Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 1-3 and 7-15 in the reply filed on 06/01/26 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 7-8, 11, 13, and 14 is/are rejected under 35 U.S.C. 102(1)(1) as being anticipated by Khandros (US 20130319861 A1), as evidenced by Wu (US 7612355 B2) and Daridon (US 20140378352 A1).
Regarding claims 1 and 14, Khandro discloses a bioparticle enrichment apparatus (100, Fig. 1) provided for selecting at least one of bioparticles (micro-objects 120, Fig. 1) from a liquid specimen (liquid medium 122, Fig. 1B-c) having the bioparticles, wherein the bioparticle enrichment apparatus is configured to be used with optoelectronic tweezers of Wu (Such devices (not shown) can include electrowetting devices such as optoelectronic wetting (OEW) devices (e.g., as disclosed in U.S. Pat. No. 6,958,132, which is incorporated by reference herein in its entirety). Khandros, para. [0052]); the bioparticle enrichment apparatus comprising:
a pico-droplet generator including:
a light sensing structure (base 102, Fig. 1-4, Khandros; bottom layer 18, Fig. 1, Wu) including:
a first substrate (n + a-Si:H 22, Fig. 1, Wu; said base comprises a first substrate, claim 25);
a first electrode layer (ITO-coated glass/ITO Electrode 20, Fig. 1 and 36, Wu) and a photoelectric layer (photosensitive surface/photoconductor 24, Fig. 1 and 36, Wu) respectively formed on two opposite sides of the first substrate (22 and 24 are disposed on opposite side of 22 in Fig. 1); and
an insulating layer (silicon nitride 26, Fig. 1, Wu) covering the photoelectric layer (26 disposed on top of 24 in Fig. 1);
a mating structure (thin dielectric layer 16, Fig. 1, Wu; processing mechanism 110, Fig. 1, Khandros) spaced apart from the light sensing structure (spaced apart by liquid medium 122 in Fig. 1 of Khandros and liquid layer 12 of Fig. 1 of Wu), wherein at least one of the mating structure and the light sensing structure is transparent (Wu discloses 16 and/or 20 are transparent in Col. 16, lines 62-63 and Col. 36, lines 14-16 respectively; The upper electrode 402 and/or wall 404 can be transparent. Fig. 4 and para. [0064]), and the mating structure includes a second substrate that faces toward the light sensing structure (thin dielectric layer/ITO glass 16, Fig. 5, Wu) and a second electrode layer (thin Al (aluminum) 48, Fig. 5, Wu) that is formed on the second substrate;
a bonding layer (layer formed by spacers 42 and 44, Fig. 5, Wu; layers formed by vertical spacers annotated by arrow 108 and 124 that connects the processing mechanism 110 to base 102 in Fig. 1, Khandros) that is connected in-between the light sensing structure and the mating structure along a thickness direction (z direction; vertical direction) so as to jointly define a selection channel (chamber 410, Fig. 4, Khandros; liquid layer 12, Fig. 5, Wu) along a flowing direction (y direction) perpendicular to the thickness direction (direction of the flow), wherein at least one of the mating structure and the bonding layer has an inlet (108, Fig. 1, Khandros) that is located at an upstream of the selection channel and an outlet (124, Fig. 1, Khandros) that is located at a downstream of the selection channel, and wherein the bonding layer has a selection hole (output passage 116, Fig. 1B-C, Khandros) that is in spatial communication with the selection channel along a dripping direction perpendicular to the thickness direction and the flowing direction; and
a piezoelectric member (Khandros disclose outputting mechanism is striking mechanism, para. [0073]; For example, the actuator 902 can comprise a piezoelectric material (e.g., a piezoelectric element or stack comprising lead zirconate titanate (PZT), piezocrystal, piezopolymer, or the like) that expands, as shown in FIG. 2, in response to a change in a voltage applied to the piezoelectric material. Para. [0079]) disposed on the bonding layer (outputting mechanism 114, Fig. 1 and actuator 902, Fig. 8, Khandros; disposed on does not require direct mating), wherein the piezoelectric member and the selection hole are respectively located at two opposite sides of the bonding layer along the dripping direction (Fig. 3A-B, Khandros), and wherein the pico-droplet generator has a pico-droplet emission region defined as extending from the selection hole toward the piezoelectric member (See Fig. 3B, the part of outer passage 116 extending from the lower surface 106 to upper surface 104);
a power device electrically coupled to the first electrode layer and the second electrode layer (biasing voltage 412, Fig. 4, para. [0063], Khandros; Biasing source 16, Fig. 1, Col. 13, Lines 7-8, Wu);
a pressure balance device including a first valve that is assembled to the inlet and a second valve that is assembled to the outlet, wherein the pressure balance device is configured to control a velocity and a pressure of the liquid specimen in the selection channel through the first valve and the second valve (An inlet 108 can be, for example… a valve, or the like. The processing mechanism 110 can also include one or more outlets 124 through which the medium 122 with or without micro-objects 120 can be removed from the processing mechanism 110. An outlet 124 can be, for example…a valve, or the like. Para. [0053], Khandros);
a camera device (imaging device 420 (e.g., a camera or other vision device), Fig. 4, Khandros) corresponding in position to a viewable segment of the selection channel (light pattern 418, Fig. 4, Khandros), wherein the pico-droplet emission region is arranged in the viewable segment (As shown, more than one of the micro-objects 120′ in the medium 122 can be selected by projecting a light pattern in the form of a light cage 602 onto the photoconductive layer 408 around the selected micro-objects 120′. The light cage 602 can then be moved on the photoconductive layer 408 into the outputting mechanism 114 (not shown in FIG. 6). Para. [0068], Khandros), and the camera device is configured to take a real-time image of the liquid specimen in the viewable segment; and
a control device (sensor 206, Fig. 2, Khandros) electrically coupled to the piezoelectric member (in some embodiments, a sensor 206 can detect a position of a micro-object (e.g., micro-object 120′ in FIG. 2) in the channel 202. A signal from the sensor 206 can be used to automatically trigger the outputting mechanism 114, para. [0057], Khandros), wherein, when the real-time image obtained by the camera device shows that at least one of the bioparticles is located in the pico-droplet emission region (para. [0064], Khandros), the control device allows the piezoelectric member to output a pico-droplet (droplet 126, Fig. 1, Khandros) by driving the liquid specimen in the pico-droplet emission region to pass through the selection hole, and wherein the pico-droplet covers the at least one of the bioparticles (the outputting mechanism 114 can be configured to output (e.g., express) a droplet 126 of the medium 122 containing one or more of the micro-object(s) 120′ through the output passage 116 in the base 102. para. [0052], Fig. 1B-C, Khandros).
Regarding claims 2-3, Khandros and Wu disclose the claimed embodiment as discussed above in claim 1. Khandros discloses the bioparticles located in the viewable segment have at least one target and non-target bioparticle (120 and 120’, Fig. 5; Note this part of claim limitation is interpreted to be intended use), and the bioparticle enrichment apparatus further includes a light source mechanism (OET 400, Fig. 4-6, Such devices (not shown) can include devices for creating dielectrophoresis (DEP) forces on selected ones of the micro-objects 120 to select and/or move the micro-objects 120. Para. [0052]) that is configured to move the at least one target bioparticle into the pico-droplet emission region/at least one non-target bioparticle away from the pico-droplet emission region by emitting light onto the at least one target/non-target bio particle to apply a DEP force to the at least one target/non-target bioparticle through the light sensing structure A “virtual electrode” that attracts/repels a micro-object 120 can thus be created at any area or areas on the photoconductive material by illuminating the area or areas. Para. [0063]).
For similar reason, the rationale and mapping above also teaches the claimed invention of claim 13.
Regarding claim 7, Khandros and Wu disclose the claimed invention as discussed above in claim 2. The claim is interpreted to be an intended use limitation. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Moreover, Khandros discloses the inlet and outlet comprises two valves configured to be opened and shut. Even though the specific mode of operation is not explicitly stated, keeping a valve open to receive continuous inflow of fluid while closing another valve to redirect the fluid to a different channel/outlet is a well-known operation. Evidential reference Daridon discloses leaving some valves open and other valves close to redirect flow away from closed channels (para. [0435]-[0437]).
Regarding claim 8, Khandros and Wu disclose the claimed embodiment as discussed above in claim 1. Khandros discloses the pico-droplet generator has a hydrophobic surface surrounding the selection hole (As also shown, hydrophobic material 1508 can be disposed on the upper surface 104 around the upper opening 1502 of the output passage 116. Para. [0098], Fig. 15), and the pressure balance device enables the liquid specimen to form a liquid level in the selection hole that is coplanar with an outer surface of the bonding layer (The hydrophobic material 1508 can repel the medium 122, which can impede the medium 122 from entering the output passage 116 until the outputting mechanism 114 is activated to express a droplet 126 (see FIG. 1C). para. [0098]).
Regarding claim 11, Khandros and Wu disclose the claimed invention as discussed above in claim 1. Khandros pico-droplet emission region is arranged in a projection area (square area of 114, Fig. 3A) defined by orthogonally projecting the selection hole onto the piezoelectric member along the dripping direction (Fig 3AB, the outputting mechanism 114 is directly above the output passage 116).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khandros and Wu in view of Panwar (WO 2023094702 A1) and Yasuda (US 20120088295 A1).
Regarding claim 9, Khandros and Wu discloses the claimed invention as discussed above in claim 1. Khandros discloses the device can be attached with a pump (Examples of such micro-fluidic circuit elements include…pumps, para. [0052]) and a first container for receiving the pico-droplet (As shown in FIG. 7A, the reservoir 808 can be adjacent the output passage 116…para. [0073]). However, neither Khandros nor Wu explicitly discloses the pressure balance device includes:
an air pump;
a switch connected to the air pump;
a pressure balance bottle being in fluid communication with the air pump and the switch;
a liquid injection bottle being in fluid communication with the switch and the first valve, wherein the liquid injection bottle enables the liquid specimen received therein to be injected into the selection channel through the first valve and the inlet; and
a second container being in fluid communication with the second valve.
Attaching a pump and reservoir at the inlet and outlet of a microfluidic device is well-known in the art. For example, in an analogous art, Panwar discloses a droplet manipulation system (400, Fig. 4) comprises “a microfluidics unit 418, which is configured to generate a fluid flow along the microfluidic channel 106. For this, the microfluidics unit 418 may for example comprise one or more pumps (not shown), one or more valves (not shown), and/or one or more reservoirs (not shown) to supply fluid to the inlet 108 and/or to withdraw fluid from one or both of the outlets 110A, 110B” (para. [0112]).
In another analogous art, Yasuda discloses a microfluidic device for cell separation or concentration by dielectrophoretic force (para. [0022]), wherein a sample liquid is introduced from a liquid inlet by a syringe pump or by air pressure (the connection to the inlet and air pressure is interpreted as “the switch”; since the fluid is introduced by “pressurized gas”, a gas cylinder or a storage container connecting to the controller for the pressurized gas is inherently taught, hence a “pressure balance bottle”).
It would have been obvious to one of ordinary skill in the art to have incorporated additional two additional containers with a pump attached to the inlet directing the flow from the inlet fluid container to the fluidic channel to the device of Khandros based on the design taught by Panwar. Doing so provides a reservoir for receiving fluid exiting the outlet and a reservoir for continuously directing fluid to the system via the inlet. Regarding the air pump system with an air pump, a pressure balance bottle/gas cylinder, and a switch connecting the pump to the switch and the microfluidic device, it would have been obvious to one of the ordinary skilled in the art to have adopt an air pump/pressurized gas system to the device of Khandros based on the teaching of Yasuda. Integrating an air pump/pressurized gas system for introducing fluid allows for a stable, continuous laminar flow instead of oscillating flow profile using syringe pump (…on the chip 10 by a syringe pump or cell introducing means such as air pressure which does not generate a pulsatile flow. Para. [0053], Yasuda).
Claim(s) 10, 12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khandros and Wu.
Regarding claim 10 Khandros and Wu disclose the claimed invention as discussed above in claim 1. Neither Khandros nor Wu discloses the width of the selection hole or the boundary of the viewable segment is spaced apart from a center of the selection hole along the flow direction by a distance within the claimed range.
Regarding the limitation of the size/width of the hole, Khandros discloses the device is designed to be used with cells such as hydridoma cell (para. [0121]), which has an average diameter around 15 microns. It is Examiner’s position that it would have been obvious to one of ordinary skill in the art to have sized the selection holes to claimed value of 40 microns to accommodate for the droplet encapsulating hydridoma cell (with average diameter of 15 microns). It is the Examiner’s position that the disclosed values (40 microns) are close enough that one of ordinary skill in the art before the effective filing date of the invention would have expected the same properties. Case law holds that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding the limitation of boundary of the viewable segment is spaced apart from a center of the selection hole along the flow direction by a distance range from 100 to 300 microns, Wu discloses “optoelectrowetting (OEW) enables control of microfluids in droplet form by optical beams and is based on light induced electrowetting, which changes surface tension at solid-liquid interface at illuminated area” (Col. 3, lines 55-59), with increasing the distance between the boundary and the center of selection hole also increase the illuminated area. The illuminated area also results a nonuniform electric field and cells or particles in the liquid layer are polarized by this non-uniform electric field and driven by the DEP (dielectrophoresis) force (Col. 4, lines 8-11).
As the illuminated area and strength of electric field are variables that can be modified, among others, by adjusting the distance between the boundary and selection hole, with illuminated area both increasing as the distance is increased, the precise distance would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed distance cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the distance in Khandros to obtain the desired balance between the illuminated area and non-uniform electric field strength as taught by Wu (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 12, Khandros and Wu disclose the claimed invention as discussed above in claim 11. Neither Khandros nor Wu discloses the boundary of the pico-droplet emission region is spaced apart from a center of the selection hole along the dripping direction by a distance within the claimed range.
Regarding the limitation of boundary of the pico-droplet emission region is spaced apart from a center of the selection hole along the dripping direction by a distance range from 50 to 200 microns (interpreted as the depth), Khandros discloses the size or dimension of the output passage 116/pico-droplet is sized and positioned such that that the liquid medium forms a meniscus (para. [0073] and Fig. 7).
Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the depth of the outer passage (also the diameter) in Khandros to obtain the desired balance between the stability and shape of the meniscus as taught by Khandros (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).Regarding claim 15, Khandros and Wu disclose the claimed invention as discussed above in claim 14. Khandros discloses the pico-droplet generator has a hydrophobic surface surrounding the selection hole (As also shown, hydrophobic material 1508 can be disposed on the upper surface 104 around the upper opening 1502 of the output passage 116. Para. [0098], Fig. 15), and the pressure balance device enables the liquid specimen to form a liquid level in the selection hole that is coplanar with an outer surface of the bonding layer (The hydrophobic material 1508 can repel the medium 122, which can impede the medium 122 from entering the output passage 116 until the outputting mechanism 114 is activated to express a droplet 126 (see FIG. 1C). para. [0098]). Furthermore, Khandros discloses the pico-droplet emission region is arranged in a projection area (square area of 114, Fig. 3A) defined by orthogonally projecting the selection hole onto the piezoelectric member along the dripping direction (Fig 3AB, the outputting mechanism 114 is directly above the output passage 116).
Neither Khandros nor Wu discloses the width of the selection hole or the boundary of the viewable segment is spaced apart from a center of the selection hole along the flow direction by a distance within the claimed range.
Regarding the limitation of the size/width of the hole, Khandros discloses the device is intended to be used with cells such as hydridoma cell (para. [0121]), which has an average diameter around 15 microns. It is Examiner’s position that it would have been obvious to one of ordinary skill in the art to have sized the selection holes to claimed value of 40 microns to accommodate for the droplet encapsulating hydridoma cell (with average diameter of 15 microns). It is the Examiner’s position that the disclosed values (40 microns) are close enough that one of ordinary skill in the art before the effective filing date of the invention would have expected the same properties. Case law holds that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding the limitation of boundary of the viewable segment is spaced apart from a center of the selection hole along the flow direction by a distance range from 100 to 300 microns (claim 10) or 50 to 200 microns (claim 12), Wu discloses “optoelectrowetting (OEW) enables control of microfluids in droplet form by optical beams and is based on light induced electrowetting, which changes surface tension at solid-liquid interface at illuminated area” (Col. 3, lines 55-59), with increasing the distance between the boundary and the center of selection hole also increase the illuminated area. The illuminated area also results a nonuniform electric field and cells or particles in the liquid layer are polarized by this non-unifoorm electric field and driven by the DEP (dielectrophoresis) force (Col. 4, lines 8-11).
As the illuminated area and strength of electric field are variables that can be modified, among others, by adjusting the distance between the boundary and selection hole, with illuminated area both increasing as the distance is increased, the precise distance would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed distance cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the distance in Khandros to obtain the desired balance between the illuminated area and non-uniform electric field strength as taught by Wu (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2008/286751 A1 discloses dripping direction can be varied with different direction/axis (para. [0081]-[0099] and Fig. 1-5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 5712707698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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