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 .
Response to Amendment
The amendments and remarks, filed on 12/21/2025, has been entered. The previous prior art rejection is stands and is applied to address the claim amendments.
Claim Status
Claims 1-3, 5-12, 14 and 16-23 are pending with claims 1-3, 5, 7-8, and 16-23 are being examined and claims 6, 9-12, and 14 are withdrawn.
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 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 1-3, 5, 7-8, 16-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al (US 20050012197 A1; hereinafter “Smith”; already of record) in view of Chong et al (US 20080199362 A1; hereinafter “Chong”) in view of Schembri (US 20040087008 A1; hereinafter “Schembri”; already of record).
Regarding claim 1, Smith teaches a multizonal microfluidic device (Smith; Abstract; MEMs package), comprising:
a substrate (Smith; Fig. 1; para [15]; a substrate 3);
a first lid mounted to the substrate (Smith; Fig. 1; para [15]; A primary face 21 (FIG. 3) of the cover plate 2 is attached to a primary surface 31 of the substrate by a bond ring 4; the examiner interprets the lid to comprise the cover plate and the bond ring) and forming a first microfluidic chamber between structures including a first interior surface of the first lid and a first discrete portion of the substrate (Smith; Fig. 3; para [17]; the primary surface 31 of the substrate 3, the primary face 21 of the cover plate 2 and the bond ring 4 define an inner cavity 11), the first lid comprising a first inlet and a first vent positioned relative to one another to facilitate loading of fluid to the first microfluidic chamber via capillary action (Smith; Fig. 1; para [33]; the bond ring 4 has two breaches 42 a, 42 b which define a fill port 111 a and an evacuate port 111 b)1;
a first microchip mounted to the substrate (Smith; Fig. 1, 4; para [15]; The substrate 3 may be a silicon substrate and may have a MEMS structure 32 fabricated on the primary surface 31), wherein a portion of the first microchip is positioned within and extending through the first microfluidic chamber (Smith; Fig. 1, 4; examiner notes that the microchip interpreted as the MEMS structure 32 is seen to be positioned within the microfluidic chamber) with an entire perimeter of an entire length of the first microchip facing space within the first microfluidic chamber (Smith; Fig. 3; the examiner notes that the top of the microchip faces the interior of the microfluidic chamber);
a second lid2 mounted to the substrate (Smith; Fig. 1; para [15]; A primary face 21 (FIG. 3) of the cover plate 2 is attached to a primary surface 31 of the substrate by a bond ring 4; the examiner interprets the lid to comprise the cover plate and the bond ring) and forming a second microfluidic chamber2 between structures including a second interior surface of the second lid and a second discrete portion of the substrate (Smith; Fig. 3; para [17]; the primary surface 31 of the substrate 3, the primary face 21 of the cover plate 2 and the bond ring 4 define an inner cavity 11), the second lid comprising a second inlet and a second vent2 positioned relative to one another to facilitate loading of fluid to the second microfluidic chamber via capillary action (Smith; Fig. 1; para [33]; the bond ring 4 has two breaches 42 a, 42 b which define a fill port 111 a and an evacuate port 111 b); and
a second microchip2 mounted to the substrate (Smith; Fig. 1, 4; para [15]; The substrate 3 may be a silicon substrate and may have a MEMS structure 32 fabricated on the primary surface 31), wherein a portion of the second microchip is positioned within and extending through the second microfluidic chamber (Smith; Fig. 1, 4; examiner notes that the microchip interpreted as the MEMS structure 32 is seen to be positioned within the microfluidic chamber) with an entire perimeter of an entire length of the second microchip facing space within the second microfluidic chamber (Smith; Fig. 3; the examiner notes that the top of the microchip faces the interior of the microfluidic chamber).
2 Examiner notes that the structures recited as a second lid, a second microfluidic chamber, a second inlet, a second vent, and a second microchip is disclosed by Smith. Specifically, Smith teaches a plurality of MEMS structures 32 on the substrate to form a MEMS assembly 100 (Smith; Fig. 5; para [19]). Thus, the citations above apply to a separate MEMS structure as seen in Figure 5.
Smith does not teach the first microchip directly contacts the first lid and forms a fluid seal with the first lid, and the second microchip directly contacts the second lid and forms a fluid seal with the second lid.
However, Chong teaches an analogous art of a microfluidics package (Chong; Abstract) comprising a substrate (Chong; Fig. 4, 5; para [71]; A substrate 6); a lid mounted to the substrate (Chong; Fig. 4, 5; para [72]; cover 14) and forming a microfluidic chamber between structures including an interior surface of the lid and a discrete portion of the substrate (Chong; Fig. 4, 5; para [74]; A tubing is inserted via inlet port 16 into the top cover 14 in order to access fluidic channels 11,12 in the substrate 6); a microchip mounted to the substrate (Chong; Fig. 4, 5; para [72]; fluidic chip 2) wherein a portion of the microchip is positioned within and extending through the microfluidic chamber to contact and form a fluid seal with the lid (Chong; Fig. 4, 5; para [72]; The cover 14 is placed over the fluidic chips 2 in order to better secure the fluidic chips 2 and to seal of the region of the fluidic chips 2, from the surrounding environment). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have modified the first microchip and the second microchip of Smith to directly contact the first lid and second lid as taught by Chong, because Chong teaches that cover is placed over the fluidic chips in order to better secure the fluidic chip and seal the regions from the surrounding environment (Chong; para [72]). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to arrange the microchip of Smith in the manner of ----being positioned in the lid as taught by Chong as this is a known and suitable arrangement for the microchip in the art. Further, it is a matter of engineering design to arrange the ----microchip in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Finally, one would have a reasonable expectation of success by changing the arrangement of the microchip to the claimed limitation as Chong teaches this arrangement is a known and suitable arrangement in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A).
Modified Smith does not teach wherein the first microchip and the second microchip are both elongated microchips and independently have a width to length aspect ratio from 1:10 to 1:150.
However, Schembri teaches an analogous art of microfluidic device on a flexible substrate (Schembri; para [15]) comprising a first microchip and a second microchip (Schembri; Fig. 8A; para [133]; arrays 112) wherein the first microchip and the second microchip are both elongated microchips and independently have a width to length aspect ratio from 1:10 to 1:150 (Schembri; para [47]; The arrays 112 will typically be arranged end to end along the lengthwise direction of flexible support 110…flexible support 110 may be at least 100 cm (or at least 200 or 500 cm) in length… a width, for example, of less than 100 cm, or even less than 50, 30, 10, 5, 1, 0.5, or 0.3 cm…ratio of the number of arrays 112 positioned lengthwise along flexible support 110 to the number across the width may be at least 10/1). Examiner notes that the width to length aspect ratio of the first and second microchip is dependent on the number of arrays present on the flexible substrate. For example, a flexible support with a length of 500 cm and 5 cm wide, with 10 arrays present would result in an aspect ratio of 1:10 as each array would be 50 cm long. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum width, length, and array number to result in a width to length aspect ratio in the range of 1:10 to 1:150 which allow for multiple test (Schembri; para [48]). See MPEP 2144.05(III).
Regarding claim 2, modified Smith teaches the multizonal microfluidic device of claim 1 (Chong is modified to comprise the plurality of separate microchip structures as taught by Smith discussed above in claim 1), further comprising from 1 to 100 additional microchips mounted to the substrate (Smith; Fig. 5; para [19]; a plurality of cover plates 2 may attached to a substrate 300 with a plurality of MEMS structures 32).
Regarding claim 3, modified Smith teaches the multizonal microfluidic device of claim 2, further comprising from 1 to 100 additional lids mounted to the substrate to form multiple microfluidic chambers that contain portions of the additional microchips (Smith; Fig. 5; para [19]; a plurality of cover plates 2 may attached to a substrate 300 with a plurality of MEMS structures 32).
Regarding claim 5, modified Smith teaches the multizonal microfluidic device of claim 1, wherein the first microfluidic chamber contains a single microchip portion, which is the portion of the first microchip, and wherein the second microfluidic chamber contains a single microchip portion, which is the portion of the second microchip (Smith; Fig. 5; para [19]; a plurality of cover plates 2 may attached to a substrate 300 with a plurality of MEMS structures 32).
Regarding claim 7, modified Smith teaches the multizonal microfluidic device of claim 1, wherein the first microchip is independently addressable with respect to a parameter relative to the second microchip (Smith; Fig. 5; para [36]; a plurality of inner cavities defined on a wafer may be filled with fluid). Examiner notes that each MEMS device comprises a separate cavity, thus capable of addressing different parameters.
Regarding claim 8, modified Smith teaches the multizonal microfluidic device of claim 1, with the first microfluidic chamber and the second microfluidic chamber.
Modified Smith does not teach wherein the first microfluidic chamber and the second microfluidic chamber independently have an individual volume from 50 pl to 10 µl.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum volume to result in an individual volume from 50 pl to 10 µl, because the volume of the fluid contained within the inner cavity is sufficiently small so that the change in volume upon expansion is sufficiently small to be accommodated by a slight deflections of the cover plate, substrate, bond ring, adhesive seal, thereby reducing the risk of damage to the cover plate (Smith; para [35]). See MPEP 2144.05(III).
Regarding claim 16, modified Smith teaches the multizonal microfluidic device of claim 1, the first microchip having a first set of one or more functional components, and the second microchip having a second set of one or more functional components that is different from the first set of functional components (see claim 1). Examiner interprets that there is the one microchip and the second microchip, and since the microchips are separate structures, with different functional components they are not the same structure. Examiner notes that “functional components” can be interpreted as any structure providing a function, thus the channels, the inlet ports, the lids, or the vents are interpreted as the set of functional components.
Regarding claim 17, modified Smith teaches the multizonal microfluidic device of claim 1, with the first microchip and the second microchip.
Modified Smith does not teach wherein each of the first microchip and the second microchip includes at least one of a heater, a sensor, an electromagnetic radiation source, a fluid actuator, a mixer, a bubbler, a valve, or a fluid pump.
However, Schembri teaches an analogous art of microfluidic device on a flexible substrate (Schembri; para [15]) comprising a first microchip and a second microchip (Schembri; Fig. 8A; para [133]; arrays 112) including at least one of a heater, a sensor, an electromagnetic radiation source, a fluid actuator, a mixer, a bubbler, a valve, or a fluid pump (Schembri; para [116]; the integrated device includes electrical, photo, physical, or chemical sensors in electrical communication with the electronic component via conductive elements in or on the component substrate). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the first microchip and the second microchip of modified Smith each comprise a sensor as taught by Schembri, because Schembri taches that the sensors detect a signal resulting from a corresponding target from the fluid of interest (Schembri; para [116]).
Regarding claim 18, modified Smith teaches the multizonal microfluidic device of claim 1, with the first microchip and the second microchip.
Modified Smith does not teach wherein the first microchip includes a first sensor, and the second microchip includes a second sensor that is different from the first sensor.
However, Schembri teaches an analogous art of microfluidic device on a flexible substrate (Schembri; para [15]) comprising a first microchip and a second microchip (Schembri; Fig. 8A; para [133]; arrays 112) wherein the first microchip includes a first sensor, and the second microchip includes a second sensor that is different from the first sensor (Schembri; para [116]; the integrated device includes electrical, photo, physical, or chemical sensors in electrical communication with the electronic component via conductive elements in or on the component substrate). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the first microchip and the second microchip of modified Smith each comprise a sensor as taught by Schembri, because Schembri taches that the sensors detect a signal resulting from a corresponding target from the fluid of interest (Schembri; para [116]). Examiner interprets that there is the one microchip and the second microchip, and since the microchips are separate structures, the modification for each microchip to comprise the sensor would not be the same sensor.
Regarding claim 19, modified Smith teaches the multizonal microfluidic device of claim 1, with the first microchip and the second microchip.
Modified Smith does not teach wherein the first microchip includes a first temperature regulator and a first sensor, and the second microchip includes a second temperature regulator and a second sensor that is different from the first sensor.
However, Schembri teaches an analogous art of microfluidic device on a flexible substrate (Schembri; para [15]) comprising a first microchip and a second microchip (Schembri; Fig. 8A; para [133]; arrays 112) wherein the first microchip includes a first temperature regulator and a first sensor, and the second microchip includes a second temperature regulator and a second sensor that is different from the first sensor (Schembri; para [108, 116]; the microfluidic component may include control circuitry which may, for example, provide voltage control, current control, temperature control…the integrated device includes electrical, photo, physical, or chemical sensors in electrical communication with the electronic component via conductive elements in or on the component substrate). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the first microchip and the second microchip of modified Smith to each comprise the sensor as taught by Schembri, because Schembri taches that the sensors detect a signal resulting from a corresponding target from the fluid of interest (Schembri; para [116]). Further, it would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the first microchip and the second microchip of Smith to each comprise the temperature regulator as taught by Schembri, because Schembri teaches temperature component adjusts the temperature of the monitored region to the desired temperature (Schembri; para [120]). Examiner interprets that there is the one microchip and the second microchip, and since the microchips are separate structures, the modification for each microchip to comprise the sensor and the temperature regulator would not be the same sensor and temperature regulator.
Regarding claim 20, modified Smith teaches the multizonal microfluidic device of claim 1, wherein the first lid is formed of a first material and the second lid is formed of a second material that is different from the first material (Smith; para [15]; the cover plate 2 may be an optical window or aperture and may comprise silicon, glass, plastic, metal or metal alloys). Examiner notes that Smith teaches different compositions for the cover plate, and the cover plate for one MEMS device can be different from another.
Regarding claim 21, modified Smith teaches the multizonal microfluidic device of claim 1, wherein the first lid is optically transparent or translucent, and the second lid is optically opaque (Smith; para [15]; the cover plate 2 may be an optical window or aperture and may comprise silicon, glass, plastic, metal or metal alloys). Examiner notes that Smith teaches different compositions for the cover plate, and the cover plate for one MEMS device can be different from another.
Regarding claim 23, modified Smith teaches the multizonal microfluidic device of claim 1 (the first microchip and the second microchip of Smith is modified to directly contact the lid as taught by Chong discussed above in claim 1), wherein the first microchip forms the fluid seal with the first lid by extending through the first microfluidic chamber and directly against the first lid (Chong; Fig. 4, 5; para [72]; The cover 14 is placed over the fluidic chips 2 in order to better secure the fluidic chips 2 and to seal of the region of the fluidic chips 2, from the surrounding environment).
Allowable Subject Matter
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of Smith in view of Chong in view of Schembri fails to disclose “wherein the first microchip forms the fluid seal with the first lid by extending from a floor of the first microfluidic chamber, through the first lid, and out of the first microfluidic chamber, the fluid seal formed at a contacting point between a bottom of the first lid and a top of the first microchip”. Specifically, the microchip of Smith is modified to be arranged within the lid as taught by Chong. The resulting modification would not be operable to form the fluid seal with the first lid by extending from a floor of the first microfluidic chamber.
Response to Arguments
Applicant’s arguments filed, 12/21/2025, have been considered and the arguments are found to be persuasive. The non-persuasive arguments are addressed below.
In the Applicant’s arguments, on page 8-9, the Applicant argues that amended claim 1 is not taught by Smith in view of Chong in view of Schembri. The examiner respectfully disagrees. Smith teaches an entire perimeter of an entire length of the first/second microchip facing space within the first/second microfluidic chamber (Smith; Fig. 3; the examiner notes that the top of the microchip faces the interior of the microfluidic chamber). The Examiner notes that Applicants arguments are directed to Chong failing to teach the amendments. However, the Examiner does not rely on Chong to teach the new limitation, but rather relies on Chong the microchip directly contacts the lid. The microchip is modified to be positioned in the lid as taught by Chong as seen in Fig. 4. However, this does not change the microfluidic chamber of Smith, and the microchip is simply rearranged as discussed above in claim 1. In response to applicant's arguments against the references individually, 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 the Applicant’s arguments, on page 9-10, the Applicant argues that claim 22 has a separate basis for patentability. The examiner agrees and is indicated above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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, Duane Smith can be reached at (571)272-1116. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796 /DUANE SMITH/ Supervisory Patent Examiner, Art Unit 1759