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 .
Applicant’s amendment has been considered and entered for the record.
Preliminary Remarks
Applicant’s amendment submitted on 08/27/2026 has been considered and overcomes the rejection of record under 35 U.S.C. 112b and under 35 U.S.C. 102a1.
Double Patenting
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent Application No. 16/963,324 (the 16/963.324 application has been allowed, but has not proceeded to issue and therefore, does not currently have a Patent Number; will be referred to as ‘324 for this rejection). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘324 discloses the following limitations as discussed in the table below:
18/281,514
16,963,324 (‘324)
(Original) A droplet microfluidic platform, including: a plurality of substrate layers into which various functional components are fabricated into, the functional components including at least one co-flow based droplet generator for continuous generation of cell or reagent- encapsulated droplets; at least one droplet incubation chamber for incubation of the cell or reagent-encapsulated droplets; at least one valve for trapping or releasing the droplets; a droplet detection mechanism; a sorting mechanism for sorting the droplets based on the detection result, and at least one droplet passage to interconnect the functional components; wherein the droplet microfluidic platform is capable of continuous or semi-continuous on-chip operation of droplets in a first-in first-out manner.
7. (Original) The droplet microfluidic platform of claim 1, wherein the droplet microfluidic platform comprises a sandwich multiplexed design, and wherein at least two droplet incubation chambers are in the same horizontal plane.
1. (Previously Presented) A droplet microfluidic platform comprising: a plurality of substrate layers, and a plurality of functional components, wherein the plurality of substrate layers is configured such that, when the plurality of substrate layers are stacked, one or more of the plurality of functional components is collectively formed within two or more of the plurality of substrate layers, the functional components comprising: at least one droplet generator for continuous generation of cell- encapsulated droplets; at least one merging mechanism configured to merge the cell- encapsulated droplets; at least two incubation chambers for on-chip incubation of the cell- encapsulated droplets; at least a first valve for trapping or releasing the cell-encapsulated droplets; a detection mechanism; and a second valve configured to direct the cell-encapsulated droplets from a first of the at least two incubation chambers to a second of the at least two incubation chambers; at least one fluid passage to connect the functional components; wherein the platform is capable of continuous/semi-continuous on- chip operation in a first-in first-out manner, wherein the platform comprises a sandwich design, wherein the at least two incubation chambers are in a same horizontal plane, wherein the at least two incubation chambers are configured such that the cell-encapsulated droplets move out of one of the at least two incubation chambers and travels vertically from a higher substrate layer of the platform to a lower layer of the platform to enter into another incubation chamber of the at least two incubation chambers, wherein the platform is configured such that the cell-encapsulated droplets travel vertically from a lower layer of the platform to a higher layer of the platform.
2. (Original) The droplet microfluidic platform of claim 1, further comprising a functional component for on-chip recovery of sorted droplets.
2. (Currently Amended) The droplet microfluidic platform of claim 1, further comprising a chamber configured to provide for on-chip recovery of the cell- encapsulated droplets.
3. (Original) The droplet microfluidic platform of claim 1, wherein the droplet detection mechanism is configured to detect at least one of optical, dielectric, conductivity, or vibrational spectroscopy signals.
3. (Previously Presented) The droplet microfluidic platform of claim 1, wherein the detection mechanism is configured to detect an optical, dielectric, conductivity, or vibrational spectroscopy signal.
4. (Original) The droplet microfluidic platform of claim 1, wherein the substrate layers comprises 5 to 20 layers.
4. (Original) The droplet microfluidic platform of claim 1, wherein the substrate layers comprises about 9 to about 20 polydimethylsiloxane layers.
For the newly added limitation of where the platform is free of any separate merging functionality, ‘324 discloses at least one merging component which includes only one and therefore anticipates having only one merging structure within the platform. Therefore, ‘324 teaches this limitation.
Regarding claims 6 and 7, ‘324 discloses having a plurality of layers that are stacked, but does not explicitly disclose that the platform is made from a single injection molded piece or from multiple injection molded piece. Applicant is reminded that process steps in an apparatus are not accorded patentable weight. “The patentability of a product does not depend on its method of production”. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)." Furthermore, the processing steps do not structurally define the instant application over the prior art since the claimed processing steps do not impart a distinctive structural characteristic to the final product.
Response to Arguments
Applicant's arguments filed 08/27/2026 have been fully considered but they are not persuasive. Applicant argues on page 5 and the top of page 6 that the applied reference of Guzman (‘324) discloses having more than one separate merging component versus not having any additional merging components as claimed in the instant claim set. This is not found persuasive as the disclosure of the applied reference is only used as a dictionary for the meaning of claim terms and is not applied as part of the Double Patenting rejection. In this case, the disclosure does not limit the claim term to only be limited to only multiple merging components, but the scope of the claim term also includes just one merging component. Therefore, the Double Patenting rejection is proper and will stand.
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.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
