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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 28 April 2026.
Claims 1, 3-5, 16, and 21-36 are pending.
Claims 2, 6-15, and 17-20 are cancelled.
No claims are withdrawn.
Claims 32-36 are newly added.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior 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 direct current (DC) motor, a stepper motor,... a strain wave gear servo drive,... a piezoelectric motor...” as in para. [0065] of Applicant’s instant specification filed 06/29/2022...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
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, 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 comprising a reagent selector valve body (an outer valve layer providing the flow path of any valve) and 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 comprising a side of the reagent selector valve body, the flow cell interface comprising a surface of the side of the reagent selector valve body, the 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 comprising 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 comprising the side of the reagent selector valve body 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 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.
Claim 3 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, 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.
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, 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.
Claim 16 is 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 comprising a body (an outer valve layer providing the flow path of any valve) and 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 of a side of the reagent selector valve body, the surface of the side of the reagent selector valve body comprising 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.
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 Claim 16 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 further 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 Claim 16 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 further 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, 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.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Hochgraeber, Dority, Kobayashi, Maimon, Servin, Amini, and Roos, as applied to Claim 29 above, and in further view of Guo et al. (WO 2020/118255 A1), hereinafter “Guo”.
Regarding Claim 32, the prior art meets the limitations of Claim 29 as discussed above. Further, Drews teaches the apparatus discussed above wherein the reagent cartridge receptacle is positioned upstream of the flow cell receptacle to enable the reagent to flow toward the first end of the flow cell assembly and into the flow cell assembly in the first direction (See Fig. 2 as showing the vessel recipients 64 ([0042]) as upstream of the flow cell 20, as indicated by the direction of the pointed arrows of the fluidic lines 58 and 60.), as in Claim 32.
Further as in Claim 32, Drews does not specifically teach the apparatus discussed above wherein the sample loading manifold assembly and the sample cartridge receptacle are each positioned downstream of the flow cell receptacle to enable the one or more samples of interest from the sample cartridge to flow toward the second end of the flow cell assembly and into the flow cell assembly in the second direction, as in Claim 32.
However, Guo teaches a respective flow cell assembly (abstract) wherein said flow cell (as shown in Figs. 1 and 4), is operable to receive both forward and reverse flow ([0188]: “In some instances, different modes of fluid flow control are utilized at different points in an assay or analysis procedure, e.g. forward flow (relative to the inlet and outlet for a given capillary flow cell device), reverse flow, oscillating or pulsatile flow, or combinations thereof.”) depending on the requirements of a particular assay being performed by the device. Therein, one of ordinary skill in the art would recognize that, in a reverse flow arrangement, if particular samples or reagents are to be injected, as is typically performed at the various steps of sequencing by synthesis assays (as focused upon by Guo), that an upstream injection port (or cartridge receptacle) relative to the reverse flow direction is necessary.
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 device of Drews/Hochgraeber/ Dority/Kobayashi/Maimon/Servin/Amini/Roos wherein the sample loading manifold assembly and the sample cartridge receptacle are each positioned downstream of the flow cell receptacle to enable the one or more samples of interest from the sample cartridge to flow toward the second end of the flow cell assembly and into the flow cell assembly in the second direction, such as suggested by Guo, so as to enable sample/reagent additions when the device is operated in a reverse flow direction as discussed by Guo, thereby allowing for more complex assays to be performed by the device.
Further as in Claim 32, the terms “upstream” and “downstream” are relative terms which are based in process-type requirements of the device which are different depending on how the device is operated, i.e., the flow direction applied to the device. The terms “upstream” and “downstream” as in Claim 32 are given their broadest reasonable interpretation as merely referring to opposite ends of the flow cell.
Claims 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Drews in view of Hochgraeber, Dority, Kobayashi, Maimon, Servin, Amini, Roos, and Guo, as applied to Claim 32 above, and in further view of Yamamoto (US 2006/0119935 A1), hereinafter “Yamamoto”.
Regarding Claim 33, the prior art meets the limitations of Claim 32 as discussed above. Further, Drews/Dority/Kobayashi/Maimon/Servin/Amini/Roos/Guo do not specifically teach the apparatus discussed above wherein the shock absorbers comprise gel isolators, as in Claim 33.
However, Yamamoto teaches a fluorescence microscope system wherein gel vibration damping members 85 are mounted within the device so as to dampen vibrations from a fan unit 38 from reaching the fluorescence stage. Further, while Yamamoto does not necessarily specifically discuss flow cells, one skilled in the art would recognize the device of Drews as employing fluorescence microscopy ([0036]) for sequencing operations and look at other fluorescence microscopy systems for solutions to vibrations affecting the flow cell.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify eh device of Drews/Dority/Kobayashi/Maimon/Servin/Amini/Roos/Guo wherein the shock absorbers comprise gel isolators, such as suggested by Yamamoto, as a mere obvious alternative/specific option for the shock absorbers so as to achieve vibration dampening, and wherein one skilled in the art would recognize this need in Drews given its commensurate of fluorescence microscopy as in Yamamoto.
Regarding Claim 34, the prior art meets the limitations of Claim 33 as discussed above. Further, Drews does not specifically teach the apparatus wherein the reagent selector valve comprises a reagent selector valve body comprising a reagent valve stator and a reagent valve rotor, as in Claim 34.
However, Servin, as combined with Drews as discussed above regarding Claim 24, 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 wherein grooves and openings correspond to various pathways managed by a singular valve mechanism. Therein, this 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), thereby reducing the number of movable parts and improving the maintenance of and resilience of the device to wear and tear.
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 wherein the reagent selector valve comprises a reagent selector valve body comprising a reagent valve stator and a reagent valve rotor, such as suggested by Servin, thereby reducing the number of movable parts and improving the maintenance of and resilience of the device to wear and tear.
Regarding Claim 35, the prior art meets the limitations of Claim 34 as discussed above. Further, Drews teaches the apparatus discussed above wherein the reagent selector valve body comprises a common fluidic line, a reagent fluidic line, and the flow cell fluidic line, the reagent fluidic line being adapted to be fluidically coupled to the corresponding reagent reservoirs (See Fig. 2 showing three separate fluidic lines emerging from the selector valves 66/68. Therein, these generic lines fully meet the claim requirements as the designation terms “reagent”, “flow cell”, and “common” regarding the fluidic lines are merely nominal in nature, they do not impart any structural distinction over Drews.), as in Claim 35.
Further as in Claim 35, Drews does not teach the reagent fluidic line as being a plurality of reagent fluidic lines, as in Claim 35.
However, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Herein, one of ordinary skill in the art would find it obvious to add additional reagent fluidic lines if additional reagents are needed for a particular assay undertaken by the device of Drews, and/or if specific separation of reagents within the lines is desired for said assay.
Regarding Claim 36, the prior art meets the limitations of Claim 35 as discussed above. Further, Servin does not specifically teach the apparatus discussed above wherein the reagent valve rotor comprises a radial groove adapted to fluidically couple the common fluidic line and the corresponding reagent fluidic line, as in Claim 36.
However, Servin, as combined with Drews as discussed above regarding Claim 24, 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, grooves of the rotor correspond to various pathways managed by the singular valve mechanism which are coupled and decoupled by the grooves of the rotor forming fluidic flow paths through the grooves (col. 1, line 24: “Many rotary valve assemblies are driven by stepper motors which are used for positioning a grooved rotor device to multiple locations on a stator device.”). Therein, this 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), thereby reducing the number of movable parts and improving the maintenance of and resilience of the device to wear and tear.
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 wherein the reagent valve rotor comprises a radial groove adapted to fluidically couple the common fluidic line and the corresponding reagent fluidic line, such as suggested by Servin, so as to provide a suitable valve arrangement for managing multiple flow paths and reagents.
Response to Arguments
35 USC 112(f)
The Claim Interpretation section above in the body of the action has been amended in view of Applicant’s provided section of the instant specification listing different motor-types that may be used, and equivalents thereof.
35 USC 112
Applicant’s amendments sufficiently overcome those rejections over Claims 1, 3-12, and 30-31 set forth by previous official correspondence as indefinite under 35 USC 112(b). As such, those rejections under 35 USC 112(b) are withdrawn herein.
35 USC 103
Applicant’s arguments are on the alleged grounds that Drews does not teach or fairly suggest “a flow cell interface that includes a surface of a side of a reagent selector valve body, where the surface defines an opening of a flow cell fluidic line to selectively flow reagent from a corresponding reagent reservoir to the flow cell assembly”, as in Claim 1, and that such a modification in Drews would render Drews unsatisfactory for its intended purpose.
Applicant’s arguments are not persuasive because Drews teaches or at least fairly suggests the claimed fluidic line arrangement as seen through Drews Fig. 2 showing fluidic lines 58, 60, and 62 emerging from the common line selection valve 68. See further para. [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.” Discussing selective flow of reagents to the flow cell depending on the valve position.
Applicant further argues that certain lines and valves would be omitted when modifying Drews to arrive at the above discussed Claim 1 requirement; however, it is not clear as to why such elements would necessarily need to be completely omitted. The rearrangement of those elements of Drews to fit within such a valve arrangement of the instant claim would represent no more than routine engineering and optimization.
Applicant further argues on the alleged grounds that the prior official correspondence fails to provide fact specific analysis as to why one of ordinary skill in the art would arrive at the claimed manifold assembly positioned within the flow cell receptacle beyond rearrangement of parts case law discussed by MPEP 2144.04(VI)(C).
Applicant’s argument is not persuasive because the prior official correspondence discussed that the apparatus of Drews having its valve manifold outside of a flow cell receptacle would not perform any differently than the claimed invention as the valve manifold is merely moved to a different location (similarity to Japikse and Kuhle). Said valve manifold retains its base function of providing selective reagent switching regardless of its location, and as such, said location is seen as an obvious matter of design choice and/or routine optimization of space up to one of ordinary skill in the art (motivation for rearrangement). Further, the benefits of reduced dead volume, reduced reagent consumption, etc. presented by Applicant would all be readily anticipated and expected by one of ordinary skill in the art who would recognize that shortening tubing reduces dead volume, wherein such reduction of dead volume and optimization of tubing length is a common optimization goal in the fluidic arts.
Applicant further argues on the alleged grounds that the integral/separate design choice rejection (MPEP 2144.04(V)) fails to account for the alleged unexpected results of dead volume, reduced reagent use, etc. presented by Applicant, and that such a modification in Drews would render the apparatus of Drews unsatisfactory for its intended purpose by allegedly necessitating the omission of various valves and fluidic lines.
Applicant’s arguments are not persuasive because, similarly as discussed above, the benefits of reduced dead volume, reduced reagent consumption, etc. presented by Applicant would all be readily anticipated and expected by one of ordinary skill in the art who would recognize that shortening tubing reduces dead volume, wherein such reduction of dead volume and optimization of tubing length is a common optimization goal in the fluidic arts. As such, one of ordinary skill in the art would have found it obvious to directly couple the cited elements of Drews, wherein said elements retain their relative basic functions and do not function any differently than if they were provided as separate elements such as in Drews. Further, similarly as above, it is not clear as to why such elements would necessarily need to be completely omitted. The rearrangement of those elements of Drews to fit within such a directly mechanically coupled valve arrangement of the instant claim would represent no more than routine engineering and optimization.
Applicant further argues that the “directly mechanically coupled” language of Claim 1 does not invoke the integral/separate nature as discussed in MPEP MPEP 2144.04(V) as the coupled elements form an allegedly novel flow cell interface arrangement and does not merely attach two separate components.
Applicant’s arguments are not persuasive because when elements are rigidly fastened, bolted, or directly coupled to function as a single unit, substituting a single, one-piece molded/machined part for the coupled pieces is obvious. Thereby, such rigidly coupled pieces are interpreted as an integral “one piece/single unit” as the pieces are specifically fastened together to act as a whole. Thus, Applicant’s “directly mechanically coupled” represents a mere obvious matter of making integral vs separate. Further, Applicant’s alleged “novel flow cell interface” in as much as is claimed by claim 1 is merely two joined surfaces with fluidic lines running therebetween. Applicant must provide more particular structural detail if a particular interface is desired.
Applicant states that Kato, Servin, and Liang were not used to address the above-mentioned recitations of claim 1 and fail to teach or suggest the same. None of those references are applied for curing any of the above discussed alleged deficiencies of Claim 1 drawn to the arrangement of Drews.
Applicant further argues that Claim 16 is allowable for the same reasons as above. However, as discussed above, Applicant’s arguments are not persuasive. As such, Claim 16 is not allowable for the arguments discussed above.
For the reasons discussed above, Examiner maintains the rejections of Claims 1 and 16, and dependents thereof, under 35 USC 103.
New Claims 32-36
New claims 32-36 are rejected under 35 USC 103 as discussed above in the body of the action. Claims 32 and 33 necessitated the citing of the additional prior art of Guo and Yamamoto respectively herein, as necessitated by the new addition of the claims.
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.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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