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 .
Status of the Claims
The Amendment filed 11/24/2025 has been entered. Claims 1-2, 4-7, and 9 have been amended. Claim 15 is new. Claims 1-7, 9-10, and 13-15 are currently pending and are examined herein.
Status of the Rejection
New grounds of objections to the claims are necessitated by the amendments as outlined below.
All 35 U.S.C. § 112(a) and 112(b) rejections from the previous office action are withdrawn.
New grounds of rejection under 35 U.S.C. § 112(b) are necessitated by the amendments as outlined below.
All 35 U.S.C. § 103 rejections for claims 1-7, 9-10, and 13-14 from the previous office action are essentially maintained and modified only in response to the amendments to the claims. New grounds of rejection under 35 U.S.C. § 103 for new independent claim 15 are necessitated by the amendments as outlined below.
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15, line 9: please amend “the upper-most” to –an uppermost-.
Claim 15, line 12: please amend “micro-fluidics” to --microfluidics --.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 13, and 15 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.
Regarding claim 2, claim 2 recites “the cartridge (17)” in the second to last line of the claim. Claim 2 was amended to recited “a cartridge”, such as in lines 11-12, without any numbering behind the term. It is unclear if the cartridge 17 is the same cartridge as previously recited or a different, newly recited cartridge. Applicant should clarify the difference between the two cartridges. Therefore, the scope of claim 2 is indefinite. Claim 13 is further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 2.
Regarding claim 15, claim 15 recites the term "small volume" in line 1 and is a relative term which renders the claim indefinite. The term "small volume" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The examiner notes that while the specification does mention a small volume, usually in the micro- or nanoscale format (Para. 0002), it does not provide a standard or definition to what a small volume is. For example, a microscale format could be one liter (which is equivalent to 1000 microliters) and as no units are recited, it is unclear what a constitutes a small volume. Therefore, the scope of claim 15 is indefinite.
Regarding claim 15, claim 15 recites the limitation "the two hydrophobic surfaces" in the context of the working gap in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear if the two hydrophobic surfaces are a new and different element in the context of the working gap, or if they are the same as and are referring to the first hydrophobic surface [of the working film] and the second hydrophobic surface [of the rigid cover plate] previously recited in the claim. If they are the same, the examiner suggests amending the claim to say “located in-between the first hydrophobic surface and the second hydrophobic surface”. Therefore, the scope of claim 15 is indefinite.
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.
Claim(s) 1 – 7, 9-10, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lay et al. (US 2014/0190832 A1) in view of Adleff et al. (US20090129945A1) and Hafeman et al. (US20040197905A1).
Regarding claim 1, a method for control and manipulation of liquids (Lay teaches a method for a digital microfluidics system that controls and manipulates liquids, Abstract), the method comprising the steps of:
providing a cartridge with a working gap and a flexible working film that comprises a semi-permeable constitution with respect to gas or a semi-permeable property with respect to gas (Lay teaches a cartridge 2 with a working gap 6 and a flexible working film 3 comprising the possible materials of fluorinated ethylene propylene (FEP), cyclo olefin polymer (COP) with a thickness/foil of 8-50 microns (Page 8, Table 1). While Lay does not expressly provide the flexible working film has a semi-permeable property, the films described by Lay are made from the same materials (i.e., COP, FEP) and provided at an identical thickness (8-50 microns) as taught by the instant specification (see Table 1 of the instant specification) which Applicant ascribes as a property of the film or material (see specification page 22, lines 4-6). Since the materials and thickness of the disclosed flexible working film of Lay are the same as the instant application, they have the same inherent semi-permeable property or constitution with respect to gas. Accordingly, products of identical chemical composition cannot have mutually exclusive properties, and thus, the claimed property (i.e. semi-permeable constitution with respect to gas or a semi-permeable property with respect to gas), is necessarily present in the prior art material. [See MPEP 2112.01 (II)]. Furthermore, since the prior art of Lay utilizes the same materials and/or classes of materials at the same exact thickness disclosed by the applicant, one having ordinary skill in the art would have expected that the use of the same materials at the same thickness would result necessarily in the flexible working film having the same properties (i.e., semi-permeable property or constitution with respect to gas). The examiner notes that the instant specification does not contain any additional information about any specific treatment of the materials or any special manufacturing processes, only disclosing the types of possible materials and the foil/thickness, which are exactly the same as the film disclosed by the prior art Lay as described above.);
Alternative to the finding of inherency above, the following rejection grounds rely upon additional evidence (Adleff et al.) showing that the claimed invention is obvious. Adleff discloses a micropump designed to control displacement of fluids appropriate for many applications such as different microfluidic applications like microanalytics, micro reaction technology, lab-on-a-chip applications, point-of-care diagnostics and drug-delivery devices [Paras. 0002-0003]. Adleff further teaches a compartment with a semi-permeable membrane [corresponding to a film] with a portion of or the complete semi-permeable membrane comprised of a gas-permeable material, thus having a semi-permeable property or constitution with respect to gas [Para. 0028, Fig. 1, Para. 0003]. Adleff teaches it would be beneficial for the film/membrane to be semi-permeable because gas bubbles will be pushed therethrough and removed, where gas bubbles are undesirable as they reduce and affect the flow rate [Para. 0028].
Lay and Adleff are considered analogous art to the claimed invention because they are in the same field of applications for microfluidic devices [Abstract of Lay and Paras. 0002-0003 of Adleff]. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify a property or constitution of the flexible working film of Lay to be semi-permeable with respect to gas, as taught by Adleff, since Adleff teaches it would be beneficial as gas bubbles will be pushed therethrough the membrane/film and removed, where gas bubbles are undesirable as they reduce and affect the flow rate, which is relevant for fluids in microfluidics applications [Para. 0028 and 0002-0003]. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results, MPEP 2143[I][A].
positioning said cartridge at a cartridge accommodation site of a digital microfluidics system and sealingly enclosing the cartridge in said cartridge accommodation site (Lay teaches the cartridge 2 is positioned/slidingly inserted into a cartridge accommodation site 8 of a digital microfluidics system 1, where the cartridge 2 is precisely seated and sealingly enclosed in the cartridge accommodation site 8 [see e.g., Figs. 1-3, Para. 0043, 0039, 0052-0054, 0101-0102]); and
providing an amount of underpressure in the cartridge accommodation site (Lay teaches providing an underpressure [which necessarily has an amount] in the evacuation space 46 inside the working gap 6 of the cartridge 2 by using a vacuum source 33 for establishing the underpressure in the evacuation space 46 that is located between the bottom substrate 11 (equivalent to the uppermost surface of the cartridge accommodation site 8) and the backside or bottom-most surface of the flexible working film 3, thus is an amount of underpressure in the cartridge accommodation site (Para. 0079, 0081 and Fig. 3).
The limitation “so that bubbles are prevented from forming inside the working gap of the cartridge” is an intended result of a positively recited step. The court noted that a '“whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat'l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). MPEP 2111.04(I). Examiner notes, however, that since the prior art does disclose a process and device for providing an amount of underpressure in the cartridge accommodation site comprising substantially the same elements or components as that of the applicant and applied to the same location of the instant application, as taught by the instant specification (see specification page 16, lines 11-13, and see claims 2, 7, 9, and 10, it is contended that the process and amount of underpressure applied in the prior art inherently performs the claimed process and is capable of so that bubbles are prevented from forming inside the working gap of the cartridge. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process, and thus, the claimed property or function (i.e., so that bubbles are prevented from forming inside the working gap (4) of the cartridge (17)), is necessarily present in the prior art material. [See MPEP 2112.02 (I)].
In the alternative, Hafeman teaches a microfluidic device system [Abstract]. Hafeman teaches application of a negative pressure i.e., a vacuum [corresponding to an underpressure], where the pressure (negative or positive) will be between e.g., 0.1 psi and 3.0 psi [thus teaching -0.1 psi and -3.0 psi since Hafeman discloses the pressure can be negative to reduce gas bubble formation [corresponding to bubbles are prevented from forming] within the channels [corresponding to a working gap], which is beneficial because bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125].
Lay and Hafeman are considered analogous art to the claimed invention because they are in the same field of microfluidic devices [Abstract of Lay and Hafeman]. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of underpressure in the cartridge accommodation site of Lay to be an amount between -0.1 psi and -3.0 psi so that bubbles are prevented from forming within the working gap/channel, as taught by Hafeman, of the cartridge of Lay, since Hafeman teaches it would be beneficial since bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125 of Hafeman]. Furthermore, the use of a known technique to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Regarding claim 2, a method for controlling and manipulating liquids (Lay teaches a method for a digital microfluidics system that controls and manipulates liquids, Abstract and Para. [0002]), the method comprising the steps of:
providing a digital microfluidics system (Lay teaches providing a digital microfluidics system 1, Para. [0039] and Figs 2 and 3) comprising:
a number or array of individual electrodes attached to a first substrate or PCB (Lay teaches an electrode array 9 comprising a number of individual electrodes 10 that are attached to a bottom/first substrate 11, Para. [0042] and Figs 2 and 3);
a central control unit in operative contact with said number or array of individual electrodes for controlling selection and for providing a number of said number or array of individual electrodes that define a path of individual electrodes with voltage for manipulating liquid portions or liquid droplets by electrowetting (Lay teaches a central control unit 14 for controlling the selection of the number of individual electrodes 10 and for providing these number of individual electrodes 10 which define a horizonal path along the substrate of individual electrodes 10 with individual voltage pulses for manipulating liquid droplets by electrowetting, Para. [0045] and Figs 2 and 3); and
a cartridge accommodation site that is configured for taking up a cartridge (Lay teaches a cartridge accommodation site 8 that is configured for taking up a disposable cartridge 2, Para. [0040] and Figs 2 and 3);
providing the cartridge which comprises a first hydrophobic surface that belongs to a flexible working film comprising a backside, a second hydrophobic surface that belongs to a cover plate of the cartridge, and a working gap that is located in-between the first hydrophobic surface and the second hydrophobic surface) (Lay teaches the cartridge 2 comprising a first hydrophobic surface 17’ of the bottom layer 3 configured as a flexible working film 3, a top layer 4 with a second hydrophobic surface 17” [the top layer 4 is attached to the cover plate 12] of the cartridge 2, and a working gap 6 that is located between the first hydrophobic surface 17’ and the second hydrophobic surface 17”, Para. [0040], [0051 – 0052] and Figs 2 and 3. The flexible working film 3 comprises a backside which corresponds to its bottommost surface on the side near the cartridge accommodation side 8, Fig. 2 and 3, Para. [0043]),
wherein the flexible working film comprises a semi-permeable constitution with respect to gas or a semi-permeable property with respect to gas (Lay teaches the cartridge 2 with the flexible working film 3 comprising the possible materials of fluorinated ethylene propylene (FEP), cyclo olefin polymer (COP) with a thickness/foil of 8-50 microns (Page 8, Table 1). While Lay does not expressly provide the flexible working film has a semi-permeable property, the films described by Lay are made from the same materials (i.e., COP, FEP) and provided at an identical thickness (8-50 microns) as taught by the instant specification (see Table 1 of the instant specification) which Applicant ascribes as a property of the film or material (see specification page 22, lines 4-6). Since the materials and thickness of the disclosed flexible working film of Lay are the same as the instant application, they have the same inherent semi-permeable property or constitution with respect to gas. Accordingly, products of identical chemical composition cannot have mutually exclusive properties, and thus, the claimed property (i.e. semi-permeable constitution with respect to gas or a semi-permeable property with respect to gas), is necessarily present in the prior art material. [See MPEP 2112.01 (II)]. Furthermore, since the prior art of Lay utilizes the same materials and/or classes of materials at the same exact thickness disclosed by the applicant, one having ordinary skill in the art would have expected that the use of the same materials at the same thickness would result necessarily in the flexible working film having the same properties (i.e., semi-permeable property or constitution with respect to gas). The examiner notes that the instant specification does not contain any additional information about any specific treatment of the materials or any special manufacturing processes, only disclosing the types of possible materials and the foil/thickness, which are exactly the same as the film disclosed by the prior art Lay as described above.);
Alternative to the finding of inherency above, the following rejection grounds rely upon additional evidence (Adleff et al.) showing that the claimed invention is obvious. Adleff discloses a micropump designed to control displacement of fluids appropriate for many applications such as different microfluidic applications like microanalytics, micro reaction technology, lab-on-a-chip applications, point-of-care diagnostics and drug-delivery devices [Paras. 0002-0003]. Adleff further teaches a compartment with a semi-permeable membrane [corresponding to a film] with a portion of or the complete semi-permeable membrane comprised of a gas-permeable material, thus having a semi-permeable property or constitution with respect to gas [Para. 0028, Fig. 1, Para. 0003]. Adleff teaches it would be beneficial for the film/membrane to be semi-permeable because gas bubbles will be pushed therethrough and removed, where gas bubbles are undesirable as they reduce and affect the flow rate [Para. 0028].
Lay and Adleff are considered analogous art to the claimed invention because they are in the same field of applications for microfluidic devices [Abstract of Lay and Paras. 0002-0003 of Adleff]. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify a property or constitution of the flexible working film of Lay to be semi-permeable with respect to gas, as taught by Adleff, since Adleff teaches it would be beneficial as gas bubbles will be pushed therethrough the membrane/film and removed, where gas bubbles are undesirable as they reduce and affect the flow rate, which is relevant for fluids in microfluidics applications [Para. 0028 and 0002-0003]. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results, MPEP 2143[I][A].
positioning said cartridge at the cartridge accommodation site of said digital microfluidics system ; (Lay teaches the cartridge 2 is positioned/slidingly inserted into the cartridge accommodation site 8 of the digital microfluidics system 1, Fig. 2 and 3, Para. [0043]);
providing at least one liquid portion or liquid droplet on the first hydrophobic surface and above the path of individual electrodes (Lay teaches providing a liquid droplet 23 on the first hydrophobic surface 17’ and above the path of individual electrodes 10, Para. [0051] and Figure 3); and
using a vacuum source of the digital microfluidics system to provide an amount of underpressure established in an evacuation space between an uppermost surface of the cartridge accommodation site and the backside of the flexible working film of the cartridge (17) (Lay teaches using a vacuum source 33 of the digital microfluidics system 1 for providing an underpressure [which necessarily has an amount] in an evacuation space 46 that is located between the bottom substrate 11 (equivalent to the uppermost surface of the cartridge accommodation site 8) and the backside or bottom-most surface of the flexible working film 3 of the cartridge 2, Figure 3 and Para. [0079])
the limitation “that prevents the formation of bubbles in the working gap” is an intended result of a positively recited step. The court noted that a '“whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat'l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). MPEP 2111.04(I). Examiner notes, however, that since the prior art does disclose a process and device for providing an amount of underpressure in an evacuation space 46 that is located between the bottom substrate 11 (equivalent to the uppermost surface of the cartridge accommodation site 8) and the backside or bottom-most surface of the flexible working film 3 of the cartridge 2 comprising substantially the same elements or components as that of the applicant and applied to the same location of the instant application, as taught by the instant specification (see specification page 16, lines 11-13, and see claims 2, 7, 9, and 10), it is contended that the process and amount of underpressure applied in the prior art inherently performs the claimed process and is capable of that prevents the formation of bubbles in the working gap. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process, and thus, the claimed property or function (i.e., that prevents the formation of bubbles in the working gap), is necessarily present in the prior art material. [See MPEP 2112.02 (I)].
In the alternative, Hafeman teaches a microfluidic device system [Abstract]. Hafeman teaches application of a negative pressure, i.e., a vacuum [corresponding to an underpressure], where the pressure (negative or positive) will be between e.g., 0.1 psi and 3.0 psi [thus teaching -0.1 psi and -3.0 psi since Hafeman discloses the pressure can be negative] to reduce gas bubble formation [corresponding to prevents the formation of bubbles] within the channels [corresponding to a working gap], which is beneficial because bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125].
Lay and Hafeman are considered analogous art to the claimed invention because they are in the same field of microfluidic devices [Abstract of Lay and Hafeman]. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of underpressure in the evacuation space between the bottom substrate 11 (equivalent to the uppermost surface of the cartridge accommodation site 8) and the backside or bottom-most surface of the flexible working film 3 of the cartridge 2 of Lay to be an amount between -0.1 psi and -3.0 psi that prevents the formation of bubbles in the working gap/channel, as taught by Hafeman, since Hafeman teaches it would be beneficial since bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125 of Hafeman]. Furthermore, the use of a known technique to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Regarding claim 3, the method according to claim 1, wherein the underpressure is in a range of -2 psi to -6 psi (Modified Lay yields the underpressure is between -0.1 psi and -3.0 psi, which overlaps the claimed range [see rejection of claim 1 above and Paras. 0083, 0109, 0100, 0125 of Hafeman]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected and utilized an underpressure within the disclosed range, as taught by Modified Lay, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range to be suitable given that Modified Lay specifically teaches the range to be suitable underpressure to reduce gas bubble formation [corresponding to bubbles are prevented from forming] within the channels [corresponding to a working gap]. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 [I].)
Regarding claim 4, the method according to claim 1, wherein the flexible working film is configured for being attracted as an entire flexible working film (Lay teaches the flexible (working) bottom layer 3 is attracted and spread over the electrode array 9 and bottom substrate 11, so that the entire flexible working film 3 is attracted to the electrode array 9 and the bottom substrate 11, and thus is specifically configured to perform the functional limitations above [Para. 0072]).
Regarding claim 5, the method according to claim 1, wherein the cartridge comprises a rigid cover plate evenly defining a top of said working gap (Lay teaches the cartridge 2 comprises a rigid cover plate 12 and this cover rigid cover plate 12 evenly defines a top of the working gap 6 as seen in Figure’s 2 and 3, Para. [0054]).
Regarding claim 6, the method according to claim 1, wherein the cartridge or the cartridge accommodation site comprises a gasket, with which the evacuation space is sealingly enclosed and a height of the working gap between a first hydrophobic surface and a second hydrophobic surface is defined (Lay teaches the cartridge accommodate site 8 comprises a gasket 36, where the evacuation space 46 is sealingly enclosed by the gasket 36 located around a circumference 45 of the catridge accommodation site 8, and that the gasket 36 defines the distance/height of the working gap 6 between a first hydrophobic surface 17’ and a second hydrophobic surface 17”, Para. [0060 and 0102] and Fig. 3).
Regarding claim 7, the method according to claim 1, wherein a positioning of said cartridge at the cartridge accommodation site comprises touching an uppermost surface of the cartridge accommodation site with a backside of the flexible working film when the cartridge is accommodated on said cartridge accommodation site (Lay teaches wherein a positioning or transporting of the cartridge 2 at the cartridge accommodation site 8 by front or top loading of the cartridge into the accommodating site [Para. 0043] and comprises touching the bottom substrate 11/uppermost surface of the cartridge accommodation site 8 with the backside/bottommost surface of the flexible working film 3 when the cartridge 2 is loaded/slidingly inserted/accommodated on the cartridge accommodation site 8, as seen in Figs. 2 and 3, Para. [0081]).
Regarding claim 9, the method according to claim 1 comprising the step of: providing the cartridge with the flexible working film (See the outlined rejection in claim 1 above where modified Lay describes a cartridge with a flexible working film), wherein the cartridge is configured to control and manipulate the liquids (Lay teaches the cartridge 2 of the digital microfluidics system 1 that is configured for controlling and manipulating liquid droplets, Para. [0039]) and to be positioned at the cartridge accommodation site of the digital microfluidics system (Lay teaches positioning or transporting of the cartridge 2 at a cartridge accommodation site 8 by front or top loading of the cartridge into the accommodating site [Para. 0043]), wherein the cartridge comprises a rigid cover plate, a first hydrophobic surface that belongs to the flexible working film, a second hydrophobic surface that belongs to the rigid cover plate and the working gap that is located in-between the first hydrophobic surface and the second hydrophobic surface (Lay teaches the cartridge 2 comprises a rigid cover plate 12, a first hydrophobic surface 17’ that belongs to the flexible working film 3, a second hydrophobic surface 17” that belongs to the rigid cover plate 12 and top layer 4, and a working gap 6 that is located in between the first hydrophobic surface 17’ and the second hydrophobic surface 17”, Fig. 3, Para. [0054] and [0051 – 0052]) the flexible working film comprising a backside that, when the cartridge is accommodated on the cartridge accommodation site, provides an evacuation space between an uppermost surface of the cartridge accommodation site and the backside for establishing the underpressure produced in the evacuation space produced by a vacuum source of the digital microfluidics system (Modified Lay teaches the flexible working film 3 with a backside (that is equivalent to the bottommost surface of the film on the side near the cartridge accommodation site 8) that when the cartridge 2 is loaded/inserted/positioned on the cartridge accommodation site 8 provides an evacuation space 46 that is located between the bottom substrate 11 (equivalent to the uppermost surface of the cartridge accommodation site 8) and the backside or bottom-most surface of the flexible working film 3 for establishing the underpressure produced in the evacuation space 46 by a vacuum source 33 of the digital microfluidics system 1, [Figure 2 and 3; Paras. 0079, 0043, 0081 of Lay]).
Regarding claim 10, the method according to claim 1 comprising the step of: providing a vacuum source for establishing the underpressure in an evacuation space between an uppermost surface of the cartridge accommodation site and a backside of the flexible working film (Modified Lay teaches providing a vacuum source 33 for establishing the underpressure in an evacuation space 46 that is located between the bottom substrate 11 (equivalent to the uppermost surface of the cartridge accommodation site 8) and the backside or bottom-most surface of the flexible working film 3, [see rejection of claim 1 above, see e.g., Figure 3 and Para. [0079] of Lay]).
Regarding claim 13, the method according to claim 2, wherein the cartridge is a disposable cartridge (Lay teaches the cartridge 2 is a disposable cartridge, Para. [0040], [0051 – 0052] and Figs 2 and 3).
Regarding claim 14, the method according to claim 7, wherein the method comprises spreading the flexible working film on the uppermost surface of the cartridge accommodation site upon providing the underpressure (Modified Lay teaches the method comprises spreading of the flexible working layer 3 over the bottom substrate 11/uppermost surface of the cartridge accommodation site 8 upon providing the underpressure in the evacuation space 46, [see e.g., rejections above and Para. [0081] of Lay).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lay et al. (US 2014/0190832 A1) in view of Hafeman et al. (US20040197905A1).
Regarding claim 15, a method for controlling and manipulating liquids in a small volume within a digital microfluidics system that comprises a cartridge accommodation site (Lay teaches a method for a digital microfluidics system that controls and manipulates liquids in a small volume/droplet, the digital microfluidics system comprises a cartridge accommodation site 18, [Abstract; Para. 0040; Figs. 2 and 3]), the method comprising the steps of:
providing a cartridge that comprises a flexible working film, a rigid cover plate, a first hydrophobic surface that belongs to the flexible working film, a second hydrophobic surface that belongs to the rigid cover plate, and a working gap that is located in-between the two hydrophobic surfaces (Lay teaches providing a cartridge 2 that comprises a flexible working film 3, a rigid cover plate 12, a first hydrophobic surface 17’ that belongs to the flexible working film 3, a second hydrophobic surface 17” that belongs to the rigid cover plate 12 and top layer 4, and a working gap 6 that is located in between the first hydrophobic surface 17’ and the second hydrophobic surface 17”, [Fig. 3, Para. 0054 and 0051 – 0052]);
accommodating the cartridge on the cartridge accommodation site such that a backside of the flexible working film provides an evacuation space between the upper-most surface of the cartridge accommodation site and the backside (Lay teaches the cartridge 2 is positioned/slidingly inserted into a cartridge accommodation site 8 of a digital microfluidics system 1, where the cartridge 2 is precisely seated and sealingly enclosed in the cartridge accommodation site 8 [see e.g., Figs. 1-3, Para. 0043, 0039, 0052-0054, 0101-0102]. Lay further teaches the flexible working film 3 with a backside (that is equivalent to the bottommost surface of the film on the side near the cartridge accommodation site 8) that when the cartridge 2 is loaded/inserted/positioned on the cartridge accommodation site 8 provides an evacuation space 46 that is located between the bottom substrate 11 (equivalent to the uppermost surface of the cartridge accommodation site 8) and the backside or bottom-most surface of the flexible working film 3 [Figure 2 and 3; Paras. 0079, 0043, 0081 of Lay]);
providing an underpressure Lay teaches providing an underpressure in the evacuation space 46 inside the working gap 6 of the cartridge 2 by using a vacuum source 33 of the digital microfluidics system 1 for establishing the underpressure in the evacuation space 46 that is located between the bottom substrate 11 (equivalent to the uppermost surface of the cartridge accommodation site 8) and the backside or bottom-most surface of the flexible working film 3 (Para. 0079, 0081 and Fig. 3)
Lay is silent to an underpressure in a range of -2 psi to -6 psi.
Hafeman teaches a microfluidic device system [Abstract]. Hafeman teaches application of a negative pressure i.e., a vacuum [corresponding to an underpressure], where the pressure (negative or positive) will be between e.g., 0.1 psi and 3.0 psi [thus teaching -0.1 psi and -3.0 psi since Hafeman discloses the pressure can be negative to reduce gas bubble formation [corresponding to bubbles are prevented from forming] within the channels [corresponding to a working gap] and which overlaps the claimed range, which is beneficial because bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125].
Lay and Hafeman are considered analogous art to the claimed invention because they are in the same field of microfluidic devices [Abstract of Lay and Hafeman]. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of underpressure in the cartridge accommodation site of Lay to be an amount between -0.1 psi and -3.0 psi, which overlaps the claimed range, so that bubbles are prevented from forming within the working gap/channel, as taught by Hafeman, of the cartridge of Lay, since Hafeman teaches it would be beneficial since bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125 of Hafeman]. Furthermore, the use of a known technique to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected and utilized an underpressure within the disclosed range, as taught by Modified Lay, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range to be suitable given that Modified Lay specifically teaches the range to be suitable underpressure to reduce gas bubble formation [corresponding to bubbles are prevented from forming] within the channels [corresponding to a working gap]. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 [I].)
The limitation “for avoiding bubbles inside the working gap of the cartridge” is an intended result of a positively recited step. The court noted that a '“whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat'l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). MPEP 2111.04(I). Examiner notes, however, that since the prior art does disclose a process and device for providing an amount of underpressure in the cartridge accommodation site with having selected and utilized an underpressure within the disclosed range, as taught by Modified Lay, including those amounts that overlap within the claimed range, the method of Modified Lay comprising substantially the same elements or components as that of the applicant [the same amount of underpressure applied in the overlapping range of -2 psi to -3 psi] and applied to the same location of the instant application, as taught by the instant specification (see specification page 16, lines 11-13, and see claims 2, 7, 9, and 10, it is contended that the process and amount of underpressure applied in the prior art inherently performs the claimed process and is capable of so that bubbles are prevented from forming inside the working gap of the cartridge. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process, and thus, the claimed property or function (i.e., so that bubbles are prevented from forming/avoiding bubbles inside the working gap (4) of the cartridge (17)), is necessarily present in the prior art material. [See MPEP 2112.02 (I)]. Furthermore, as outlined in the rejection above, Modified Lay specifically teaches applying the same amount of underpressure in the cartridge accommodation site, so that bubbles are prevented from forming within the working gap/channel, as taught by Hafeman, of the cartridge of Lay, since Hafeman teaches it would be beneficial since bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125 of Hafeman] and it would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected and utilized an underpressure within the disclosed range, as taught by Modified Lay, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range to be suitable given that Modified Lay specifically teaches the range to be suitable underpressure to reduce gas bubble formation [corresponding to bubbles are prevented from forming] within the channels [corresponding to a working gap]. Thus, modified Lay necessarily yields “for avoiding bubbles inside the working gap of the cartridge” as outlined in the rejections above.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 8-14, filed 11/24/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered and are not persuasive.
Applicant’s Argument #1:
Applicant argues on pages 9-10 that Lay does not inherently disclose a flexible working film that is semi-permeable. Applicant further argues on page 11 that the rejection of independent claims 1 and 2, and the claims dependent thereon is based on a misapplication of inherency, an unsupported assumption that identical materials necessarily possess identical gas-permeability behavior under vacuum, an improper hindsight-driven modification of Lay using teachings from unrelated technologies, and an excessively broad interpretation of Lay that contradicts the explicit teachings of that reference.
Applicant argues on page 11 that Lay never suggests, hints, or implies that its flexible film functions as a gas-permeable membrane, let alone that gas transport through the film plays any role in the system's operation. Lay is directed to droplet manipulation in a sealed electrowetting cartridge, not gas equilibration, gas evacuation, or bubble suppression through a membrane. The Examiner's reliance on "identical materials cannot have mutually exclusive properties" is too simplistic for polymer behavior under vacuum conditions. Polymer permeability to gases is not a binary property that applies uniformly across all device architectures. Permeation depends heavily on film orientation, surface treatments, barrier coatings, laminations, crystallinity, filler content, and even environmental conditions, none of which Lay discloses or equates with Applicant's system. The Examiner asserts that Applicant's disclosure "ascribes" gas semi- permeability to the materials themselves, but this mischaracterizes the specification. Applicant's disclosure is not that every FEP or COP film at 8-50 µm is inherently gas-permeable, but rather that in the context of the disclosed electrowetting cartridge under the applied underpressure, the flexible film exhibits a semi-permeable property that contributes to bubble avoidance. Lay's materials, in Lay's structure, under Lay's operating conditions, are not shown to share this property.
Applicant further argues on page 12 that the flexible film in Lay is a structural boundary layer, not a gas-exchange membrane. Without any affirmative teaching in Lay that gas transport occurs or was intended to occur, inherency cannot be invoked. The Examiner's conclusion that Lay's film "necessarily" has gas semi-permeability is unsupported speculation, and speculation cannot substitute for evidence of inherency.
Examiner’s Response #1:
The Examiner respectfully disagrees and applicant’s arguments are unpersuasive. The applicant has not provided any evidence the material of Lay does not comprise a semi-permeable constitution or semi-permeable property. As explained previously, once the examiner presents evidence or reasoning tending to support the determination of inherency, then the burden shifts to applicant to rebut such evidence (MPEP 2112 (IV)-(V)). The examiner has clearly presented evidence and reasoning tending to support the determination of inherency [see rejections of claims 1-2 above]. As outlined in the rejections above, Lay teaches a cartridge 2 with a working gap 6 and a flexible working film 3 comprising the possible materials of fluorinated ethylene propylene (FEP), cyclo olefin polymer (COP) with a thickness/foil of 8-50 microns (Page 8, Table 1). While Lay does not expressly provide the flexible working film has a semi-permeable property, the films described by Lay are made from the same materials (i.e., COP, FEP) and provided at an identical thickness (8-50 microns) as taught by the instant specification (see Table 1 of the instant specification) which Applicant ascribes as a property of the film or material (see specification page 22, lines 4-6). Since the materials and thickness of the disclosed flexible working film of Lay are the same as the instant application, they have the same inherent semi-permeable property or constitution with respect to gas. Accordingly, products of identical chemical composition cannot have mutually exclusive properties, and thus, the claimed property (i.e. semi-permeable constitution with respect to gas or a semi-permeable property with respect to gas), is necessarily present in the prior art material. [See MPEP 2112.01 (II)]. Furthermore, since the prior art of Lay utilizes the same materials and/or classes of materials at the same exact thickness disclosed by the applicant, one having ordinary skill in the art would have expected that the use of the same materials at the same thickness would result necessarily in the flexible working film having the same properties (i.e., semi-permeable property or constitution with respect to gas). The examiner notes that the instant specification does not contain any additional information about any specific treatment of the materials or any special manufacturing processes, only disclosing the types of possible materials and the foil/thickness, which are exactly the same as the film disclosed by the prior art Lay as described above. Thus, the burden shifts to applicant to rebut such evidence.
The Applicant has stated permeation depends heavily on film orientation, surface treatments, barrier coatings, laminations, crystallinity, filler content, and even environmental conditions, without any citations to, evidence from, or explanations of the prior art of record. As such, these statements are conclusory and Applicant’s remarks have been considered in accordance with MPEP 716.01[C] [“The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Furthermore, none of these variables are disclosed by the instant specification in regards to the permeation of the film. If permeation depends heavily on film orientation, surface treatments, barrier coatings, laminations, crystallinity, filler content, and even environmental conditions, as applicant claims, one of ordinary skill in the art would expect these features to be disclosed in the instant specification. As outlined above, the prior art discloses identical materials and thickness. Applicant has not disclosed any special manufacturing processes for FEP and COP, therefore, there is nothing in the applicant's specification to indicate that anything other than generic FEP and COP are used. There is only one mention of the word "semi-permeable" in the specification, in the PG-PUB paragraph [0115], with no mention of any special polymers or processes. One of ordinary skill in the art would believe that applicant considers generic FEPs and COPs to be inherently semi-permeable, contrary to argument.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s Argument #2:
Applicant argues on page 12 that the Examiner alternatively relies on Adleff to supply the missing membrane behavior. This combination is improper because Adleff's membrane serves a completely different purpose in a completely different type of microfluidic device. Adleff's system is not an electrowetting cartridge, does not involve a working gap defined between two hydrophobic surfaces, and does not involve placing a film in a cartridge accommodation site or applying underpressure externally to that film. There is no teaching in Adleff that the membrane should be used as the flexible working film of an electrowetting cartridge, nor that it should be positioned facing an underpressure source on the backside of the film. Adleff therefore cannot reasonably motivate the skilled person to modify Lay in the manner required by the claims.
Applicant further argues on page 12 that combining Lay and Adleff would fundamentally change the operating principle of Lay's droplet-manipulation system. Lay requires a rigid, sealed environment to control electrowetting behavior with precision. Introducing a semi-permeable gas-exchange membrane, particularly at the working gap boundary, would create unpredictable droplet behavior and interfere with the electric field stability necessary for electrowetting. Adleff does not teach or suggest that its gas-permeable membrane can be used in an electrowetting device or that electrowetting droplets benefit from gas purging through a flexible film. Nothing in the cited references provides a reason, other than impermissible hindsight using Applicant's disclosure as a guide, to modify Lay's film to match the claimed invention.
Examiner’s Response #2:
The Examiner respectfully disagrees. In response to applicant's arguments against the references individually (i.e., Adleff not teaching an electrowetting cartridge, does not involve a working gap defined between two hydrophobic surfaces, and does not involve placing a film in a cartridge accommodation site or applying underpressure externally to that film) one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that Adleff is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). The prior art of Adleff et al. meets the above two conditions: (1) the reference is from the same field of endeavor, applications for microfluidic devices [Paras. 0002-0003 of Adleff], as the claimed invention; and (2) the reference is reasonably pertinent to the problem faced by the inventor (i.e., reducing gas bubbles in microfluidics applications, which are undesirable as they reduce and affect the flow rate, which is relevant for fluids in microfluidics applications, and removing gas bubbles therethrough the membrane/film [Para. 0028 and 0002-0003 of Adleff]). Applicant’s own arguments above have stated Adleff is also in the field of microfluidic devices. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. The Federal Circuit reads KSR as "direct[ing] us to construe the scope of analogous art broadly" because "familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle." [see MPEP 2141.01a]. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify a property or constitution of the flexible working film of Lay to be semi-permeable with respect to gas, as taught by Adleff, since Adleff teaches it would be beneficial as gas bubbles will be pushed therethrough the membrane/film and removed, where gas bubbles are undesirable as they reduce and affect the flow rate, which is relevant for fluids in microfluidics applications [Para. 0028 and 0002-0003].
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Adleff teaches a compartment with a semi-permeable membrane [corresponding to a film] with a portion of or the complete semi-permeable membrane comprised of a gas-permeable material, thus having a semi-permeable property or constitution with respect to gas [Para. 0028, Fig. 1, Para. 0003]. Adleff teaches it would be beneficial for the film/membrane to be semi-permeable because gas bubbles will be pushed therethrough and removed, where gas bubbles are undesirable as they reduce and affect the flow rate [Para. 0028]. Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify a property or constitution of the flexible working film of Lay to be semi-permeable with respect to gas, as taught by Adleff, since Adleff teaches it would be beneficial as gas bubbles will be pushed therethrough the membrane/film and removed, where gas bubbles are undesirable as they reduce and affect the flow rate, which is relevant for fluids in microfluidics applications [Para. 0028 and 0002-0003]. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results, MPEP 2143[I][A].
The Applicant has stated that that combining Lay and Adleff would fundamentally change the operating principle of Lay's droplet-manipulation system. Lay requires a rigid, sealed environment to control electrowetting behavior with precision. Introducing a semi-permeable gas-exchange membrane, particularly at the working gap boundary, would create unpredictable droplet behavior and interfere with the electric field stability necessary for electrowetting without any citations to, evidence from, or explanations of the prior art of record. As such, these statements are conclusory and Applicant’s remarks have been considered in accordance with MPEP 716.01[C] [“The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Furthermore, applicant’s arguments are unpersuasive. The operating principle of Lay remains unchanged as electrowetting is controlled by the applied electric field to the liquid droplet, based on the behavior of a liquid under an applied electric field or voltage. The combination of Lay and Adleff is based on modifying a property or constitution of the flexible working film of Lay to be semi-permeable with respect to gas, as gas bubbles are undesirable as they reduce and affect the flow rate, which is relevant for fluids [such as droplets] in microfluidic applications [Para. 0028 and 0002-0003 of Adleff].
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s Argument #3:
Applicant argues on pages 10 that Lay does not disclose providing an amount of underpressure in a cartridge accommodation site so that bubbles are prevented from forming inside the working gap of the cartridge. Lay does not discuss this degassing effect and thus cannot disclose anything about providing an amount of underpressure that prevents the formation of bubbles. The amount of underpressure provided to cause such attraction and spreading of the bottom layer is not strong enough to achieve the claimed degassing effect (prevention of bubbles) in order to reduce the risk of damaging the working film. In consequence, one of skill in the art would readily recognize that the underpressure applied in Lay would not be sufficient to prevent the formation of bubbles.
Applicant further argues on page 13 that while the Examiner characterizes "so that bubbles are prevented from forming" as an intended result, the limitation in context is not a mere statement of aspiration but describes the functional cooperation of the semi-permeable film and the underpressure applied to a specific evacuation space external to the cartridge. Lay's underpressure acts in a different location and for a different purpose. Lay applies vacuum to an internal space within the cartridge to actuate droplet motion. Applicant applies underpressure outside the working film, in the accommodation site, and the functional consequence of this configuration, bubble suppression via gas permeation, is fundamentally different from Lay's droplet manipulation mechanism. The Examiner's assertion that Lay's system would inherently perform the bubble-prevention function is contradicted by Lay's own depiction of bubble formation (see Lay, par. [0081]), and nothing in Lay suggests the underpressure has any gas-removal function or effect at the working gap.
Examiner’s Response #3:
The Examiner respectfully disagrees. The Applicant has argued the amount of underpressure in Lay is not strong enough to achieve the claimed degassing effect (prevention of bubbles) in order to reduce the risk of damaging the working film without any citations to, evidence from, or explanations of the prior art of record. Furthermore, applicant has not specifically pointed out some possible source of bubbles that would occur in Lay by citations, evidence or explanation of the prior art of record. As such, these statements are conclusory and Applicant’s remarks have been considered in accordance with MPEP 716.01[C] [“The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). As outlined in the rejections above, Lay does disclose a process and device for providing an amount of underpressure applied to the same location of the instant application. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process, and thus, the claimed property or function (i.e., prevents the formation of bubbles in the working gap), is necessarily present in the prior art material. [See MPEP 2112.02 (I)]. Additionally, the feature to which applicant argues [preventing bubbles] is an intended result of a positively recited step [“that prevents the formation of bubbles…” is the intended result of the positively recited step of providing an underpressure in an evacuation space]. The court noted that a '“whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat'l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). MPEP 2111.04(I).
Even so, Lay discloses, ". . .. if said digital microfluidics system 1 is equipped with suction holes 35 in the electrode array 9, and if the flexible bottom layer 3 is aspirated by said suction holes 35..." (Spec. [0060]) and "[0019] (e) a number of suction holes that penetrate the bottom substrate and the electrode array and that are distributed over the cartridge accommodation site of the base unit and over the waste hollow: [0020] (f) a vacuum source for establishing an underpressure in an evacuation space that is located between the electrode array or bottom Substrate and a disposable cartridge located thereon, and [0021] (g) a number of vacuum lines that link the suction holes to the vacuum source." One of ordinary skill in the art would recognize that Lay clearly wants to be able to evacuate any fluids/gases in the evacuation space 46. It is unclear why applicant argues that a number of vacuum suction lines would not remove bubbles from evacuation space 46 when applicant is also using vacuum lines that link the suction holes to the vacuum source.
Applicant argues that Lay’s underpressure acts in a different location. However, as outlined in the rejections of the independent claims above, Lay’s underpressure is in the same location as the instant application, (“providing an amount of underpressure in the cartridge accommodation site comprising substantially the same elements or components as that of the applicant and applied to the same location of the instant application, as taught by the instant specification (see specification page 16, lines 11-13, and see claims 2, 7, 9, and 10). Lay teaches providing an underpressure [which necessarily has an amount] in the evacuation space 46 inside the working gap 6 of the cartridge 2 by using a vacuum source 33 for establishing the underpressure in the evacuation space 46 that is located between the bottom substrate 11 (equivalent to the uppermost surface of the cartridge accommodation site 8) and the backside or bottom-most surface of the flexible working film 3, thus is an amount of underpressure in the cartridge accommodation site (Para. 0079, 0081 and Fig. 3).
Applicant further claims that Lay depicts bubble formation in Para. 0081. However, the examiner disagrees as Para. 0081 discloses “In such a digital microfluidics system 1, the flexible bottom layer 3 of the disposable cartridge 2 is preferably configured to be attracted by the underpressure in the evacuation space 46 and to be spread over the electrode array 9, the bottom substrate 11, and over the waste hollow 50 in the bottom substrate 11. In consequence, the flexible bottom layer 3 is sucked down into the depression or through hole in the bottom substrate 11. Thus, the flexible bottom layer 3 that defines the gap height 53 of the gap 6 between the bottom layer 3 and the top layer 4 of the disposable cartridge 6 also defines the area and height 51 of the waste hollow 50”. There is no mention no disclosure of bubble formation occurring in Lay, much less Para. 0081. Thus, the arguments are unpersuasive.
Applicant’s Argument #4:
Applicant argues on page 13 that Hafeman involves negative pressure in microchannels for reasons unrelated to electrowetting or flexible- film-mediated bubble suppression. Hafeman does not disclose or suggest applying negative pressure to a backside of a flexible film while the front side defines a droplet electrowetting working gap. Hafeman's disclosure of negative pressures between 0.1 psi and 3.0 psi bears no relationship to the structural and functional arrangement claimed here. The proposed modification of Lay using Hafeman would require a complete redesign of Lay's droplet-actuation geometry, again relying on hindsight.
Examiner’s Response #4:
The examiner respectfully disagrees. In response to applicant's arguments against the references individually (i.e., Hafeman not disclosing applying negative pressure to a backside of a flexible film while the front side defines a droplet electrowetting working gap) one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that Hafeman is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). The prior art of Hafeman et al. meets the above two conditions: (1) the reference is from the same field of endeavor, microfluidic devices [Abstract of Hafeman], as the claimed invention; and (2) the reference is reasonably pertinent to the problem faced by the inventor (i.e., reducing gas bubble formation within microfluidic channels [corresponding to a working gap], as bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125 of Hafeman]). Furthermore, "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. The Federal Circuit reads KSR as "direct[ing] us to construe the scope of analogous art broadly" because "familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle." [see MPEP 2141.01a]. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of underpressure in the cartridge accommodation site of Lay to be an amount between -0.1 psi and -3.0 psi so that bubbles are prevented from forming within the working gap/channel, as taught by Hafeman, of the cartridge of Lay, since Hafeman teaches it would be beneficial since bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125 of Hafeman].
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Hafeman teaches an application of a negative pressure i.e., a vacuum [corresponding to an underpressure], where the pressure (negative or positive) will be between e.g., 0.1 psi and 3.0 psi [thus teaching -0.1 psi and -3.0 psi since Hafeman discloses the pressure can be negative to reduce gas bubble formation [corresponding to bubbles are prevented from forming] within the channels [corresponding to a working gap], which is beneficial because bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125]. Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of underpressure in the cartridge accommodation site of Lay to be an amount between -0.1 psi and -3.0 psi so that bubbles are prevented from forming within the working gap/channel, as taught by Hafeman, of the cartridge of Lay, since Hafeman teaches it would be beneficial since bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices [Paras. 0083, 0109, 0100, 0125 of Hafeman]. Thus, applicant’s arguments regarding the proposed modification requiring a complete redesign, are unpersuasive. The modification above is based on only modifying the amount of underpressure [negative pressure] in vacuum, which is beneficial because bubbles may interrupt fluid flow within the channel and thus comprise operation of microfluidic devices, and would not require a complete redesign of Lay, who already discloses applying an amount of underpressure [negative pressure] with a vacuum source. Furthermore, the use of a known technique (i.e., an amount of negative pressure in vacuum that prevents gas bubble formation in a channel, taught by Hafeman) to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s Argument #5:
Applicant argues on page 13 that claim 2 requires the flexible working film to comprise a semi-permeable constitution with respect to gas and requires the application of underpressure specifically to an evacuation space located between the accommodation site's uppermost surface and the backside of that semi-permeable film. Lay does not disclose a film with any gas-permeable properties, does not disclose external gas removal, and does not disclose bubble prevention in the working gap through gas permeation. Because these limitations govern the film's structural nature and its interaction with the external underpressure source, and because neither Lay nor Adleff nor Hafeman teaches or suggests this arrangement, the rejection fails for independent claim 2 for the same reasons as for independent claim 1.
Examiner’s Response #5:
Based on the Examiner’s Responses #1-4 above, the independent claim 2 is still unpatentable over the prior art of the record. Therefore, the rejection is maintained of all claims.
The Examiner suggests applicant to further amend the independent claims to recite an underpressure in a range that does not overlap with the prior art of -0.1 psi to -3.0 psi, such as a claimed range of -4 to -6 psi, which appears to overcome the prior art of record.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOMMER OSMAN whose telephone number is (703)756-4790. The examiner can normally be reached Monday-Friday 8:30 - 5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.Y.O./Examiner, Art Unit 1794
/JAMES LIN/Supervisory Patent Examiner, Art Unit 1794
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