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 .
Response to Arguments
Applicant’s arguments filed 2/25/2026 have been considered but they are not persuasive.
Applicant has amended claim 10 to recite “a plurality of optical sensors, each optical sensor positioned adjacent to the bottom surface of a corresponding microchannel and within the corresponding microchannel”. The examiner agrees that the sensors positioned adjacent to the microchannels in Fig. 6A of Coppeta et al. does not read on the newly added limitation of “within the corresponding microchannel”; however, the sensors shown in Fig. 6C of Coppeta et al. do read on the newly added limitation as sensors 605a-d are positioned within the microchannels. Applicant has also amended claim 10 to recite a “light source positioned to direct light towards the bottom surface”. Izquierdo et al. discloses that the light source directs light toward the microfluidic channel, which reads on the newly added limitation as the “bottom surface” is part of the microchannel.
Applicant argues on pp. 9-10 of Remarks that the examiner fails to provide a reasoned motivation to combine Coppeta et al. and Izquierdo et al. This is not persuasive as Izquierdo et al. discloses that an opaque layer in a microfluidic device restricts mixing of light emitted from different microfluidic chambers (para. 0261) and a light source excites biological material (abstract). One of ordinary skill in the art would recognize the advantages of restricting light mixing between microfluidic chambers when light excites biological material, and one of ordinary skill in the art would be motivated to include these features in a microchannel cell culture device. Thus, the examiner maintains that it would have been obvious to one of ordinary skill in the art to combine the teachings of Coppeta et al. with the teachings of Izquierdo et al.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the light shielding layer must be shown or the feature canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 (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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Coppeta et al. (US
2018/0142196 A1) (already of record) in view of Izquierdo et al. (US 2015/0107993 A1) (already of record).
Regarding claim 10, Coppeta et al. teaches a microchannel cell culture device (abstract), comprising: a well plate (Fig. 1 105 cell culture platform) defining an array of tissue modeling environments (abstract “tissue modeling environments”), each tissue modeling environment including a first structural layer including a plurality of fluid reservoirs (Fig. 1 110a first fluid reservoir, 110b second fluid reservoir, 110c third fluid reservoir, 110d fourth fluid reservoir), and a second structural layer including at least one microchannel (Fig. 2 125a first microchannel, 125b second microchannel) fluidically coupling a first fluid reservoir of the plurality of fluid reservoirs to a second fluid reservoir of the plurality of fluid reservoirs (para. 0046 "microchannel 125a fluidically couples the first fluid reservoir 110a to the third fluid reservoir"), a bottom surface of the second structural layer being optically transparent (para. 0009 "polystyrene"); and a plurality of optical sensors (para. 0083 "optical sensors"), each optical sensor positioned adjacent to the bottom surface of a corresponding microchannel and within the corresponding microchannel to scan the bottom surface of the corresponding microchannel of a corresponding tissue modeling environment (Fig. 6C 605a-d electrodes).
Coppeta et al. does not teach a light shielding layer that is substantially opaque or a light source positioned to direct light towards the bottom surface. However, Izquierdo et al. teaches a substantially opaque sub-layer (39) which restricts mixing of light emitted from different microfluidic chambers (para. 0261) and a light source for exciting biological material which is directed to the microfluidic channel (abstract). Izquierdo et al. teaches the sub-layer positioned adjacent to a top of a second layer containing a microfluidic channel (Fig. 4 39 opaque sublayer on top of 4 chip containing 6 microfluidic channel, and under 50 transparent substrate). It would have been obvious to a person of ordinary skill in the art to use the Izquierdo et al. configuration of a substantially opaque sub-layer adjacent to a top of a second layer containing a microfluidic channel and a light source in Coppeta et al.'s device with a reasonable expectation that the opaque sub-layer would restrict mixing of light from different microfluidic chambers, and the light source would excite biological material. This method for improving Coppeta et al.'s device was within the ability of one of ordinary skill in the art based on the teachings of Izquierdo et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Coppeta et al. and Izquierdo et al. to obtain the invention as specified in claim 10.
Regarding the limitation "focusing light to a target portion of the microchannel cell culture device", it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior
art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114
II). Therefore, the apparatus disclosed by Coppeta et al. in view of lzquierdo et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for exciting and causing activity of biological material (abstract) only at the microfluidic chambers with an opaque sub-layer (para. 0261) and would be structurally capable of focusing light to a target portion of the microchannel cell culture device absent clear evidence otherwise.
Regarding Izquierdo et al.’s disclosure of an apparatus for evaluating water pollution, the problem faced by the inventor of the instant application is shielding and focusing light to certain portions of the microfluidic device. Izquierdo et al.’s device is reasonably pertinent to solving this problem.
Regarding claim 11, Coppeta et al. teaches a microchannel culture device wherein each tissue modeling environment includes at least two microchannels, a first microchannel fluidically coupling the first fluid reservoir to the second fluid reservoir (Fig. 2 125a first microchannel connecting 110a first fluid
reservoir to 110c third fluid reservoir) and a second microchannel fluidically coupling a third fluid reservoir to a fourth fluid reservoir (Fig. 2 125b second microchannel connecting 110b second fluid reservoir to 110d fourth fluid reservoir).
Regarding claim 12, Coppeta et al. teaches a microchannel culture device wherein at least a portion of the first microchannel overlaps at least a portion of the second microchannel (Fig. 2 125a first
microchannel, 125b second microchannel; para. 0003).
Regarding claim 13, Coppeta et al. teaches a microchannel culture device further comprising a
membrane layer extending between the overlapping portions of the first and second microchannels (Fig.
3C 140 membrane; para. 0048).
Regarding claim 14, Coppeta et al. teaches a microchannel culture device wherein a bottom
surface of the overlapping portions of the first and second microchannels is optically transparent (para.
0009 "polystyrene").
Conclusion
THIS ACTION IS MADE FINAL. 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 ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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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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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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