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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/23/2025 has been entered.
Claim Rejections - 35 USC § 102
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 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, 5 & 16-22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fang et al. (US 2021/0291173).
Regarding claim 1, Fang et al. teach:
1. A microfluidic device, comprising:
a substrate (e.g., 102) having at least one droplet holder (e.g., array of wells 122); and
a lid (e.g., 112) configured to face the substrate such that a flow path (e.g., 106) is formed over the at least one droplet holder between the lid and the substrate (see Fig. 2 & ¶ 0025 for example) and that the flow path (106) is connected to the at least one droplet holder (see Fig. 2 for example), wherein
a surface of the lid is smooth (this limitation is sufficiently broad to have read on a planar surface of the second substrate 112 (lid)),
the substrate and the lid are made of a same material (see i.e., Figs. 2, 5-7 showing the substrate (102) and the lid (112) are made of planar materials), and
the lid is positioned over the at least one droplet holder such that the flow path has a height from an opening of the at least one droplet holder to the lid in a range of more than 0 μm and 30 μm or less (see i.e., “a depth of channel 106 is a distance between floor 110 of the flow channel and a ceiling 111 of the flow channel. For example, ceiling 111 of flow channel 106 can be defined by second substrate 112 (e.g., an interior surface 113 of the second substrate). In some embodiments, the depth of flow channel 110 is about 30 μm” ¶ 0031).
With regard to limitations in claim 1 (e.g., [...] that generation of air bubbles in the microfluidic device is suppressed to a rate of 14% or less.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2, 3, 5 & 16-22, Fang et al. teach:
Claim 2. The microfluidic device according to claim 1, wherein the at least one droplet holder is at least one pore (i.e., pore of the wells 122; see also various film materials in ¶ 0034 for example) formed in the substrate (see i.e., “microfluidic device 100 comprises an array of wells 122 disposed in film 120. FIG. 3 is an atomic force microscope image of some embodiments of film 120 and the array of wells 122 disposed in the film as shown in FIG. 2. Wells 122 can be configured as apertures or depressions in film 120” ¶ 0035).
Claim 3. The microfluidic device according to claim 1, wherein the at least one droplet holder is a plurality of wells (e.g., array of wells 122) formed on a surface of the substrate (see Figs. 2-3 & ¶ 0034-0035 for example).
Claim 5. The microfluidic device according to claim 1, wherein the at least one droplet holder is a plurality of droplet holders (e.g., array of wells 122).
Claim 16. The microfluidic device according to claim 1, wherein the lid is positioned over the at least one droplet holder such that the height of the flow path from the opening of the at least one droplet holder to the lid in a range of more than 2 μm to 30 μm (e.g., “about 40 μm” ¶ 0031).
Claim 17. The microfluidic device according to claim 1, wherein the lid is positioned over the at least one droplet holder such that the height of the flow path from the opening of the at least one droplet holder to the lid in a range of more than 3 μm to 25 μm (e.g., “about 30 μm” ¶ 0031).
Claim 18. The microfluidic device according to claim 1, wherein the lid is positioned over the at least one droplet holder such that the height of the flow path from the opening of the at least one droplet holder to the lid in a range of more than 5 μm to 20 μm (e.g., “about 30 μm” ¶ 0031).
Claim 19. The microfluidic device according to claim 1, wherein the lid is positioned over the at least one droplet holder such that the height of the flow path from the opening of the at least one droplet holder to the lid in a range of more than 8 μm to 18 μm (e.g., “about 30 μm” ¶ 0031).
Claim 20. The microfluidic device according to claim 1, wherein the at least one droplet holder is an microwell array (e.g., array of wells 122) comprising a bottom layer (e.g., film 120) formed on the surface of the substrate (see i.e., “microfluidic device 100 comprises a film 120 disposed on first substrate 102.” ¶ 0034) and a well layer formed on the bottom layer (see i.e., a combination of film materials: “Film 120 can be formed from a glass material, a glass-ceramic material, silicon, silicon dioxide, a metal material, a metal oxide material, a polymeric material, another suitable material, or a combination thereof.” ¶ 0034; see also “a plurality of markers 140 disposed in film 120. [...] Additionally, or alternatively, marker 140 comprises a macro-feature (e.g., a line, a square area, a rectangular area, a circular area, a ring structure, or another shaped area that is unpatterned or free of wells). Such macro-feature can be introduced before bead deposition, for example, by printing resist materials or polymeric ink, or by placing a tape having a specific shape. Additionally, or alternatively, marker 140 comprises an array of markers.” ¶ 0036) such that the microwell array has a plurality of microwells formed in the well layer (see ¶ 0034-0037 for example).
Claim 21. The microfluidic device according to claim 1, wherein the lid is curved so as to be projected toward the substrate in vicinity of a center of the lid (see annotated Figs. 2 & 7 for example).
Claim 22. The microfluidic device according to claim 1, further comprising a peripheral member (e.g., sidewall 108 in Figs. 2, 5, 7; see also e.g., spacer 102d in Fig. 6) configured to support the lid (see Figs. 2-7), wherein the lid is curved on an inside of the peripheral member (see annotated Fig. 7 for example).
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Claim Rejections - 35 USC § 102
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 4 & 8 is/are rejected under 35 U.S.C. 102(a2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Fang et al. (US 2021/0291173).
Regarding claim 4, the claim recites “wherein the plurality of wells is formed in a region of the surface of the substrate such that a ratio of a total open area of the wells is in a range of 23% to 90% per unit area of the region” without specifying dimensional requirement of the region. Fang et al. teach “The array of wells 122 can be configured as an ordered array (e.g., a hexagonal array) or a non-ordered array (e.g., a random array).” (¶ 0035), and it would appear a region can be any arbitrary region such that a ratio of a total open area of the wells is in a range of 23% to 90% per unit area of the region. In the event that the claimed range of ratio is not shown with sufficient specificity, then it would have been obvious to one having ordinary skill in the art to adjust the array of wells in any order such that a ratio of a total open area of the wells is in a range of 23% to 90% per unit area of the region based upon its suitability of intended use as disclosed by Fang et al. (¶ 0023-0024, 0035, 0075+). 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 dimension necessary for the design of the device would have been obvious to one of ordinary skill in the art.
Regarding claim 8, the claim recites “wherein the plurality of droplet holders have a total volume in a range of 5% to 40% of a volume of the flow path” without specifying the total volume of the droplet holders or the volume of the flow path. Fan et al. teach various range of volumes and well dimensions in ¶ 0031, 0040, and it would appear a volume of the flow path can be any arbitrary volume such that the droplet holders have a total volume in a range of 5% to 40% of a volume of the flow path. In the event that the claimed range of a volume is not shown with sufficient specificity, then it would have been obvious to one having ordinary skill in the art to adjust the array of wells to have a total volume in a range of 5% to 40% of a volume of the flow path based upon its suitability of intended use as disclosed by Fang et al. (¶ 0023-0024, 0031, 0040, 0075+). 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 dimension necessary for the design of the device would have been obvious to one of ordinary skill in the art.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 6, 7 & 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. (US 2021/0291173).
Regarding claims 6, 7 & 9, Fang et al. teach various dimensions of the wells (¶ 0031, 0040). In addition, Fang et al. teach the volume of the wells (122) can be varied, see “wells 122 comprise apertures extending entirely through film 120 such that bottom surfaces of the array of wells comprise exposed portions of floor 110 of flow channel 106. Additionally, or alternatively, wells 122 comprise depressions extending partially through film 120 such that bottom surfaces of the array of wells comprise the film (e.g., an interior portion of the film exposed by forming the depressions).” ¶ 0035, and the total volume of the droplet holders would also vary on markers in the wells “the array of wells 122 comprise a marker 140. FIG. 4 is a scanning electron microscopic image of some embodiments of microfluidic device 100 comprising a plurality of markers 140 disposed in film 120. For example, markers 140 comprise fluorescent beads disposed in a portion of wells 122.” ¶ 0036. However, Fang et al. do not explicitly teach: Claim 6. The microfluidic device according to claim 5, wherein each of the plurality of droplet holders has a volume in a range of 10 fL to 100 pL. Claim 7. The microfluidic device according to claim 5, wherein the plurality of droplet holders have a total volume in a range of 0.2 μL to 2.0 μL. Claim 9. The microfluidic device according to claim 1, wherein the at least one droplet holder has a depth in a range of 3% to 150% of the height of the flow path.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the volume of the droplet holder based upon its suitability of intended use as disclosed by Fang et al. (¶ 0023-0024, 0035-0036, 0075+). 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 dimension necessary for the design of the device would have been obvious to one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 06/23/2025 have been fully considered but they are not persuasive.
Drawings objection to claim 5, and Claim objections have been withdrawn.
35 USC § 112 rejections have been withdrawn.
In response to the Applicant's argument that Fang et al. fail to teach “a substrate having at least one droplet holder; and a lid configured to face the substrate such that a flow path is formed over the at least one droplet holder between the lid and the substrate and that the flow path is connected to the at least one droplet holder, wherein a surface of the lid is smooth, the substrate and the lid are made of a same material, and the lid is positioned over the at least one droplet holder such that the flow path has a height from an opening of the at least one droplet holder to the lid in a range of more than 0 μm and 30 μm or less [...]”, Examiner disagrees.
Fang et al. teach, among other things, a substrate (e.g., 102) having at least one droplet holder (e.g., array of wells 122); and a lid (e.g., 112) configured to face the substrate such that a flow path (e.g., 106) is formed over the at least one droplet holder between the lid and the substrate (see Fig. 2 & ¶ 0025 for example) and that the flow path (106) is connected to the at least one droplet holder (see Fig. 2 for example), wherein a surface of the lid is smooth (this limitation is sufficiently broad to have read on a planar surface of the second substrate 112 (lid)), the substrate and the lid are made of a same material (see i.e., Figs. 2, 5-7 showing the substrate (102) and the lid (112) are made of planar materials), and the lid is positioned over the at least one droplet holder such that the flow path has a height from an opening of the at least one droplet holder to the lid in a range of more than 0 μm and 30 μm or less (see i.e., “a depth of channel 106 is a distance between floor 110 of the flow channel and a ceiling 111 of the flow channel. For example, ceiling 111 of flow channel 106 can be defined by second substrate 112 (e.g., an interior surface 113 of the second substrate). In some embodiments, the depth of flow channel 110 is about 30 μm” ¶ 0031).
In response to applicant's argument that Fang et al. fail to teach “[...] that generation of air bubbles in the microfluidic device is suppressed to a rate of 14% or less”, these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Applicant is encouraged to amend the claims to include additional structural elements of the device. Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JILL A. WARDEN can be reached at (571) 272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798