter of design choice to one of ordinary skill in the art and does not confer patentability over the separate selector valve and flow cell assembly of Drews. Both the instant reagent selector valve and that taught by Drews commonly serve to select a reagent to deliver to a flow cell wherein its function is not impacted by its position within the device nor mechanical attachment to other structures of the device.
Examiner further notes that Applicant’s amendment reciting “is to be” signals functional language and intended use of the surface. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the surface of Drews is fully capable of being directly mechanically coupled to a portion of the flow cell assembly, absent evidence to the contrary.
Further regarding Claim 16, Drews does not specifically teach the apparatus discussed above wherein the reagent selector valve comprises at least one of a ceramic rotor or a ceramic stator, as in Claim 16.
However, Hochgraeber teaches a high-pressure valve wherein the stator consists of ceramic and further describes the benefit of this material as able to resist wear and maintain stability in the high-pressure environment of the valve ([0055]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews to fabricate the stator of the reagent selector valve of ceramic, such as suggested by Hochgraeber, so as to provide wear-resistance and stability of the valve.
Further regarding Claim 16, Drews does not specifically teach the apparatus discussed above wherein the valve drive assembly comprises a brushless motor, as in Claim 16.
However, Dority teaches a fluid handling and diagnostic system wherein a brushless DC (BLDC) motor receives electronic commands to drive a switching valve to a particular position ([0024]). Further, brushless motors are well known for having many advantages over brushed motors, such as improved efficiency, longer lifespan, higher power and torque, and improved safety due to the reduced likelihood of producing a spark, as evidenced through Murray (1. Introduction).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews to include a valve drive assembly utilizing a brushless motor, such as suggested by Murray, so as to achieve improved efficiency, longer lifespan, higher power and torque, and improved safety.
Further regarding Claim 16, Drews does not specifically teach the apparatus discussed above further comprising a vibration isolation assembly, the vibration isolation assembly comprising a housing coupled to the reagent selector valve and the valve drive assembly, as in Claim 16.
However, Kobayashi teaches a fluid handling system wherein a valve 18 is contained within a housing unit 16 connected to the system via vibration damping hoses 22 (col. 2, line 42).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews/Kato/Hollinger to include a vibration isolation mechanism comprising a housing coupled to the reagent selector valve and the valve drive assembly, such as suggested by Kobayashi so as to provide a suitable structure for achieving the benefits of vibration isolation discussed above.
Regarding Claim 17, the prior art meets the limitations of Claim 16 as discussed above. Further, Drews does not specifically teach the apparatus discussed above wherein the reagent selector valve of the manifold assembly is disposed within the flow cell receptacle, as in Claim 17.
However, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). The device having the claimed relative arrangement of parts would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of said reagent selector valve. Both the claimed reagent selector valve and the reagent selector valve of Drews commonly select and provide reagents to a flow cell and serve the common function of selecting reagents to deliver to the flow cell.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Hochgraeber, Dority, and Kobayashi, as applied to Claims 16-17 above, and in further view of Chu et al. (US PAT 5,726,512 A), referred to hereinafter as “Chu”.
Regarding Claim 21, the prior art meets the limitations of Claim 16 as discussed above. Further, Drews/Hochgraeber/Dority/Kobayashi does not specifically teach the apparatus discussed above wherein the vibration isolation assembly comprises a magnet and is adapted to magnetically levitate the manifold assembly, as in Claim 21.
However, Chu teaches a vibration-free magnetically levitated platform for isolating equipment from vibrations (col. 1, line 15).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews/Hochgraeber/Dority/Kobayashi to include a magnetically levitating shock-absorbing platform, such as suggested by Chu, so as to provide a suitable structure for achieving the benefits of vibration isolation discussed above.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Hochgraeber, Dority, and Kobayashi, as applied to Claims 16-17 above, and in further view of Maimon et al. (US PAT 7,478,710 B2), hereinafter “Maimon”.
Regarding Claim 22, the prior art meets the limitations of Claim 16 as discussed above. Further, Drews/Hochgraeber/Dority/Kobayashi does not specifically teach the apparatus discussed above wherein the vibration isolation assembly comprises a shock absorber, as in Claim 22.
However, Maimon teaches a respective apparatus comprising a pump contained within a housing, the housing comprising a base (the upper plate as seen through Fig.1) and a support (Fig. 1: the pump housing 1A), wherein the support is coupled to the base by shock absorbers/dampeners 3A. Therein, the support comprises a first portion (the interior surface of the support) and a second portion (the exterior surface of the support) wherein the vibration-causing pump is contained within the first portion. Therein, this arrangement reduces vibrational translation of vibrations caused by the pump to other vibration-sensitive elements of the device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews/Hochgraeber/Dority/Kobayashi to include a shock absorber, such as suggested by Maimon, so as to provide a suitable structure for achieving the benefits of vibration isolation discussed above.
Regarding Claim 23, the prior art meets the limitations of Claim 16 as discussed above. Further, Drews/Hochgraeber/Dority/Kobayashi does not specifically teach the apparatus discussed above further comprising shock absorbers, wherein the housing of the vibration isolation assembly comprises a base and a support, the support is coupled to the base by the shock absorbers, the support comprises a first support portion and a second support portion, the first support portion carries the valve drive assembly, as in Claim 23.
However, Maimon teaches a respective apparatus comprising a vibration-causing pump contained within a housing, the housing comprising a base (the upper plate as seen through Fig.1) and a support (Fig. 1: the pump housing 1A), wherein the support is coupled to the base by shock absorbers/dampeners 3A. Therein, the support comprises a first portion (the interior surface of the support) and a second portion (the exterior surface of the support) wherein the vibration-causing pump is contained within the first portion. Therein, this arrangement reduces vibrational translation of vibrations caused by the pump to other vibration-sensitive elements of the device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews/Hochgraeber/Dority/Kobayashi to further include shock absorbers, wherein the housing of the vibration isolation assembly comprises a base and a support, the support is coupled to the base by the shock absorbers, the support comprises a first support portion and a second support portion, the first support portion carries the valve drive assembly, such as suggested by Maimon, so as to reduce vibrational translation of vibrations caused by the valve driver to other vibration-sensitive areas of the device, as would be easily recognized by one skilled in the art in an analytical fluidic device such as Drews where optical measurements may be affected by vibrations.
Claims 24 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Hochgraeber, Dority, Kobayashi, and Maimon, as applied to Claims 22-23 above, and in further view of Servin. Servin has been discussed above.
Regarding Claim 24, the prior art meets the limitations of Claim 23 as discussed above. Further, Drews/Hochgraeber/Dority/Kobayashi/Maimon does not specifically teach the apparatus discussed above further comprising a gear box comprising gears to provide a gear reduction between the valve drive assembly and the reagent selector valve, the gear box coupled between the valve drive assembly and the reagent selector valve, as in Claim 24.
However, Servin teaches a valve arrangement for fluid flow control wherein a valve drive motor 42 is provided to actuate a rotor 31 cooperating with a stator 30, the rotor and stator forming a shear/rotary valve thereby actuated by the motor. Therein, the rotational drive force from the motor 42 is transferred to the rotor 31 through a drive assembly 32 comprising planetary gear system 44 (Interpreted as a gear box given the definition of “gear box” as “a set of gears with its casing” (Oxford Languages).). Therein, the gear box is provided between the motor and the shear/rotary valve assembly (See Fig. 3 and [col. 7, line 53] and [col. 7, line 57].). Therein, this arrangement allows for a greater torque to be applied through the motor (via a gear reduction) as enhanced by the gear system, thereby allowing for the use of lower-torque motors and reducing the cost associated with providing high torque motors (col. 7, line 65). Further, the valve assembly of Servin provides an arrangement capable of controlling multiple fluid pathways with a single motor system (col. 4, line 15) as opposed to conventional solenoids capable of controlling only a single valve and flow (col. 1, line 44).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews to further include a gear box comprising gears to provide a gear reduction between the valve drive assembly and the reagent selector valve, the gear box coupled between the valve drive assembly and the reagent selector valve, such as suggested by Servin, so as to allow for the use of less expensive, lower-torque motors, thereby reducing the manufacturing cost of the apparatus, and to allow for the control of multiple flow paths with a single valve assembly, thereby reducing device complexity and minimizing points of failure, as would be readily recognized by one skilled in the art.
Regarding Claim 26, the prior art meets the limitations of Claim 25 as discussed above. Further, Drews/Hochgraeber/Dority/Kobayashi/Maimon does not specifically teach the apparatus discussed above wherein the second support portion defines a through hole and is positioned between the valve drive assembly and the reagent selector valve, the gear box extends through the through hole of the second support portion, as in Claim 26.
However, Servin teaches the valve system discussed above wherein the gear box extends through a through hole of the device housing 41 positioned between the driver 42 and the selector valve 31 so as to couple the driver and selector valve (Fig. 3), thereby providing a suitable structure for the transfer of torque from the gear box to the rotor, and providing sufficient space within the housing for the gear box.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying the device of Drews/Hochgraeber/Dority/Kobayashi/Maimon with the gear box of Servin, to provide a through hole positioned between the valve drive assembly and the reagent selector valve, the gear box extending through the through hole of the second support portion, such as suggested by Servin, so as to provide a suitable structure for coupling the driver and selector valve.
Regarding Claim 27, the prior art meets the limitations of Claim 26 as discussed above. Further, as discussed above regarding Claim 24, one skilled in the art would find it obvious to modify the apparatus of Drews/Hochgraeber/Dority/Kobayashi/Maimon with the gear box of Servin to achieve amplified torque. Therein, Servin provides said gear box configured to guide rotation of the valve rotor (col. 3, line 14) so as to achieve rotation of the rotor through the gears of the gear box to effect actuation of the valves formed by the rotor.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying the apparatus of Drews/Hochgraeber/Dority/Kobayashi/Maimon with the gear box of Servin, to provide a reagent valve rotor wherein the gear box is configured to guide rotation of the reagent valve rotor, such as suggested by Servin, so as to achieve the sought rotation of the valve rotor in Servin via the gears of the gear box to control flow through the valve.
Regarding Claim 28, the prior art meets the limitations of Claim 27 as discussed above. Further, as discussed above regarding Claim 24, one skilled in the art would find it obvious to modify the apparatus of Drews/Hochgraeber/Dority/Kobayashi/Maimon with the gear box of Servin to achieve amplified torque. Therein, Servin provides said gear box comprising a multi-stage planetary gear box (Fig. 3 shows a two-stage planetary gear system. See further col. 7, line 57) so as to achieve the sought torque amplification for rotation of the valve rotor.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying the apparatus of Drews/Hochgraeber/Dority/Kobayashi/Maimon with the gear box of Servin, to provide said gear box as a multi-stage planetary gear box so as to achieve the sought torque amplification for rotation of the valve rotor in Servin.
Further, Examiner notes that the claim recites mere nominal designations of the gear box, thereby only effectively requiring a box. Applicant may wish to amend the claim to recite “spur gears” and “planetary gears” comprised within the gear box. Further note that gearbox and gear box designate distinct requirements, wherein a gearbox (no space) comprises a set of gears (for example, a vehicle transmission is a gearbox), and a gear box (space between gear and box) comprises a mere box capable of holding gears.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Hochgraeber, Dority, Kobayashi, Maimon, and Servin, as applied to Claims 24 and 26-28 above, and in further view of Liang et al. (CN 101008455 A), hereinafter “Liang”.
Regarding Claim 25, the prior art meets the limitations of Claim 24 as discussed above. Further, Drews/Hochgraeber/Dority/Kobayashi/Maimon/Servin does not specifically teach the apparatus discussed above wherein a longitudinal axis of the valve drive assembly is offset relative to a longitudinal axis of the reagent selector valve to allow the flow cell assembly to be coupled to the flow cell interface without the valve drive assembly obstructing the coupling, as in Claim 25.
However, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one skilled in the art would find it obvious to optimize through routine engineering the orientations of the drive assembly and selector valve so as to avoid obstruction to the coupling of the flow cell assembly to the flow cell interface in Drews as such an obstruction would be a predictable issue which would render the device inoperable by preventing fluid flow to the flow cell.
Further to the above, Liang teaches a respective motorized valve structure wherein a stepper motor 17 is offset from the valve assembly and coupled thereto by a belt 4 (Fig. 1 and “The 36-way rotary valve and a stepping motor 17 equipped with a first synchronous pulley 15 are jointly arranged on the common substrate 7 and connected by a belt 4”). Therein, Liang teaches the advantages of this arrangement as providing a compact structure (Abstract), a common consideration in the art relating to in-line motor structures in a valve assembly.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the motor-driven valve assembly of Servin to Drews wherein longitudinal axis of the valve drive assembly is offset relative to a longitudinal axis of the reagent selector valve to allow the flow cell assembly to be coupled to the flow cell interface without the valve drive assembly obstructing the coupling, such as suggested by Liang, so as to provide a compact structure and reduce the device footprint for saving space.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Hochgraeber, Dority, Kobayashi, Maimon, and Servin, as applied to Claims 24-28 above, and in further view of Amini et al. (US 2019/0203287 A1), hereinafter “Amini”, and Roos et al. (US 2003/0022388 A1), hereinafter “Roos”.
Regarding Claim 29, the prior art meets the limitations of Claim 28 as discussed above. Further, Drews teaches the apparatus discussed above further comprising a pump ([0005]: “one or more pumps”), wherein the reagent selector valve is adapted to selectively flow the reagent toward a first end of the flow cell assembly and into the flow cell assembly in a first direction (Fig. 2 and [0019]), as in Claim 29.
Further regarding Claim 29, Drews/Hochgraeber/Dority/Kobayashi/Maimon /Servin does not specifically teach the apparatus discussed above further comprising a sample loading manifold assembly, and a sample cartridge receptacle adapted to receive a sample cartridge, wherein the sample loading manifold assembly and the pump are adapted to flow one or more samples of interest from the sample cartridge toward a second end of the flow cell assembly and into the flow cell assembly in a second direction, the first direction is opposite the second direction, the first end of the flow cell assembly is opposite the second end of the flow cell assembly, as in Claim 29.
However, Amini teaches a respective flow cell arrangement comprising a cartridge receptacle for receiving a cartridge-style library of nucleic acid samples for analysis of the sample library ([0167]) wherein this arrangement allows for an automated system handling the library as a whole, thereby increasing throughput and reducing the footprint of the library and system handling said library ([0161, 0167]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Drews/Hochgraeber/ Dority/Kobayashi/Maimon/Servin to further include a sample loading manifold assembly, and a sample cartridge receptacle adapted to receive a sample cartridge, such as suggested by Amini, so as to achieve the benefits of increased automation and reduced apparatus footprint.
Further, regarding “the sample loading manifold assembly and the pump are adapted to flow one or more samples of interest from the sample cartridge toward a second end of the flow cell assembly and into the flow cell assembly in a second direction, the first direction is opposite the second direction, the first end of the flow cell assembly is opposite the second end of the flow cell assembly”, Roos teaches a respective flow cell arrangement wherein sample and reagent are introduced to the flow cell from opposite ends of said flow cell to enact rapid contact and mixing of sample and reagent ([0038, 0059-0060]), wherein such rapid mixing is beneficial for time-synchronized analysis of the particles contained within the sample fluid, ensuring the entire sample volume begins interacting with the reagent at a same time.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the apparatus of Drews/Hochgraeber/ Dority/Kobayashi/Maimon/Servin/Amini wherein the sample loading manifold assembly and the pump are adapted to flow one or more samples of interest from the sample cartridge toward a second end of the flow cell assembly and into the flow cell assembly in a second direction, the first direction is opposite the second direction, the first end of the flow cell assembly is opposite the second end of the flow cell assembly, such as suggested by Roos, so as to ensure the entire sample volume begins interacting with the reagent at a same time, thereby reducing errors related to lagging sample volume.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Kato and Servin, as applied to Claims 1, 4, 6-8, 12, and 31 above, and in further view of Gale et al. (Gale, B. K., Jafek, A. R., Lambert, C. J., Goenner, B. L., Moghimifam, H., Nze, U. C., & Kamarapu, S. K. (2018). A Review of Current Methods in Microfluidic Device Fabrication and Future Commercialization Prospects. Inventions, 3(3), 60.), hereinafter “Gale”.
Regarding Claim 30, the prior art meets the limitations of Claim 1 as discussed above. Further, Drews teaches the apparatus discussed above further comprising the flow cell assembly comprising a plurality of channels (Fig. 2: Lanes 56A and 56B), as in Claim 30.
Further, Drews does not specifically teach the apparatus discussed above wherein the flow cell assembly comprises a laminate, the laminate to fluidically couple the plurality of channels and the opening of the flow cell fluidic line, as in Claim 30.
However, Gale teaches the use of laminated structures as prevalently used in the art of flow cells and describes the benefits of such laminated flow cells as offering fabrication through relatively inexpensive materials and instruments, simple process steps, rapid fabrication times, well-controlled layer depths (set by material thickness), optical access, and submillimeter feature sizes for precision flow processes (Section 2. Laminates: paragraph 2).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the flow cell assembly of Drews as a laminate structure so as to achieve the benefits discussed above, wherein the implementation of the laminate in Drews would result in the laminate to fluidically couple the plurality of channels and the opening of the flow cell fluidic line, given the respective orientation of channels and connection of fluidic lines in Drews.
Examiner further notes that as the flow cell is not a positive element of the claim, the recitations to its composition hold no patentable weight. The rejection above is provided as a courtesy given it appears to be Applicant’s intend the flow cell assembly be a positive element, given the prior versions of the claims.
Response to Arguments
Remarks
Applicant states on page 9 of the response submitted 08/26/2025 that the arguments and amendments therein are submitted in response to a non-final office action mailed 06/09/2025. However, it is noted that that action mailed 06/09/2025 was a final rejection, and the instant office action set forth above is in response to Applicant’s request for continued examination and payment of the associated fee.
35 USC 112
Applicant’s amendments sufficiently overcome those rejections of Claims 21 and 23 set forth by the previous office action under 35 USC 112 as improperly dependent for depending on a cancelled claim. Thus, those rejections of Claims 21 and 23 are hereby withdrawn.
35 USC 103
Applicant’s arguments are on the grounds that none of Drews or the additional cited references teach or fairly suggest the gear box required by Claims 1 and 24 as in Applicant’s amendments submitted 08/26/2025.
Applicant’s arguments are not persuasive because the deficiency of a gear box in the previously applied references is cured by the incorporation of the newly cited reference of Servin (as necessitated by Applicant’s amendments), teaching a gear box between a motor and a valve rotor, wherein one skilled in the art would find it obvious to apply said gear box arrangement of Servin to the apparatus of Drews for enhancing the torque applied to the rotor through a gear reduction driven by the motor, thereby allowing for the use of lower-cost, lower-torque motors for driving the selection valves of Drews.
Thus, Examiner respectfully sets forth the rejection of Claims 1 and 24, and dependent claims thereof, as unpatentable under 35 USC 103 over at least Drews in view of Servin, as discussed above in the body of the action.
Applicant appears to further argue the instant reagent selector valve being recited as having a surface to be directly mechanically coupled to the flow cell assembly. However, as discussed above in the body of the action, Applicant’s amendments render the claims as no longer positively requiring the flow cell assembly, instead reciting it by way of functionality of the flow cell receptacle as an intended workpiece. Further, Applicant’s language reciting the surface “to be coupled” is interpreted as functional language merely requiring a surface of the reagent selector valve as being capable of mechanical coupling to the flow cell assembly. Therein, that surface in Drews is fully capable of such a direct mechanical coupling, absent evidence to the contrary.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798