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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 11/24/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 6 is objected to because of the following informalities: "sized and shaped to create an interference fit with a respective . Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 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.
Claim 1 recites the limitation "a positioning of the array of perfusable units mirroring the positioning of the array of wells" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. It is recommended that this limitation be amended to recite "a positioning of the array of perfusable units mirroring a positioning of the array of wells".
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
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 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Vulto et al. (WO 2017/091075 A1) (already of record) in view of Demmler et al. (US 2009/0286317 A1) (already of record).
Regarding claim 18, Vulto et al. teaches an assay plate for culturing organoids (p. 19, line 31 “in a typical use of the apparatus… cells are cultured in a microfluidic device”), the assay plate comprising: a well plate comprising an array of perfusable units (Fig. 18; p. 4, line 20 “microtiter plate”), individual perfusable units comprising: a culture well (Fig. 12 reservoir 1201 on the right); a supply well (Fig. 12 reservoir 1201 on the left); and at least one channel fluidly connecting the culture well to the supply well (Fig. 12 microfluidic channel 1202), the at least one channel being sized and shaped to allow a gravitational flow of liquid between the culture well and the supply well through the at least one channel such that tilting the assay plate can be tilted to allows fluid exchange within the individual perfusable units without spilling fluid out of the culture well or the supply well of the individual perfusable units (Figs. 14-16 and 20 show tilting of the microfluidic device where culture liquid flows between two reservoirs).
Vulto et al. teaches a bottom wall on an underside of the reservoirs (Fig. 12 at reference number 1204), but does not teach a bottom layer sheet disposed on an underside of the well plate forming a bottom layer for the array of perfusable units. However, Demmler et al. teaches a sheet disposed on the bottom of the device (para. 0068 “foil”) which allows visual inspection and gas exchange (para. 0068).
It would have been obvious to a person of ordinary skill in the art to use the Demmler et al. configuration of a foil/sheet disposed on an underside of the device in Vulto et al.’s device with a reasonable expectation that it would allow visual inspection and gas exchange. This method for improving Vulto et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Demmler 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 Vulto et al. and Demmler et al. to obtain the invention as specified in claim 18.
Regarding claim 19, Vulto et al. teaches an assay plate which is optically transparent (p. 16, line 19 “reservoir 1203 provides optical access to the microfluidic channel”), but does not teach a bottom layer sheet. However, Demmler et al. teaches a sheet disposed on the bottom of the device (para. 0068 “foil”) which allows visual inspection and gas exchange (para. 0068).
It would have been obvious to a person of ordinary skill in the art to use the Demmler et al. configuration of a foil/sheet disposed on an underside of the device in Vulto et al.’s device with a reasonable expectation that it would allow visual inspection and gas exchange. This method for improving Vulto et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Demmler 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 Vulto et al. and Demmler et al. to obtain the invention as specified in claim 19.
Regarding claim 20, Vulto et al. teaches an assay plate comprising teaches a bottom wall on an underside of the reservoirs (Fig. 12 at reference number 1204), but does not teach a bottom layer sheet disposed on an underside which is gas permeable. However, Demmler et al. teaches a gas permeable sheet disposed on the bottom of the device (para. 0068 “gas permeable foil”) which allows optimal oxygen supply and gas exchange (para. 0068).
It would have been obvious to a person of ordinary skill in the art to use the Demmler et al. configuration of a gas permeable foil/sheet disposed on an underside of the device in Vulto et al.’s device with a reasonable expectation that it would allow optimal oxygen supply and gas exchange. This method for improving Vulto et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Demmler 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 Vulto et al. and Demmler et al. to obtain the invention as specified in claim 20.
Regarding claim 21, Vulto et al. teaches an assay plate further comprising a hydrogel disposed in the culture well (p. 22, line 5 “loaded with a gel”; p. 21, line 16 “cultured in a gel or hydrogel”).
Regarding claim 22, Vulto et al. teaches an assay plate wherein, when tilted, the culture well comprises a volume greater than a volume of the supply well (p. 5, lines 2-6 “liquid level in the higher reservoir being higher than the liquid level in the lower reservoir… once leveled, the total liquid volume in the lower reservoir is higher than the total volume in the upper reservoir”; Fig. 16).
Regarding claim 23, Vulto et al. teaches an assay plate further comprising a shared sidewall separating the culture well and the supply well (Fig. 12 reservoirs 1201 share side walls surrounding third reservoir 1203), wherein the shared sidewall terminates above the bottom layer so as to at least partially form the at least one channel (Fig. 12 side walls terminate above bottom wall forming microfluidic channel 1202).
Regarding the limitation “bottom layer sheet”, Vulto et al. teaches a bottom wall on an underside of the reservoirs (Fig. 12 at reference number 1204), but does not teach a bottom layer sheet disposed on an underside of the well plate forming a bottom layer for the array of perfusable units. However, Demmler et al. teaches a sheet disposed on the bottom of the device (para. 0068 “foil”) which allows visual inspection and gas exchange (para. 0068).
It would have been obvious to a person of ordinary skill in the art to use the Demmler et al. configuration of a foil/sheet disposed on an underside of the device in Vulto et al.’s device with a reasonable expectation that it would allow visual inspection and gas exchange. This method for improving Vulto et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Demmler 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 Vulto et al. and Demmler et al. to obtain the invention as specified in claim 23.
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Vulto et al. (WO 2017/091075 A1) (already of record) in view of Demmler et al. (US 2009/0286317 A1) (already of record) as applied to claim 23 above, and further in view of Park (US 2017/0276682 A1) (already of record).
Regarding claim 24, Vulto et al. teaches an assay plate comprising shared side walls between both reservoirs which partially forms a channel (Fig. 12 reservoirs 1201 share side walls surrounding third reservoir 1203 and side walls terminate above bottom wall forming microfluidic channel 1202), but does not teach a barrier wall disposed adjacent the shared sidewall, wherein the barrier wall at least partially forms the at least one channel. However, Park teaches a barrier wall adjacent a shared sidewall, wherein the barrier wall at least partially forms the at least one channel (para. 0050 “barrier wall” seen in Figs. 5-6). Park teaches that the first chamber and second chamber are isolated from each other by the barrier wall, but are in communication through the opening formed under the barrier wall (para. 0050).
It would have been obvious to a person of ordinary skill in the art to use the Park configuration of a barrier wall in modified Vulto et al.’s device with a reasonable expectation that it would isolate the first and second chambers from each other while allowing communication through an opening formed under the barrier wall. This method for improving modified Vulto et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Park. 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 modified Vulto et al. and Park to obtain the invention as specified in claim 24.
Regarding claim 25, Vulto et al. teaches an assay plate comprising shared side walls between both reservoirs which partially forms a channel (Fig. 12 reservoirs 1201 share side walls surrounding third reservoir 1203 and side walls terminate above bottom wall forming microfluidic channel 1202), but does not teach wherein a bottom end of the shared sidewall is at least partially sloped. However, Park teaches wherein a bottom end of the shared sidewall is at least partially sloped (Fig. 6; para. 0050 “slanted downwardly”), which facilitates inflow from the first chamber to the second chamber (para. 0050).
It would have been obvious to a person of ordinary skill in the art to use the Park configuration of an at least partially sloped shared side wall in modified Vulto et al.’s device with a reasonable expectation that it would facilitate inflow from the first chamber to the second chamber. This method for improving modified Vulto et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Park. 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 modified Vulto et al. and Park to obtain the invention as specified in claim 25.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Vulto et al. (WO 2017/091075 A1) (already of record) in view of Demmler et al. (US 2009/0286317 A1) (already of record) as applied to claim 23 above, and further in view of Jung et al. (US 2016/0075985 A1) (already of record).
Regarding claim 26, Vulto et al. teaches an assay plate comprising at least one channel, but does not teach wherein the at least one channel comprises a width greater than a height. However, Jung et al. teaches a channel comprising a width (para. 0051 “width… 1 mm to 3 mm”) greater than a height (para. 0050 “depth… 100 µm to 500 µm”). Jung et al. teaches that these dimensions allow imaging to be easily performed on the device (para. 0038).
It would have been obvious to a person of ordinary skill in the art to use the Jung et al. configuration of channel with a width greater than a height in modified Vulto et al.’s device with a reasonable expectation that these dimensions would allow imaging to be easily performed. This method for improving modified Vulto et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Jung 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 modified Vulto et al. and Jung et al. to obtain the invention as specified in claim 26.
Regarding claim 27, Vulto et al. teaches an assay plate comprising at least one channel, but does not teach wherein the at least one channel comprises a height greater than a width. However, Jung et al. teaches a channel comprising a height (para. 0050 “depth… 1 µm to 5 mm”) capable of being greater than a width (para. 0051 “width… 1 mm to 3 mm”). Jung et al. teaches that these dimensions allow imaging to be easily performed on the device (para. 0038).
It would have been obvious to a person of ordinary skill in the art to use the Jung et al. configuration of channel with a height greater than a width in modified Vulto et al.’s device with a reasonable expectation that these dimensions would allow imaging to be easily performed. This method for improving modified Vulto et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Jung 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 modified Vulto et al. and Jung et al. to obtain the invention as specified in claim 27.
Allowable Subject Matter
Claims 1-11 would be allowable if rewritten or amended to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Regarding independent claim 1, Vulto et al. teaches an assay plate comprising an array of perfusable units (Fig. 18; p. 4, line 20 “microtiter plate”) comprising a culture well (Fig. 12 reservoir 1201 on the right); a supply well (Fig. 12 reservoir 1201 on the left); and at least one channel fluidly connecting the culture well to the supply well (Fig. 12 microfluidic channel 1202) configured such that tilting the plate allows fluid exchange within the perfusable units (Figs. 14-16 and 20).
Vulto et al. does not teach or suggest a combination plate comprising an array of wells which mirrors the array of perfusable units and mates with the assay plate. Demmler et al., Park, and Jung et al. do not remedy this deficiency as none of these references disclose or suggest an additional combination plate comprising an array of wells mirroring the positioning of the array of perfusable units of the assay plate and mating with the assay plate. Therefore, the prior art of record, alone or in combination, does not disclose, teach, or suggest this noted feature within the claim environment.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Trietschi et al. (WO 2016/195480 A1) (already of record) discloses a microfluidic plate including wells connected by a channel.
Conclusion
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799