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 .
Claim Objections
Claims 2-4 are objected to because of the following informalities:
Regarding claims 2-4, there should be a comma after “The cartridge of claim 1”.
Regarding claim 2, the claim recites “mounted on a top plate” which should read “mounted on the top plate” since the term was already recited in the claim. Further, the claim recites “cartridges” which appears to be a typographical error which should read “cartridge”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “means for mounting the cartridge” in claim 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Regarding claim 11, the claim recites “means for mounting the cartridge” which uses the generic placeholder “means for” that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Accordingly, the limitation on “means for mounting the cartridge” is interpreted under 35 U.S.C. 112(f) as corresponding to the DMF interface for example, a pluggable interface for connecting mechanically and electrically to DMF cartridge 110 ([0033])
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 17-10 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 17-19, the claims recite the limitation "the illumination source" in line 1. There is insufficient antecedent basis for this limitation in these claims. For the purposes of examination, "the illumination source" is interpreted as “further comprising an illumination source”. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12313527 (hereinafter “’527”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the current application are broader in scope to the claims of the parent and are, therefore, fully anticipated by the parent claims.
Regarding claim 1, ‘527 discloses a cartridge for use with an instrument, (claim 1 line 1) the cartridge comprising:
digital microfluidics comprising a plurality of electrowetting electrodes operative to perform droplet operations on a liquid droplet in a droplet operations gap of the cartridge (claim 1 lines 3-6); and
a refractive index sensor exposed to the droplet operations gap in proximity with one or more of the electrowetting electrodes such that a droplet situated atop the one or more of the electrowetting electrodes will contact the refractive index sensor, an arrangement of the one or more of the electrowetting electrodes and the refractive index sensor establishing a droplet interrogation site (claim 1 lines 7-15).
Regarding claim 2, ‘527 discloses the cartridge of claim 1 wherein the cartridges comprises a top plate and the refractive index sensor is mounted on a top plate (claim 2).
Regarding claim 3, ‘527 discloses the cartridge of claim 1 wherein the refractive index sensor is mounted in the droplet operations gap (claim 3).
Regarding claim 4, ‘527 discloses the cartridge of claim 1 wherein the droplet operations gap is established by a top plate and a bottom plate in substantially parallel planes, and wherein the refractive index sensor is mounted in the droplet operations gap and has a sensor face that is at a right angle to the substantially parallel planes (claim 4).
Regarding claim 5, ‘527 discloses the cartridge of claim 1, wherein the refractive index sensor is provided as a tip of a waveguide (claim 5).
Regarding claim 6, ‘527 discloses the cartridge of claim 1, further comprising X or more refractive index sensing channels, where X≥2 (claim 6).
Regarding claim 7, ‘527 discloses the cartridge of claim 1, further comprising X or more optical fibers, where X≥2 (claim 7).
Regarding claim 8, ‘527 discloses the cartridge of claim 1, further comprising X or more refractive index sensing channels, where X≥10 (claim 8).
Regarding claim 9, ‘527 discloses the cartridge of claim 1, further comprising X or more refractive index sensing channels, where X≥50 (claim 8 X≥10 includes X≥50, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)). See MPEP 2144.05 Sec. I.).
Regarding claim 10, ‘527 discloses the cartridge of claim 1, further comprising a lens mounted opposite the refractive index sensor and droplet operations gap (claim 9)
Regarding claim 11, ‘527 discloses a system comprising: a cartridge according to claim 1; and an instrument comprising electronics for controlling the cartridge and a means for mounting the cartridge to effect electronic coupling and control (claim 10).
Regarding claim 12, ‘527 discloses the system of claim 11, further comprising one or more illumination sources configured to illuminate the droplet interrogation site or sites (claim 11).
Regarding claim 13, ‘527 discloses the system of claim 11, further comprising one or more optical measurement devices arranged to detect light from the droplet interrogation site or sites (claim 12).
Regarding claim 14, ‘527 discloses the system of claim 11, further comprising an illumination source and an optical measurement device arranged with respect to a droplet interrogation site to operate in transmission mode (claim 13).
Regarding claim 15, ‘527 discloses the system of claim 11, further comprising an illumination source and an optical measurement device arranged with respect to a droplet interrogation site to operate in reflection mode (claim 14).
Regarding claim 16, ‘527 discloses the system of claim 11, further comprising a scanning optical measurement device configured to scan multiple droplet interrogation sites (claim 15).
Regarding claim 17, ‘527 discloses the system of claim 11, wherein the illumination source is integrated into the cartridge (claim 16).
Regarding claim 18, ‘527 discloses the system of claim 11, wherein the illumination source comprises a light-emitting diode integrated into the cartridge (claim 17).
Regarding claim 19, ‘527 discloses the system of claim 11, wherein the illumination source comprises a coaxial illumination source (claim 18).
Regarding claim 20, 527 discloses a method, comprising: providing a system according to claim 11; loading a sample droplet into the droplet operations gap; conducting one or more sample processing steps on the sample droplet to yield an analysis-ready droplet; and conducting a refractive index analysis of analysis ready-droplet at a droplet interrogation site (claim 19).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over US20100118307A1 by Srinivasan et al. (hereinafter "Srinivasan") in view of JP2004163257A by Kenji et al. (hereinafter "Kenji").
Regarding claim 1, Srinivasan teaches a cartridge ([0005] droplet actuator device) for use with an instrument ([0005] device for determining the absorbance of a droplet), the cartridge comprising (at least Fig. 3):
digital microfluidics comprising a droplet actuator operative to perform droplet operations on a liquid droplet in a droplet operations gap of the cartridge ([0006] droplet actuator may include two substrates separated to form a gap, droplet positioned in the gap, [0042] gap 305; [0004] droplet operations performed by droplet actuator); and
a refractive index sensor ([0042] reflective region 301, according the applicant's specification, RI sensor, or sensor surface, means any methods of interrogating the RI of a droplet [0044], the claim does not require that the refractive index is measured) exposed to the droplet operations gap in proximity with the droplet actuator such that a droplet situated atop the droplet actuator will contact the refractive index sensor (Fig. 3; [0042] droplet in gap 305 on reflective region 301), an arrangement of the droplet actuator and the refractive index sensor establishing a droplet interrogation site (Fig. 3; droplet is interrogated by the light source and sensor at the site established by surface 301 and the bottom substrate 302)
Srinivasan does not explicitly teach digital microfluidics comprising a plurality of electrowetting electrodes and the refractive index sensor exposed to the droplet operations gap in proximity with one or more of the electrowetting electrodes such that a droplet situated atop the one or more of the electrowetting electrodes will contact the refractive index sensor, an arrangement of the one or more of the electrowetting electrodes and the refractive index sensor establishing a droplet interrogation site in this embodiment.
However, Srinivasan does address this limitation in another embodiment.
Srinivasan teaches the droplet actuator (digital microfluidics) may use electrowetting-based techniques ([0067]) and the droplet actuator typically includes a substrate associated with electrodes configured for conducting droplet operations thereof and may also include a second substrate arranged in a generally parallel fashion in relation to the droplet operations surface to form a gap in which droplet operations are effected. ([0004]). For example, the droplet may be controlled by electrowetting, one side of droplet may have an acute contact angle (wetting) while the other side is obtuse (nonwetting) ([0045]). Additionally, Fig. 9A shows an embodiment where the droplet actuator comprises a plurality of electrodes ([0056] electrodes 910).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use electrowetting-based techniques to control the droplet. Therefore, it would have been obvious to modify the first embodiment of Srinivasan to include the digital microfluidics comprising a plurality of electrowetting electrodes and the refractive index sensor exposed to the droplet operations gap in proximity with one or more of the electrowetting electrodes such that a droplet situated atop the one or more of the electrowetting electrodes will contact the refractive index sensor, an arrangement of the one or more of the electrowetting electrodes and the refractive index sensor establishing a droplet interrogation site in this embodiment in order to efficiently convey and manipulate the droplet using well-known techniques.
Further, even if Srinivasan does not explicitly teach a refractive index sensor, Srinivasan teaches determining from the sensed light energy an optical property of the droplet ([0006]), for example the concentration of a solution ([0037]) or absorbance ([0005]) by measuring the intensity of the light ([0037]).
Additionally, Kenji does address this limitation. Kenji and Srinivasan are considered to be analogous to the present invention as they are in the same field of optical investigation.
Kenji teaches that by measuring the refractive index of a fluid such as a solution or a gas in contact with the optical waveguide core, the characteristics of the sample, for example, the substance concentration can be measured ([0021]) by measuring the intensity of light ([0021]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to measure the refractive index of a droplet. Therefore, it would have been obvious to modify Srinivasan to explicitly include a refractive index sensor as suggested by Kenji in order to perform a more robust measurement.
Regarding claim 2, Srinivasan modified by Kenji teaches the cartridge of claim 1, and Srinivasan further teaches wherein the cartridges comprises a top plate ([0042] top surface 300) and the refractive index sensor is mounted on a top plate ([0042] Top surface 300 may include reflective region 301).
Regarding claim 3, Srinivasan modified by Kenji teaches the cartridge of claim 1, and Srinivasan further teaches wherein the refractive index sensor is mounted in the droplet operations gap (Fig. 3; [0042] reflective region 301 is a coating on surface 300 and thus mounted in the gap).
Regarding claim 4, Srinivasan modified by Kenji teaches the cartridge of claim 1, and Srinivasan further teaches wherein the droplet operations gap is established by a top plate (top surface 300; [0042]) and a bottom plate (bottom substrate 302; [0042]) in substantially parallel planes (Fig. 3), and wherein the refractive index sensor is mounted in the droplet operations gap (Fig. 3; [0042] reflective region 301 is a coating on surface 300 and thus mounted in the gap).
Srinivasan does not explicitly teach wherein the refractive index sensor has a sensor face that is at a right angle to the substantially parallel planes.
However, Srinivasan does teach this limitation in at least one separate embodiment.
Srinivasan teaches wherein the refractive index sensor has a sensor face that is at a right angle to the substantially parallel planes (Fig. 1, 5, 9, and 10B show configurations where the sensor face is at a right angle to the plates). For example, Fig 10B teaches sensor 1006 using optical fiber 1004 b, where the optical fiber acts as the sensor face ([0059]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to arrange the sensor face at a right angle. Further, it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. See MPEP 2144.04 Sec. V. C. Therefore, it would have been obvious to modify Srinivasan to include wherein the refractive index sensor has a sensor face that is at a right angle to the substantially parallel planes in this embodiment in order to arrange the device and transmit the light through the greater horizontal diameter of the droplet thus increasing the path-length for improved detection ([0037]-[0039]).
Regarding claim 5, Srinivasan modified by Kenji teaches the cartridge of claim 1, and although Srinivasan does not teach wherein the refractive index sensor is provided as a tip of a waveguide in this embodiment, Srinivasan does address this limitation in a separate embodiment.
Srinivasan teaches, in a separate embodiment, wherein the refractive index sensor is provided as a tip of a waveguide (Fig 10A teaches sensor 1006 using optical fiber 1004 b, where the optical fiber acts as the sensor face ([0059]). Additionally, various optical elements may be interposed between the light source and the droplet and/or between the droplet and the sensor, such as a waveguide ([0012]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a waveguide to direct light to a sensor.
Therefore, it would have been obvious to modify Srinivasan to include wherein the refractive index sensor is provided as a tip of a waveguide in this embodiment in order to efficiently transmit light to the detector.
Regarding claim 7, Srinivasan modified by Kenji teaches the cartridge of claim 1, and although Srinivasan does not teach further comprising X or more optical fibers, where X≥2 in this embodiment, Srinivasan does address this limitation in a separate embodiment.
Srinivasan teaches, in a separate embodiment, further comprising X or more optical fibers, where X≥2 (Fig. 10B, [0059] light from light source 1005 is transmitted to droplet 1003 using an optical fiber 1004 a and from droplet 1003 to detector or sensor 1006 using optical fiber 1004 b).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use optical fibers to direct light. Therefore, it would have been obvious to modify Srinivasan to include further comprising X or more optical fibers, where X≥2 in this embodiment in order to efficiently transmit light between the light source, droplet, and detector.
Claims 6, 8-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan in view of Kenji as applied to claim 1 above, and further in view of US20100045995A1 by Malic et al. (hereinafter "Malic").
Regarding claim 6, Srinivasan modified by Kenji teaches the cartridge of claim 1, but Srinivasan does not explicitly teach further comprising X or more refractive index sensing channels, where X≥2.
However, Malic does address this limitation. Malic and Srinivasan are considered to be analogous to the present invention as they are in the same field of microfluidics.
Malic teaches further comprising X or more refractive index sensing channels, where X≥2 ([0004] The support apparatus includes an SPR assembly having a metal electrode in electrical contact with a plurality of metal detection spots. Adjacent to each of the detection spots, a droplet of the fluid samples may be secured for subsequent SPR detection, according to the applicant's specification, DMF system may be SPR [0031] and the RI sensor may be SPR [0044]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to include multiple sensing channels. Further, it has been held that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) MPEP 2144.04 VI. Therefore, it would have been obvious to modify Srinivasan to include further comprising X or more refractive index sensing channels, where X≥2 in order to perform multiple simultaneous measurements, thus increasing efficiency ([0004]).
Regarding claim 8, Srinivasan modified by Kenji teaches the cartridge of claim 1, but Srinivasan does not explicitly teach further comprising X or more refractive index sensing channels, where X≥10.
However, Malic does address this limitation. Malic and Srinivasan are considered to be analogous to the present invention as they are in the same field of microfluidics.
Malic teaches further comprising X or more refractive index sensing channels, where X≥4 (Fig. 4; [0004] The support apparatus includes an SPR assembly having a metal electrode in electrical contact with a plurality of metal detection spots. Adjacent to each of the detection spots, a droplet of the fluid samples may be secured for subsequent SPR detection, according to the applicant's specification, DMF system may be SPR [0031] and the RI sensor may be SPR [0044]). Further, it has been held that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) MPEP 2144.04 VI.
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to include multiple sensing channels. Therefore, it would have been obvious to modify Srinivasan to include further comprising X or more refractive index sensing channels, where X≥10 in order to perform multiple simultaneous measurements, thus increasing efficiency ([0004]).
Regarding claim 9, Srinivasan modified by Kenji teaches the cartridge of claim 1, but Srinivasan does not explicitly teach further comprising X or more refractive index sensing channels, where X≥50.
However, Malic does address this limitation. Malic and Srinivasan are considered to be analogous to the present invention as they are in the same field of microfluidics.
Malic teaches further comprising X or more refractive index sensing channels, where X≥4 (Fig. 4; [0004] The support apparatus includes an SPR assembly having a metal electrode in electrical contact with a plurality of metal detection spots. Adjacent to each of the detection spots, a droplet of the fluid samples may be secured for subsequent SPR detection, according to the applicant's specification, DMF system may be SPR [0031] and the RI sensor may be SPR [0044]). Further, it has been held that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) MPEP 2144.04 VI.
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to include multiple sensing channels. Therefore, it would have been obvious to modify Srinivasan to include further comprising X or more refractive index sensing channels, where X≥50 in order to perform multiple simultaneous measurements, thus increasing efficiency ([0004]).
Regarding claim 11, Srinivasan modified by Kenji teaches a system comprising a cartridge according to claim 1, but Srinivasan does not explicitly teach further the system comprising an instrument comprising electronics for controlling the cartridge and a means for mounting the cartridge to effect electronic coupling and control.
However, Malic does address this limitation. Malic and Srinivasan are considered to be analogous to the present invention as they are in the same field of microfluidics.
Malic teaches an instrument (Fig. 7; conventional SPR apparatus may be carried out to accommodate an EWOD (electrowetting-on-dielectric) digital microfluidic platform ) comprising electronics for controlling the cartridge (electronic interface 72; [0037]; [0024] standard EWOD control technology) and a means for mounting the cartridge to effect electronic coupling and control ([0037] chip holder and electronic interface 72).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use the cartridge with a control instrument, Therefore, it would have been obvious to modify Srinivasan to include an instrument comprising electronics for controlling the cartridge and a means for mounting the cartridge to effect electronic coupling and control as suggested by Malic in order to use well-known structures to efficiently use the cartridge for sample analysis.
Regarding claim 12, Srinivasan modified by Kenji and Malic teaches the system of claim 11, and Srinivasan further teaches comprising one or more illumination sources configured to illuminate the droplet interrogation site or sites ([0042] light source 303).
Regarding claim 13, Srinivasan modified by Kenji and Malic teaches the system of claim 11, and Srinivasan further teaches comprising one or more optical measurement devices arranged to detect light from the droplet interrogation site or sites ([0042] sensor 304).
Regarding claim 14, Srinivasan modified by Kenji and Malic teaches the system of claim 11, and Srinivasan further teaches comprising an illumination source and an optical measurement device arranged with respect to a droplet interrogation site ([0037] light source 303, sensor 304).
Although Srinivasan does not teach to operate in transmission mode in this embodiment, Srinivasan does address this limitation in at least one separate embodiment.
Srinivasan teaches to operate in transmission mode (Fig. 1; 2A, 2B, 6, 10A, 10B, and 11; [0039] light from light source 103 passes through droplet 101 to detector or sensor 104).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to operate the device in transmission mode. Therefore, it would have been obvious to modify Srinivasan to include to operate in transmission mode in this embodiment in order to transmit the light through the greater horizontal diameter of the droplet thus increasing the path-length for improved detection ([0037]-[0039]).
Regarding claim 15, Srinivasan modified by Kenji and Malic teaches the system of claim 11, and Srinivasan further teaches comprising an illumination source and an optical measurement device arranged with respect to a droplet interrogation site to operate in reflection mode (Fig. 3; [0042] light transmitted by light source 303 is reflected off of reflective region 301 and detected by sensor 304, note alternatively reflective region 301 may be the bottom surface).
Regarding claim 16, Srinivasan modified by Kenji and Malic teaches the system of claim 11, but Srinivasan is silent as to further comprising a scanning optical measurement device configured to scan multiple droplet interrogation sites.
However, Malic does address this limitation.
Malic teaches a scanning optical measurement device configured to scan multiple droplet interrogation sites (Fig. 1; [0017] an SPR beam source 16 and a CCD array 18 used to scan detection spots 26; [0020]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a scanning optical system. Therefore, it would have been obvious to modify Srinivasan to include a scanning optical measurement device configured to scan multiple droplet interrogation sites as suggested by Malic in order to perform multiple simultaneous measurements, thus increasing efficiency ([0004]).
Regarding claim 17, Srinivasan modified by Kenji and Malic teaches the system of claim 11, and although Srinivasan teaches an illumination source ([0042] light source 303), Srinivasan is silent as to wherein the illumination source is integrated into the cartridge. However, it has been held that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) See MPEP 2144.04 V.
It would have been well known and obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Srinivasan to integrate the illumination source into the cartridge in order to provide a simpler, more compact one piece construction.
Regarding claim 18, Srinivasan modified by Kenji and Malic teaches the system of claim 11, and Srinivasan further teaches an illumination source ([0042] light source 303) comprises a light-emitting diode ([0066] light source may be LED).
Srinivasan is silent as to wherein the illumination source is integrated into the cartridge. However, it has been held that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) See MPEP 2144.04 V.
It would have been well known and obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Srinivasan to integrate the illumination source into the cartridge in order to provide a simpler, more compact one piece construction.
Regarding claim 19, Srinivasan modified by Kenji and Malic teaches the system of claim 11, and Srinivasan further teaches wherein the illumination source comprises a coaxial illumination source ([0042] Fig. 3 shows light source 303 on same side of RI sensor as detector 304 which is described as coaxial illumination by applicant's specification [0071]).
Regarding claim 20, Srinivasan modified by Kenji and Malic teaches the system of claim 11, and Srinivasan further teaches a method, comprising:
providing a system according to claim 11 (see claim 11);
loading a sample droplet into the droplet operations gap ([0021] loading a droplet into the droplet actuator);
conducting one or more sample processing steps on the sample droplet to yield an analysis-ready droplet ([0021] for example, mixing, agitating, deforming, heating, etc); and
conducting analysis of analysis ready-droplet at a droplet interrogation site ([0037] Characteristics of the light energy emitted from the droplet may be detected and analyzed, for example concentration).
Srinivasan does not explicitly teach conducting a refractive index analysis.
However, Kenji does address this limitation.
Kenji teaches that by measuring the refractive index of a fluid such as a solution or a gas in contact with the optical waveguide core, the characteristics of the sample, for example, the substance concentration can be measured ([0021]) by measuring the intensity of light ([0021]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to measure the refractive index of a droplet. Therefore, it would have been obvious to modify Srinivasan to explicitly include conducting a refractive index analysis as suggested by Kenji in order to perform a more robust measurement.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan in view of Kenji as applied to claim 1 above, and further in view of US20050239210A1 by Iida.
Regarding claim 10, Srinivasan modified by Kenji teaches the cartridge of claim 1, but Srinivasan is silent as to further comprising a lens mounted opposite the refractive index sensor and droplet operations gap.
However, Srinivasan teaches an embodiment (Fig. 8) where the electrode itself may be optics such as lenses ([0055]) and various optical elements may be interposed between the light source and the droplet and/or between the droplet and the sensor ([0012]).
Further, Iida does address this limitation. Iida and Srinivasan are considered to be analogous to the present invention as they are in the same field of microfluidics.
Iida teaches a lens (lens 207) mounted opposite the refractive index sensor (transparent coating 206) and droplet operations gap (channel 203 or gap in Fig. 2B; [0125]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a lens in a microfluidics system. Therefore, it would have been obvious to modify Srinivasan to include a lens mounted opposite the refractive index sensor and droplet operations gap as suggested by Iida in order to improve detection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2019236682 A1 by Jagtiani teaches cartridges and devices for operating said cartridges for analyzing a biological sample and incudes electrowetting electrodes ([00164] The device can interface with the cartridge as a system to analyze the biological sample).
US 20130224886 A1 by Iwasaki teaches a flow rate measurement apparatus with a prism (Fig. 1 prism 104)
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/KAITLYN E KIDWELL/Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877
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