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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/06/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification lacks antecedent basis for the fifth, sixth and seventh channels of the second droplet generator.
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 following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 12 and 13 are rejected under 35 U.S.C. 102a1 as being anticipated by Hiddessen et al. (US 2014/0134623 A1 – hereafter ‘623).
‘623 discloses a system for generating a mixture of droplets (Abstract) that includes the following limitations for claim 1:
“A gel-encapsulated cell production apparatus”: ‘623 discloses an apparatus that encapsulates a cell ([0100]) where this is being interpreted as the gel-encapsulated cell production apparatus of the instant application.
“a first droplet generator configured to generate a first droplet in which a processed cell is encapsulated”: ‘623 discloses a first droplet generator (generator 110; Fig. 1; [0060]) that encapsulates a cell.
“a second droplet generator configured to generate a second droplet in which a gelator is encapsulated”: ‘623 discloses a second droplet generator (generator 120; Fig. 1; [0060]) that would include a gelator.
“a gel-encapsulated cell generator connected to the first droplet generator and the second droplet generator via a channel and configured to blend the first droplet and the second droplet and generate a gel-encapsulated cell, the gel-encapsulated cell being the cell encapsulated in a gel originating in the gelator.”: ‘623 discloses a droplet combining module (module 131; Fig. 1; [0064]) that is connected to the first and second droplet generators and is fully capable of generating gel-encapsulated cell droplets.
For claim 2, ‘623 discloses that that the first droplet generator generates an emulsion ([0069]) that can include a cell and a reagent.
For claim 3, ‘623 discloses that the first droplet generator includes three channels ([0064]; [0069]; Fig. 1) where these channels can supply a cell, a processing reagent and an oil. ‘623 discloses that the three channels meet to form a droplet (Fig. 1; [0064). ‘623 further discloses emulsion generators (Fig. 1; [0145]) that is downstream from the droplet generator that is being interpreted as the promoter of the instant application.
For claim 4, ‘623 the temperature of the emulsion generator by a temperature adjustment such as an incubator ([0024]).
For claim 12, the specific cell reagent and gelator are drawn to the material operated on by the apparatus which does not structurally define the claimed invention over the prior art. See MPEP §2115.
For claim 13, ‘623 discloses that the droplet generators are part of a cartridge ([0120]) where this cartridge is being interpreted as the base plate of the instant application.
Therefore, ‘623 meets the limitations of claim 1-4, 12 and 13.
Allowable Subject Matter
Claims 5-11 are 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: For claim 5, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a gel-encapsulated cell production apparatus where the promoter includes a channel having a width smaller than a particle size of the third droplet.
Claim 6 would be allowable for the same reasons as claim 5.
For claim 7, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a gel-encapsulated cell production apparatus that includes a blender configured to blend the first droplet and the second droplet to generate a blended droplet and a stimulus introducer configured to give the blended droplet a stimulus for inducing gelation of the cell with the gelator.
Claims 8-11 would be allowable for the same reasons as claim 7.
The closest prior art is Heddessen et al. (US 2014/0134623 A1) that discloses a system for generating droplets that includes three droplet generators, but Heddessen does not teach the diameter of the channel of the promoter and does not teach or suggest the stimulus introducer.
Claims 14-16 are allowed.
The following is an examiner’s statement of reasons for allowance: For claim 14, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a cell culture system that includes the following limitations: a gel-encapsulated cell production apparatus comprising: a first droplet generator configured to generate a first droplet in which a processed cell is encapsulated; a second droplet generator configured to generate a second droplet in which a gelator is encapsulated; and a gel-encapsulated cell generator connected to the first droplet generator and the second droplet generator via a channel and configured to blend the first droplet and the second droplet and generate a gel-encapsulated cell, the gel-encapsulated cell being the cell encapsulated in a gel originating in the gelator; and a culturing unit configured to culture the cell encapsulated in the gel.
Claims 15 and 16 would be allowed for the same reasons as Claim 14.
The closest prior art is Heddessen et al. (US 2014/0134623 A1) that discloses a system for generating droplets that includes three droplet generators, but Heddessen does not teach the droplet generators used with a culture vessel.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kamino (US 2022/0371018 A1) discloses a device that includes a droplet generator with processing circuitry that detects a reaction between an enzyme and a substrate.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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