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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/08/2025 has been entered.
Claim Objections
Claim 30 is objected to because of the following informalities: Examiner suggests amending “[...] -160 µm” in L2 to read “[...] to 160 µm”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 3, 4, 6, 7, 30 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.
Claims 1 & 30 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. Claim 1 recites “wherein the main channel has a width of about 50 µm to 1000 µm and the width is constant along the length of the main channel, wherein the main channel has a height of about 30 µm to 150 µm and the height is constant along the length of the main channel, wherein the main channel has a length of about 10 mm to 60 mm; [...] wherein each of the first plurality of migration microchannels has a height of about 3 µm to 7 µm and the height is constant along the length of the migration microchannels, wherein each of the first plurality of migration microchannels has a width of about 8 µm to 40 µm and the width is constant along the length of the migration microchannels.” The claim lacks clarity because it defines the main channel using specific ranges for width and height (noting these dimensions are constant), while also reciting a separate range for the main channel’s length (about 10 mm to 60 mm). The limitation to the first plurality of migration microchannels is similarly unclear because the limitation defines each of the first plurality of migration microchannels using specific ranges for length and height (noting these dimensions are constant), yet also recites a separate range for the first plurality of migration microchannels’ length (about 110 to 180 µm, assuming that the length of the migration microchannels is referring to the length of the first plurality of migration microchannels). For this reason, claim 30 is also unclear.
Claim 1 is unclear reciting “a length of about 110 to 180 µm” because the unit for ‘110’ is not specified.
Claim 1 recites the limitation "the length of the main channel [...]" in L10, L12. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the length of the migration microchannels" in L44, L46. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 is unclear reciting “about 120-160 µm” because the unit for ‘120’ is not specified.
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 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, 3, 4, 6, 7 & 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamm et al. (US 2014/0057311).
Regarding claim 1, Kamm et al. teach:
1. A device comprising:
a microfluidic chip substrate (¶ 0008+) having a plurality of microfluidic channels formed thereon (see Figs. 26A-B for example), the microfluidic channels comprising:
a main channel having a first end and a second end, a first inlet at the first end of the main channel and a first outlet at the second end of the main channel, wherein the first inlet is in fluidic communication with the main channel, and wherein the first outlet is in fluidic communication with the main channel (see annotated Fig. 26B & Claim 74 for example), wherein the main channel is a single passage channel (see i.e., the device comprises one or more fluid channels, wherein each fluid channel has a primary flow direction (a direction in which the fluid primarily flows). The one or more fluid channels can have the same primary flow direction ¶ 0057; see also the main channel in annotated Fig. 26B shows a single passage at the first end and the second end) having a rectangular cross-section (see ¶ 0060 for example), wherein the main channel has a width of about 50 µm to 1000 µm, wherein the main channel has a height of about 30 µm to 150 µm (see i.e., the one or more fluid channels has a height of about [...] 50 μm, 100 μm, 125 μm, 150 μm, [...] ¶ 0097), wherein the main channel has a length of about 10 mm to 60 mm (see i.e., “Channel Length = 10 mm” in Fig. 1 for example);
a first outer channel oriented substantially parallel to and on a first side of the main channel, the first outer channel having a first end and a second end, a second inlet at the first end of the first outer channel, and a second outlet at the second end of the first outer channel, wherein the second inlet is in fluidic communication with the first outer channel (see annotated Fig. 26B & Claim 74 for example);
a first collection channel disposed between the main channel and the first outer channel, the first collection channel oriented substantially parallel to both the main channel and the first outer channel, wherein the first collection channel comprises a first end and a second end, and wherein the first collection channel is in fluidic communication with a first flushing port at the first end of the first collection channel and the first collection channel having a collection outlet at the second end of the first collection channel (see annotated Fig. 26B for example);
a first plurality of migration microchannels (see i.e., microchannels between posts as shown in Figs. 1 & 19A for example) disposed between and connecting the first side of the main channel to the first collection channel and oriented substantially perpendicular to the main channel and first collection channel, wherein the first plurality of migration microchannels are in fluidic communication with both the main channel and the first collection channel (see annotated Figs. 1 & 26B for example) and wherein each of the first plurality of migration microchannels has a height less than a height of the main channel and less than a height of the first outer channel (see i.e., “the device could comprise a high media channel of about 200 µm, and a high gel channel of about 400 µm [...] the one or more fluid channels has a height of about [...] 225 μm, 250 μm, 300 μm, 350 μm, 400 μm, and 500 μm; and the one or more gel channels has a height of about 20 μm, 40 μm, 80 μm, 100 μm, 150 μm [...].” ¶ 0097); and
a second plurality of migration microchannels (see i.e., microchannels between posts as shown in Figs. 1, 19A, and annotated Fig. 26B for example) disposed between and connecting the first collection channel to the first outer channel and oriented substantially perpendicular to the first collection channel and first outer channel (see annotated Figs. 1 & 26B for example), wherein the second plurality of migration microchannels are in fluidic communication with both the first collection channel and the first outer channel (see annotated Figs. 1 & 26B for example) and wherein each of the second plurality of migration microchannels has a height less than a height of the main channel and less than a height of the first outer channel (see i.e., “the device could comprise a high media channel of about 200 µm, and a high gel channel of about 400 µm [...] the one or more fluid channels has a height of about [...] 225 μm, 250 μm, 300 μm, 350 μm, 400 μm, and 500 μm; and the one or more gel channels has a height of about 20 μm, 40 μm, 80 μm, 100 μm, 150 μm [...].” ¶ 0097),
wherein each of the first plurality of migration microchannels has a length of about 110 to 180 µm (see i.e., Fig. 1 showing the width of the gen region is 1200 μm, and the distance between top to top trapezoid posts is 900 μm, therefore the length for trapezoid posts (migration microchannels) is 150 μm; see annotated Fig. 1 for example), wherein each of the first plurality of migration microchannels has a width of about 8 µm to 40 µm (i.e., the post-to-post spacing is from about 1 micrometer [...], 5 micrometers [...], about 10 micrometers [...]; see also the spacing between posts is about 10, 20, 30, 40, [...] micrometers ¶ 0095).
Regarding claim 1, Kamm et al. teach: wherein each of the first plurality of migration microchannels has a height of about 20 μm (¶ 0097). In addition, Kamm et al. teach various channel dimensions and the considerations for channel designs (¶ 0089-0098+; see i.e., The plurality of posts in the device can be arranged in a variety of orientations within a device and will depend upon the intended use for the device. [...] The size and shape of the posts can vary to maximize their effectiveness. ¶ 0089-0090; The distance between successive posts in a gel cage, the height and width of a gel cage (e.g., channel), and the length of a gel cage region determine the probability of successfully filling the gel cage region, and therefore manufacturing the device. ¶ 0092; Closer post spacing creates a stronger surface tension between the posts. This means that, all other things being equal, a channel with very closely spaced posts can be filled a greater distance than one with widely spaced posts. However, closely spaced posts limit the amount of gel-media interaction, and make it hard for cells to grow into the 3D gel matrix. There is a tradeoff between device quality to the user (who wants wider gel regions) and manufacturability (as wide gel regions make it harder to successfully fill the device). ¶ 0095; A shorter media channel allows the use of less media, which saves costs when rare and expensive media reagents are used. The higher gel regions allow freer movement and less interaction and interference from the mechanically stiff "ceiling" and "floor" of the device (e.g., see FIG. 4). ¶ 0097; Typically, wider gel channels are easier to fill, and narrower channels have higher resistance, and therefore require more pressure to fill. [...] There is interplay between post spacing, channel width, and the maximum fillable channel length. ¶ 0098). However, Kamm et al. do not explicitly teach: wherein each of the first plurality of migration microchannels has a height of about 3 µm to 7 µm.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to adjust channel dimensions to increase the probability of successfully filling the gel cage region, and therefore manufacturing the device (¶ 0092). As noted by the Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141. Therefore, selecting appropriate size/dimension necessary for the design of the system would have been obvious to one of ordinary skill in the art, in light of the above KSR decision and to gain the advantages of reduction of reagent consumption and increased quality.
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Regarding claims 3, 6 & 7, modified Kamm et al. teach:
3. The device of claim 1, wherein the first outer channel independently has a width of about 50 µm to 1000 µm, a height of about 30 µm to 150 µm, and a length of about 10mm to 60mm (see ¶ 0097, 0099, 0222 & Fig. 4).
6. The device of claim 1, further comprising: a second outer channel on a second side of the main channel opposite the first outer channel, the second outer channel oriented substantially parallel to the main channel and first outer channel, the second outer channel having a first end and a second end, a third inlet at the first end of the second outer channel, and a third outlet at the second end of the second outer channel, wherein the third inlet is in fluidic communication with the second outer channel (see annotated Fig. 26B for example); a third plurality of migration microchannels connecting the main channel to the second outer channel and oriented substantially perpendicular to the main channel and second outer channel, wherein the third plurality of migration microchannels are in fluidic communication with the main channel and the second outer channel (see annotated Fig. 26B for example), wherein the third plurality of migration microchannels and the first plurality of migration microchannels are directly opposite one another (see annotated Fig. 26B for example) and in the line-of-sight on one another (see i.e., the device comprises a substrate comprised of an optically transparent material ¶ 0117); and one or more second-side collection channels located in between the main channel and second outer channel, oriented substantially parallel to both the main channel and second outer channel, and intersecting and in fluidic communication with the third plurality of migration microchannels, wherein the one or more second-side collection channels each comprises a first end and a second end, and wherein each second-side collection channel is in fluidic communication with a second flushing port at the first end of each second-side collection channel and each second-side collection channel having an individual collection outlet at the second end of each second-side collection channel (see annotated Fig. 26B for example).
7. The device of claim 6, wherein the second outer channel, third plurality of migration microchannels, and one or more second-side collection channels have a configuration that substantially mirrors a configuration of the first outer channel, the first plurality of migration microchannels, and the first collection channel (see annotated Fig. 26B for example).
Regarding claims 4 & 30, Kamm et al. teach: wherein the first collection channel has a height of about 30 µm to 150 µm (¶ 0097). In addition, Kamm et al. teach various channel dimensions and the considerations for channel designs (¶ 0089-0098+; see i.e., The plurality of posts in the device can be arranged in a variety of orientations within a device and will depend upon the intended use for the device. [...] The size and shape of the posts can vary to maximize their effectiveness. ¶ 0089-0090; The distance between successive posts in a gel cage, the height and width of a gel cage (e.g., channel), and the length of a gel cage region determine the probability of successfully filling the gel cage region, and therefore manufacturing the device. ¶ 0092; Closer post spacing creates a stronger surface tension between the posts. This means that, all other things being equal, a channel with very closely spaced posts can be filled a greater distance than one with widely spaced posts. However, closely spaced posts limit the amount of gel-media interaction, and make it hard for cells to grow into the 3D gel matrix. There is a tradeoff between device quality to the user (who wants wider gel regions) and manufacturability (as wide gel regions make it harder to successfully fill the device). ¶ 0095; A shorter media channel allows the use of less media, which saves costs when rare and expensive media reagents are used. The higher gel regions allow freer movement and less interaction and interference from the mechanically stiff "ceiling" and "floor" of the device (e.g., see FIG. 4). ¶ 0097; Typically, wider gel channels are easier to fill, and narrower channels have higher resistance, and therefore require more pressure to fill. [...] There is interplay between post spacing, channel width, and the maximum fillable channel length. ¶ 0098). However, Kamm et al. do not explicitly teach: 4. The device of claim 1, wherein the first collection channel has a width of about 50 µm to 200 µm. 30. The device of claim 29, wherein the length of each of the of the first plurality of migration microchannels is about 120-160 µm.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to adjust channel dimensions to increase the probability of successfully filling the gel cage region, and therefore manufacturing the device (¶ 0092). As noted by the Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141. Therefore, selecting appropriate size/dimension necessary for the design of the system would have been obvious to one of ordinary skill in the art, in light of the above KSR decision and to gain the advantages of reduction of reagent consumption and increased quality.
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
The Applicant’s arguments and amendments have been considered and have been addressed within the above rejection(s).
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798