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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 03/30/2026 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 30 March 2026.
Claims 1, 3-5, 7-9, and 11-22 are pending.
Claims 2, 6, and 10 are cancelled.
Claims 8-9, 11-20, and 22 are withdrawn.
No claims are newly added.
Claims 1 and 3 are amended.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Link et al. (US 2014/0305799 A1), hereinafter “Link”.
Regarding Claim 1, Link teaches a microfluidic chip comprising:
a body ([0096]: “…the fluid channels may be formed in part by a single component (e.g. an etched substrate or molded unit).”); and
a plurality of microfluidic networks ([0126]) defined by the body, each of the microfluidic networks including:
one or more ports 721/722/725 ([0055]: “Liquid carrier 705 is introduced into fluidic network 710 through inlet 725, while first fluid 701 is introduced through inlet 721, and second fluid 702 is introduced through inlet 722.”);
a test volume 717 that is in fluid communication with each of the port(s) 721/722/725 (Fig. 14B shows a serpentine channel forming a test volume. It is further noted that the “test volume” is merely a nominal volume and any volume of the device capable of performing a test is considered a test volume.);
one or more channels 706, each in fluid communication between at least one of the port(s) 721/722/725 and the test volume 717 (Fig. 14B shows the channel 706 as in fluid communication with the test volume 717 and each of the ports 721/722/725.); and
one or more droplet-generating regions, each in fluid communication between at least one of the port(s) 721/722/725 and the test volume 717 ([0111]: “By incorporating the forces that result from charging the aqueous fluid in an electric field, E, smaller droplets are produced with more precise control of their individual timing than is feasible with other strategies that rely solely on viscous forces to overcome surface tension; this provides a robust droplet generation module that allows the production of microreactors with volumes as small as femtoliters.” – See also para. [0055] which discusses droplet generation in the device shown in Fig. 14B, the assembly being interpreted as a droplet generator region. – Examiner further notes that these droplet-generating regions as claimed herein are merely regions of empty space.);
wherein at least one of the droplet-generating region(s) includes an expansion region configured to produce droplets (Fig. 14B shows inlets 721 and 722 feeding a sample liquid and a spacer liquid to a channel 706 to produce droplets. The space of the common channel 706 therebetween the outlets of the channels of said inlets is interpreted as an expansion region of the droplet generating region, each sample droplet expanding in this region before being separated by the spacer liquid. Further, as seen through Fig. 3A, the space between the fluid sources 10 and 110 may be interpreted as an expansion region given that the “expansion region” is recited as a mere region of space with the nominal “expansion” designator not adding any particular structure thereto. See also Fig. 12D and [0070]: “…droplet 76 passes through one or more expansion regions 77 within a channel, causing the fluids within droplet 76 to be at least partially mixed, resulting in droplet 79.”);
wherein:
the one or more ports consist of a single port; OR
the one or more ports 721/722/725 comprise two or more ports and the microfluidic network is configured such that each of the two or more ports 721/722/725 is arranged such that fluid is permitted to flow from the port to each other of the two or more ports without flowing through the test volume 717 (Fig. 14B shows each of the ports 721/722/725 as connected via the channel 706, which provides a fluid connection allowing fluid to pass between each of the ports without passing through the test volume.);
as in Claim 1.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Link teaches the microfluidic chip discussed above wherein each of the channel(s) has a maximum transverse dimension, taken perpendicularly to a centerline of the channel, that is less than 2 millimeters (mm) ([0098]), as in Claim 4.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 4, 7, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Link. Link has been discussed above.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further as the maximum flow rate through the chip is a property that can be modified by adjusting the diameter of the channel, as understood through basic fluid principles, the precise channel diameter would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed channel diameter of less than 2 mm cannot be considered critical. Thus, one of ordinary skill in the art would have optimized through routine experimentation the channel diameter to maximally obtain the desired flow rate (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Link teaches the microfluidic chip discussed above wherein the expansion portion has:
a constant portion and an expanding portion such that liquid is permitted to exit the portion of the network into the constant portion and flow to the expanding portion, wherein: the constant portion has a height that is substantially the same between the portion of the network and the expanding portion and is substantially equal to the minimum height of the expansion region (Fig. 12D shows constant portions to the left and right of the two expansion regions 77. Herein, the constant portion is shown as having a height that is substantially the same between the portion of the network and the expanding portion and is substantially equal to the minimum height of the expansion region.); and
the expanding portion has a height that increases moving away from the constant portion (Fig. 12D shows the expanding portion has a height that increases moving away from the constant portion.),
and the expansion region exits toward the test volume ([0070, 0077]),
as in Claim 7.
Further regarding Claim 7, Link does not specifically teach the microfluidic chip discussed above wherein the expansion region has: a minimum height that is greater than or equal to 150% of a maximum height of a portion of the network, as in Claim .
However, as droplet size and mixing factor are properties that can be modified by adjusting the change in height of an expansion region of the device, as evidenced through Schewmmer (Fig. 5c and [0019]), the precise relative height of the expansion region would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the relative 150% height of the expansion region cannot be considered critical. Thus, one of ordinary skill in the art would have optimized through routine experimentation the relative height of the expansion region to maximally obtain the desired properties of droplet size and mixing (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 21, the prior art meets the limitations of Claim 1 as discussed above. Further, Link does not specifically teach the microfluidic chip discussed above wherein:
a minimum height of the expansion region is greater than or equal to 150% of a maximum height of a portion of the network that exits into the expansion region in a direction toward the test volume; and
a maximum height of the expansion region and a maximum height of the test volume are each between 15 and 120 um, as in Claim 21.
However, regarding the height of the expansion region is greater than or equal to 150% of the network: As droplet size and mixing factor are properties that can be modified by adjusting the change in height of an expansion region of the device, as evidenced through Schewmmer (Fig. 5c and [0019]), the precise relative height of the expansion region would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the relative 150% height of the expansion region cannot be considered critical. Thus, one of ordinary skill in the art would have optimized through routine experimentation the relative height of the expansion region to maximally obtain the desired properties of droplet size and mixing (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Further, regarding a maximum height of the expansion region and a maximum height of the test volume are each between 15 and 120 um, mere change in size (where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device) absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed size is an obvious matter of design choice – see MPEP 2144.04(IV)(A).
Herein, one of ordinary skill in the art would find it obvious to provide the device with a maximum height of the expansion region and a maximum height of the test volume are each between 15 and 120 um, as in Claim 21, so as to provide sufficiently sized microfluidic channels for holding droplets, the integrity of which depending on channel size; and would have a reasonable expectation of success therein.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Link in view of Blackburn (US 2005/0009101 A1), hereinafter “Blackburn”. Link has been discussed above.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Link does not specifically teach the microfluidic chip discussed above wherein for each of the ports:
the port has a minimum cross-sectional area, taken perpendicularly to a centerline of the port; and for each of the channel(s) connected to the port, the portion of the channel that connects to the port has a minimum cross-sectional area, taken perpendicularly to the centerline of the portion of the channel, that is less than or equal to 90% of the minimum cross-sectional area of the port, as in Claim 3.
However, Blackburn teaches a respective microfluidic device wherein the portion of the channel that connects to the port has a minimum cross-sectional area, taken perpendicularly to the centerline of the portion of the channel, that is less than or equal to the minimum cross-sectional area of the port (Fig. 35 and [0410]: “Input and output ports 19 and 20 are preferably shaped to accept a plastic pipette tip, most preferably a 10 μL pipette tip or a 200 μL pipette tip. In preferred embodiments, input and output ports 19 and 20 are generally in the shape of a truncated cone, as shown in FIG. 35, wherein the end of the cone having the smaller diameter forms the first opening of each port 29 and 31, respectively, and the end of the cone having the larger diameter forms the second opening of each port 30 and 32, respectively.”), wherein this structure provides for a fluid-tight seal between the microfluidic chip and a fluidic feeder mechanism connected thereto. Further, para. [0410] teaches the minimum cross-sectional area, taken perpendicularly to the centerline of the portion of the channel, that is less than or equal to 90% of the minimum cross-sectional area of the port ([0410]: “…each port preferably has a diameter on second substrate surface 13 of from about 1.0 mm to about 2.0 mm, and a diameter on first substrate surface 12 of from about 0.3 mm to about 0.6 mm. The conical walls of ports 19 and 20 form an angle 54 with the second substrate surface 13…”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Link wherein for each of the ports: the port has a minimum cross-sectional area, taken perpendicularly to the centerline of the port; and for each of the channel(s) connected to the port, the portion of the channel that connects to the port has a minimum cross-sectional area, taken perpendicularly to the centerline of the portion of the channel, that is less than or equal to 90% of the minimum cross-sectional area of the port, such as suggested by Blackburn, so as to provide a sufficient structure for providing a fluid-tight seal between the microfluidic chip and a fluidic feeder mechanism connected thereto; and would have a reasonable expectation of success therein.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Link in view of Wilkswo et al. (US 2015/0004077 A1), hereinafter “Wilkswo”. Link has been discussed above.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Link teaches the microfluidic chip discussed above wherein the body comprises:
a planar portion having top and bottom faces connected by an edge, the planar portion defining the test volume 717 and the channel(s) 706 of each of the microfluidic networks (Figs. 14A-B show the microfluidic device as planar with top and bottom faces connected by an edge and a test volume 717 contained therebetween.), as in Claim 5.
Further regarding Claim 5, Link does not specifically teach the microfluidic chip discussed above wherein for each of the microfluidic networks, one or more protrusions extending from the top face, each of the protrusion(s) defining at least a portion of at least one of the port(s) of one of the microfluidic networks, as in Claim 5.
However, Wikswo teaches a respective microfluidic chip comprising ports having luer-type fittings extending therefrom (Figs. 23 and 25, and [0205]), wherein this arrangement gives a sufficient structure for providing a fluid-tight seal between the microfluidic chip and feed lines connected thereto.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microfluidic chip of Link wherein for each of the microfluidic networks, one or more protrusions extending from the top face, each of the protrusion(s) defining at least a portion of at least one of the port(s) of one of the microfluidic networks, such as suggested by Wilkswo, so as to provide a fluid-tight seal between the microfluidic chip and feed lines connected thereto; and would have a reasonable expectation of success therein.
Response to Arguments
35 USC 112
Applicant’s amendments sufficiently overcome the 35 USC 112b rejection of Claim 3 set forth by the previous office action; as such, that rejection of Claim 3 is withdrawn.
35 USC 102
Applicant’s arguments are on the alleged grounds that Link does not teach the amended Claim 1 recitation requiring that the expansion region be configured to produce droplets, the expansion regions of Link instead being aimed toward droplet mixing.
Applicant’s arguments are not persuasive because Applicant’s amendments necessitated the new interpretation of “expansion region” as being seen through Fig. 14B showing inlets 721 and 722 feeding a sample liquid and a spacer liquid to a channel 706 to produce droplets. The space of the common channel 706 therebetween the outlets of the channels of said inlets is interpreted as an expansion region of the droplet generating region, each sample droplet expanding in this region before being separated by the spacer liquid.
Applicant has not provided any particular structure to the term “expansion region” wherein the “expansion” portion is a mere nominal designation to a generic region of the device. As such, any arbitrary region of the droplet generating region may be interpreted as an expansion region configured to produce droplets as the entirety of the droplet generating region itself is configured to produce droplets. – Applicant may wish to claim the particular structure constituting the expansion region, such as a channel taper or change in size, or the particular droplet-producing channel arrangement if the “expansion” refers to function of expanding a droplet rather than structure of an expanding channel.
Thus, Examiner maintains the rejection of Claims 1 and 4 under 35 USC 102 as being anticipated by Link.
35 USC 103
Applicant further argues that in view of the alleged allowability of Claim 1 over the amendments herein, that Claims 4, 7, and 21 rejected under 35 USC 103 over Link, Claim 3 rejected under 35 USC 103 over Link in view of Blackburn, and Claim 5 rejected under 35 USC 103 over Link in view of Wilkswo are patentable by through their dependency on Claim 1. However, as discussed above, Claim 1 is maintained as anticipated by Link under 35 USC 102. As such, its dependents rejected under 35 USC 103 are not patentable merely by virtue of their dependence on Claim 1. As such, Examiner maintains the rejections of Claims 3-5, 7, and 21 under 35 USC 103.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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